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47
《》202172211，，2021101
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2021826
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Article 42 For serious adverse events related to clinical trial medical devices during clinical trials of medical devices, or other serious safety risk information, clinical trial sponsors shall, in accordance with relevant requirements, report to the province and autonomous region where the clinical trial institution is located.
, The municipal drug supervision and administration department reports and adopts risk control measures
.
If no risk control measures are taken, the drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures in accordance with the law
.
, The municipal drug supervision and administration department reports and adopts risk control measures
.
If no risk control measures are taken, the drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures in accordance with the law
.
Article 43 When a large-scale clinical trial medical device-related serious adverse event occurs in a medical device clinical trial, or other major safety issues, the sponsor shall suspend or terminate the medical device clinical trial, and report to the province where the clinical trial institution is located.
, Autonomous regions and municipalities directly under the Central Government's drug supervision and administration department reports
.
If it is not suspended or terminated, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures in accordance with the law
.
, Autonomous regions and municipalities directly under the Central Government's drug supervision and administration department reports
.
If it is not suspended or terminated, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures in accordance with the law
.
Article 44 In the case of an approved clinical trial under any of the following circumstances, the State Drug Administration may order the applicant to terminate the clinical trial of a medical device:
(1) The clinical trial application materials are false;
(2) The latest research has confirmed that there are problems with the ethics and science of the originally approved clinical trial;
(3) Other circumstances that should be terminated
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Article 45 The clinical trial of a medical device shall be implemented within 3 years after approval; the clinical trial application for a medical device shall be automatically invalidated if no subject has signed the informed consent within 3 years from the date of approval
.
If clinical trials are still needed, a new application should be made
.
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If clinical trials are still needed, a new application should be made
.
Article 46 For medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases without effective treatments, medical observations may benefit patients.
After ethical review and informed consent, medical devices can be used for medical treatment.
The device clinical trial institution is free for other patients with the same condition, and its safety data can be used for medical device registration applications
.
After ethical review and informed consent, medical devices can be used for medical treatment.
The device clinical trial institution is free for other patients with the same condition, and its safety data can be used for medical device registration applications
.
Section 3 Verification of Registration System
Article 47 The applicant shall submit relevant materials related to the quality management system related to product development and production when applying for registration.
The drug regulatory authority accepting the registration application considers it necessary to check the quality management system during the technical review of the product.
, Should organize and carry out the quality management system verification, and can read the original data as needed
.
The drug regulatory authority accepting the registration application considers it necessary to check the quality management system during the technical review of the product.
, Should organize and carry out the quality management system verification, and can read the original data as needed
.
Article 48 The inspection of the quality management system of domestic Class III medical devices shall be carried out by the State Administration’s Device Evaluation Center notifying the applicant’s drug regulatory department in the province, autonomous region, or municipality where the applicant is located
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The domestic second-class medical device quality management system verification is organized and carried out by the drug regulatory department of the province, autonomous region, or municipality where the applicant is located
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Article 49 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall carry out quality management system verification in accordance with the requirements of the medical device production quality management specifications, focusing on whether the applicant has established a quality compatible with the product in accordance with the requirements of the medical device production quality management specifications The management system, as well as the design and development, production management, quality control and other content related to product development and production are checked
.
.
During the verification process, the authenticity of the inspection products and clinical trial products should be verified at the same time, with emphasis on reviewing the relevant records of the design and development process, as well as the relevant records of the production process of the inspection products and clinical trial products
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When submitting a self-inspection report, the applicant, the filing person or the trustee institution shall conduct key inspections on the inspection capabilities and inspection results during the development process
.
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Article 50 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government may conduct quality management system verification through document review or on-site inspection
.
According to the applicant's specific situation, supervision and inspection, the product applied for registration this time and the previous inspection product production conditions and process comparison, etc.
, determine whether on-site inspection and inspection content, to avoid repeated inspections
.
.
According to the applicant's specific situation, supervision and inspection, the product applied for registration this time and the previous inspection product production conditions and process comparison, etc.
, determine whether on-site inspection and inspection content, to avoid repeated inspections
.
Article 51 When the National Bureau’s Device Review Center conducts technical review of imported Class II and Class III medical devices, if it considers that it is necessary to conduct quality management system verification, it shall notify the National Bureau of Review and Inspection Center to conduct verification in accordance with relevant requirements
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Section 4 Product Registration
Article 52 The applicant shall submit an application for medical device registration after completing the safety and effectiveness research supporting the registration of medical devices and being ready to accept the verification of the quality management system, and submit an application for medical device registration in accordance with relevant requirements through online registration applications, etc.
Submit the following registration application materials to the drug regulatory authority:
Submit the following registration application materials to the drug regulatory authority:
(1) Product risk analysis data;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation data;
(5) Product manuals and label samples;
(6) Quality management system documents related to product development and production;
(7) Other materials required to prove that the product is safe and effective
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Article 53 After receiving the application, the drug supervision and administration department shall review the application materials and deal with it separately according to the following conditions:
(1) The application matters are within the scope of the administrative agency's powers, and the application materials are complete and meet the formal review requirements, it will be accepted;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(3) If the application materials are incomplete or do not conform to the legal form, the applicant shall be notified on the spot or within 5 days of all the contents that need to be supplemented and corrected at one time.
If the application is not notified within the time limit, the application shall be accepted as of the day when the application materials are received;
If the application is not notified within the time limit, the application shall be accepted as of the day when the application materials are received;
(4) If the application matters are not within the scope of the administrative agency's powers in accordance with the law, it shall immediately make a decision not to accept the application, and notify the applicant to apply to the relevant administrative agency
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When the drug regulatory department accepts or refuses to accept the medical device registration application, it shall issue a notice of acceptance or non-acceptance affixed with the special seal of the administrative agency and dated
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After the medical device registration application is accepted, if the applicant is required to pay fees, the applicant shall pay the fees as required
.
If the applicant fails to pay the fees within the prescribed time limit, it shall be deemed that the applicant has withdrawn the application voluntarily, and the drug regulatory authority shall terminate its registration procedure
.
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If the applicant fails to pay the fees within the prescribed time limit, it shall be deemed that the applicant has withdrawn the application voluntarily, and the drug regulatory authority shall terminate its registration procedure
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The product name, model, specification, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc.
stated in the registration certificate are the items that need to be registered for change as specified in the preceding paragraph
.
The name and domicile of the registrant, the name and domicile of the agent, etc.
, are matters that need to be filed as prescribed in the preceding paragraph
.
If the domestic medical device production address is changed, the registrant shall file for the record after handling the corresponding production license change
.
stated in the registration certificate are the items that need to be registered for change as specified in the preceding paragraph
.
The name and domicile of the registrant, the name and domicile of the agent, etc.
, are matters that need to be filed as prescribed in the preceding paragraph
.
If the domestic medical device production address is changed, the registrant shall file for the record after handling the corresponding production license change
.
In the event of other changes, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug regulatory authority in accordance with regulations
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Article 80 With regard to the application for change registration, the technical review agency shall focus on the review of the changed part, and form an review opinion on whether the product after the change is safe, effective, and controllable in quality
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In the technical review of the application for change registration, if it is deemed necessary to verify the quality management system, the drug regulatory authority shall organize the quality management system verification
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Article 81 The medical device modification registration document is used in combination with the original medical device registration certificate, and the expiration date of the validity period is the same as that of the original medical device registration certificate
.
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Section II continued registration
Article 82 If the medical device registration certificate expires and needs to be renewed, the registrant shall apply to the original registration department for registration renewal 6 months before the expiration of the medical device registration certificate, and submit the application materials in accordance with relevant requirements
.
.
Except for the circumstances stipulated in Article 83 of these Measures, the drug regulatory authority that receives an application for renewal shall make a decision to approve the renewal before the expiration of the medical device registration certificate
.
If no decision is made within the time limit, it shall be deemed that the renewal is approved
.
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If no decision is made within the time limit, it shall be deemed that the renewal is approved
.
Article 83 In any of the following circumstances, registration shall not be renewed:
(1) Failure to file an application for renewal of registration within the prescribed time limit;
(2) The new mandatory standards for medical devices are issued and implemented, and the medical devices applying for renewal of registration cannot meet the new requirements;
(3) For medical devices with conditional approval, the items specified in the medical device registration certificate have not been completed within the prescribed time limit
.
.
Article 84 If the approval time for renewal of registration is within the validity period of the original registration certificate, the start date of the validity period of the renewal registration certificate shall be the day following the expiration date of the original registration certificate; if the approval time is not within the validity period of the original registration certificate, the registration of the renewal registration shall be renewed The starting date of the validity period of the certificate is the date of approval to renew the registration
.
.
Article 85 The procedures for the acceptance and approval of medical device modification registration applications and renewal registration applications, which are not provided for in this chapter, shall be subject to the relevant provisions of Chapter 3 of these Measures
.
.
Chapter VI Medical Device Filing
Article 86 Prior to the production of Class I medical devices, product filings shall be made
.
.
Article 87 For the filing of medical devices, the filing person shall submit the filing materials to the drug regulatory authority and obtain the filing number in accordance with the Regulations on the Supervision and Administration of Medical Devices
.
.
Article 88: For medical devices that have been filed, if the content and technical requirements of the product on the filed information sheet are changed, the filer shall change the file to the original filed department and submit an explanation of the change and related documents
.
The drug supervision and administration department shall post the changes in the record information
.
.
The drug supervision and administration department shall post the changes in the record information
.
Article 89 If the registered medical device management category is adjusted to the second or third category of medical devices, it shall apply for registration in accordance with the provisions of these Measures
.
.
Chapter VII of working hours
Article 90 The time limit specified in these Measures is the maximum time for the acceptance, technical review, verification, and approval of medical device registration
.
The working time limit for the special registration procedure shall be implemented in accordance with the relevant regulations of the special registration procedure
.
.
The working time limit for the special registration procedure shall be implemented in accordance with the relevant regulations of the special registration procedure
.
Professional technical institutions such as the National Bureau’s Device Evaluation Center shall clarify the working procedures and time limits of their units and announce them to the public
.
.
Article 91 After receiving the medical device registration application and clinical trial application, the drug regulatory authority shall forward the application materials to the technical review agency within 3 days from the date of acceptance
.
The acceptance requirements for clinical trial applications shall apply to the provisions of Article 53 of these Measures
.
.
The acceptance requirements for clinical trial applications shall apply to the provisions of Article 53 of these Measures
.
Article 92 The time limit for the technical review of medical device registration shall be implemented in accordance with the following provisions:
(1) The technical review time limit for the medical device clinical trial application is 60 days, and the technical review time limit after the application materials are supplemented and corrected is 40 days;
(2) The technical review time limit for the second-class medical device registration application, registration modification application, and registration renewal application is 60 days, and the technical review time limit after the application materials are supplemented and corrected is 60 days;
(3) The technical review time limit for the third-class medical device registration application, registration modification application, and registration renewal application is 90 days, and the technical review time limit for the application materials after supplementation is 60 days
.
.
Article 93 The time limit for the verification of the domestic Class III medical device quality management system shall be implemented in accordance with the following regulations:
(1) The National Bureau’s Device Evaluation Center shall notify the relevant provinces, autonomous regions, and municipalities’ drug regulatory authorities to initiate verification within 10 days after the medical device registration application is accepted;
(2) In principle, the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall complete the inspection within 30 days after receiving the inspection notice, and feed back relevant materials such as the inspection results and inspection results to the National Bureau of Device Evaluation Center
.
.
Article 94 The drug regulatory authority that accepts the registration application shall make a decision within 20 days from the date of receiving the review opinion
.
.
Article 95 The drug supervision and administration department shall issue and serve the relevant administrative license within 10 days from the date of the medical device registration approval decision
.
.
Article 96 If it is necessary to extend the time limit due to special circumstances such as product characteristics and technical review and verification work, the extended time limit shall not exceed one-half of the original time limit.
After the medical device technical review, verification and other relevant technical institutions After the person in charge approves, the technical agency that extended the time limit shall notify the applicant in writing and notify other relevant technical agencies
.
After the medical device technical review, verification and other relevant technical institutions After the person in charge approves, the technical agency that extended the time limit shall notify the applicant in writing and notify other relevant technical agencies
.
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Article 4 The registration of in vitro diagnostic reagents means that the applicant for in vitro diagnostic reagent registration (hereinafter referred to as the applicant) submits an application for in vitro diagnostic reagent registration in accordance with legal procedures and requirements.
Review of validity and quality controllability, etc.
, to decide whether to approve the activities they have applied for
.
Review of validity and quality controllability, etc.
, to decide whether to approve the activities they have applied for
.
The filing of in vitro diagnostic reagents refers to the in vitro diagnostic reagent filing (hereinafter referred to as the filing person) in accordance with legal procedures and requirements to submit filing materials to the drug regulatory authority, and the drug regulatory agency to file the submitted filing materials for review
.
.
Article 5 The State Drug Administration is in charge of the national in vitro diagnostic reagent registration and filing management work, is responsible for establishing the in vitro diagnostic reagent registration and filing management system, and organizing the domestic third category and imported second and third category in vitro diagnostic reagents in accordance with the law.
Review and approve, import the first type of in vitro diagnostic reagents for the record and related supervision and management, and supervise and guide the registration and record of local in vitro diagnostic reagents
.
Review and approve, import the first type of in vitro diagnostic reagents for the record and related supervision and management, and supervise and guide the registration and record of local in vitro diagnostic reagents
.
Article 6 The Medical Device Technical Evaluation Center of the State Drug Administration (hereinafter referred to as the National Bureau of Medical Device Evaluation Center) is responsible for the registration application, change registration application, and renewal of domestic category III and imported category II and III in-vitro diagnostic reagent products Application and other technical review work
.
.
Medical Device Standards Management Center of the State Drug Administration, China Food and Drug Administration, Food and Drug Inspection and Inspection Center of the State Drug Administration (hereinafter referred to as the National Bureau of Inspection and Inspection Center), the Drug Evaluation Center of the State Drug Administration, and the National Drug Administration Administrative Affairs Acceptance Service and Complaint Report Center, National Medical Products Administration Information Center and other professional technical institutions, according to their responsibilities, undertake the standard management, classification and definition, inspection, verification, and monitoring of in vitro diagnostic reagents required for the supervision and management of in vitro diagnostic reagents.
Work related to evaluation, certificate preparation and delivery, and corresponding informatization construction and management
.
Work related to evaluation, certificate preparation and delivery, and corresponding informatization construction and management
.
Article 7 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the registration of the following in vitro diagnostic reagents in their respective administrative areas:
(1) Domestic Class II in-vitro diagnostic reagent registration review and approval;
(2) Verification of the quality management system of Class II and Class III in-vitro diagnostic reagents in China;
(3) Organizing medical device clinical trial institutions and the supervision and management of clinical trials in accordance with the law;
(4) Supervision and guidance for the filing of Class I in vitro diagnostic reagents within the territory of the department responsible for drug supervision and management of the city divided into districts
.
.
The medical device professional technical institutions established or designated by the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the technical review, inspection, verification, monitoring and evaluation required for the implementation of the supervision and management of in vitro diagnostic reagents
.
.
The department in charge of drug supervision and administration at the city level divided into districts shall be responsible for the filing and management of domestic first-class in vitro diagnostic reagent products
.
.
Article 8 The registration and filing of in vitro diagnostic reagents shall follow the principles of law, science, openness, fairness and justice
.
.
Article 9 The first category of in vitro diagnostic reagents shall be subject to product filing management
.
The second and third types of in vitro diagnostic reagents are subject to product registration management
.
.
The second and third types of in vitro diagnostic reagents are subject to product registration management
.
For the filing of domestic first-class in vitro diagnostic reagents, the filing person shall submit the filing materials to the department responsible for drug supervision and management of the city divided into districts
.
.
The second category of in-vitro diagnostic reagents in the country shall be reviewed by the drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government, and a medical device registration certificate will be issued after approval
.
.
The third category of in-vitro diagnostic reagents in China will be reviewed by the State Drug Administration, and a medical device registration certificate will be issued after approval
.
.
For the import of Class I in-vitro diagnostic reagents for filing, the filing person shall submit the filing materials to the State Drug Administration
.
.
Imported Class II and Class III in-vitro diagnostic reagents will be reviewed by the State Drug Administration, and a medical device registration certificate will be issued after approval
.
.
Article 10 The registrant and recorder of in-vitro diagnostic reagents shall strengthen the quality management of the entire life-cycle of in-vitro diagnostic reagents, and shall be responsible for the safety, effectiveness and quality controllability of in-vitro diagnostic reagents in the whole process of development, production, operation and use.
Responsibility
.
Responsibility
.
Article 11 The State Drug Administration shall give priority approval to clinically urgently needed in vitro diagnostic reagents, and implement special approval for innovative in vitro diagnostic reagents
.
Encourage the research and innovation of in vitro diagnostic reagents and promote the high-quality development of the medical device industry
.
.
Encourage the research and innovation of in vitro diagnostic reagents and promote the high-quality development of the medical device industry
.
Article 12 The National Medical Products Administration shall establish and improve in vitro diagnostic reagent standards, technical guidelines and other systems in accordance with the law, regulate in vitro diagnostic reagent technology review and quality management system verification, and guide and serve in vitro diagnostic reagent research and development and registration applications
.
.
Article 13 The drug supervision and administration department shall promptly disclose the relevant information on the registration and filing of in vitro diagnostic reagents in accordance with the law.
Applicants can inquire about the progress and results of the examination and approval, and the public can consult the results of the examination and approval
.
Applicants can inquire about the progress and results of the examination and approval, and the public can consult the results of the examination and approval
.
Without the consent of the applicant, the drug regulatory authority, professional technical institutions and their staff, experts participating in the review and other personnel shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant or the filing party, as otherwise provided by law or Except those involving national security and major social public interests
.
.
Chapter II Basic Requirements
Article 14 The registration and filing of in-vitro diagnostic reagents shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of the safety and performance of in-vitro diagnostic reagents, and refer to relevant technical guidelines to prove that the registered and filed in-vitro diagnostic reagents are safe, Effective, quality controllable, to ensure that the information is true, accurate, complete and traceable
.
.
Article 15 The applicant and filing person shall be an enterprise or research institution that can bear corresponding legal responsibilities
.
.
Overseas applicants and filing parties shall designate corporate legal persons in China as their agents to handle the registration and filing of relevant in vitro diagnostic reagents
.
The agent shall assist the registrant and the filing party in fulfilling the obligations stipulated in Article 20, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices in accordance with the law, and assist the overseas registrant and filing party in fulfilling the corresponding legal responsibilities
.
.
The agent shall assist the registrant and the filing party in fulfilling the obligations stipulated in Article 20, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices in accordance with the law, and assist the overseas registrant and filing party in fulfilling the corresponding legal responsibilities
.
Article 16 Applicants and record holders shall establish a quality management system related to product development and production, and maintain effective operation
.
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Article 48 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall carry out quality management system verification in accordance with the requirements of the medical device production quality management specifications, focusing on whether the applicant has established a quality compatible with the product in accordance with the requirements of the medical device production quality management specifications The management system, as well as the design and development, production management, quality control and other content related to product development and production are checked
.
.
During the verification process, the authenticity of the inspection products and clinical trial products should be verified at the same time, with emphasis on reviewing the relevant records of the design and development process, as well as the relevant records of the production process of the inspection products and clinical trial products
.
.
When submitting a self-inspection report, the applicant, the filing person or the trustee institution shall conduct key inspections on the inspection capabilities and inspection results during the development process
.
.
Article 49 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government may conduct quality management system verification through document review or on-site inspection
.
According to the applicant's specific situation, supervision and inspection, the product applied for registration this time and the previous inspection product production conditions and process comparison, etc.
, determine whether on-site inspection and inspection content, to avoid repeated inspections
.
.
According to the applicant's specific situation, supervision and inspection, the product applied for registration this time and the previous inspection product production conditions and process comparison, etc.
, determine whether on-site inspection and inspection content, to avoid repeated inspections
.
Article 50 When the National Bureau’s Device Review Center conducts technical review of imported Type II and Type III in-vitro diagnostic reagents, if it considers that it is necessary to conduct quality management system verification, it shall notify the National Bureau of Review and Inspection Center to conduct verification in accordance with relevant requirements
.
.
Section 4 Product Registration
Article 51 The applicant shall submit an application for the registration of in vitro diagnostic reagents after completing the safety and effectiveness studies supporting the registration of in-vitro diagnostic reagents and be prepared for the verification of the quality management system, and apply for the registration of in-vitro diagnostic reagents in accordance with relevant requirements.
Submit the following registration application materials to the drug supervision and administration department through other channels:
Submit the following registration application materials to the drug supervision and administration department through other channels:
(1) Product risk analysis data;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation data;
(5) Product manuals and label samples;
(6) Quality management system documents related to product development and production;
(7) Other materials required to prove that the product is safe and effective
.
.
Article 52 After receiving the application, the drug supervision and administration department shall review the application materials and deal with it separately according to the following conditions:
(1) The application matters are within the scope of the administrative agency's powers, and the application materials are complete and meet the formal review requirements, it will be accepted;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(3) If the application materials are incomplete or do not conform to the legal form, the applicant shall be notified on the spot or within 5 days of all the contents that need to be supplemented and corrected at one time.
If the application is not notified within the time limit, the application shall be accepted as of the day when the application materials are received;
If the application is not notified within the time limit, the application shall be accepted as of the day when the application materials are received;
(4) If the application matters are not within the scope of the administrative agency's powers in accordance with the law, it shall immediately make a decision not to accept the application, and notify the applicant to apply to the relevant administrative agency
.
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When the drug regulatory department accepts or refuses to accept an application for registration of in vitro diagnostic reagents, it shall issue a notice of acceptance or non-acceptance affixed with the special seal of the administrative agency and dated
.
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After the in-vitro diagnostic reagent registration application is accepted, if the applicant is required to pay fees, the applicant shall pay the fees as required
.
If the applicant fails to pay the fees within the prescribed time limit, it shall be deemed that the applicant has withdrawn the application voluntarily, and the drug regulatory authority shall terminate its registration procedure
.
.
If the applicant fails to pay the fees within the prescribed time limit, it shall be deemed that the applicant has withdrawn the application voluntarily, and the drug regulatory authority shall terminate its registration procedure
.
Article 53 If the applicant needs to supplement and correct the materials during the technical review process, the technical review agency shall notify all the contents that need to be supplemented and corrected at one time
.
The applicant shall provide supplementary materials in one time in accordance with the requirements of the supplementary notice within one year after receiving the notice of supplementary correction; after receiving the supplementary materials, the technical review agency shall complete the technical review within the prescribed time limit
.
.
The applicant shall provide supplementary materials in one time in accordance with the requirements of the supplementary notice within one year after receiving the notice of supplementary correction; after receiving the supplementary materials, the technical review agency shall complete the technical review within the prescribed time limit
.
If the applicant disagrees with the content of the notice of supplementation and correction, he may submit a written opinion to the corresponding technical review agency, explain the reason and provide corresponding technical support materials
.
.
If the applicant fails to submit supplementary materials within the time limit, the technical review shall be terminated, and the drug regulatory authority shall make a decision not to approve the registration
.
.
Article 54 For an accepted registration application, the applicant may apply to the drug regulatory authority that accepted the application to withdraw the registration application and related materials, and explain the reasons before the administrative licensing decision is made
.
If it agrees to withdraw the application, the drug regulatory authority shall terminate its registration procedure
.
.
If it agrees to withdraw the application, the drug regulatory authority shall terminate its registration procedure
.
In the process of review, verification, and approval, if any illegal act is found to be suspected of concealing the truth or providing false information, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the registration application
.
.
Article 55 For the accepted registration application, if there is evidence showing that the registration application materials may be false, the drug regulatory authority may suspend the review and approval
.
After verification, continue to review or make a decision not to grant registration based on the verification conclusion
.
.
After verification, continue to review or make a decision not to grant registration based on the verification conclusion
.
Article 56 During the review period of the in-vitro diagnostic reagent registration application, if the review conclusion is to be rejected, the technical review agency shall inform the applicant of the reason for the disapproval, and the applicant can submit a request to the technical review agency within 15 days Objection, the content of the objection is limited to the original application items and original application materials
.
The technical review agency conducts a comprehensive evaluation based on the applicant’s objections and gives feedback to the applicant
.
The objection processing time is not included in the review time limit
.
.
The technical review agency conducts a comprehensive evaluation based on the applicant’s objections and gives feedback to the applicant
.
The objection processing time is not included in the review time limit
.
Article 57 The drug regulatory authority that accepts the registration application shall make a decision on whether to approve or not after the technical review is completed
.
For those that meet the requirements of safety, effectiveness, and controllable quality, registration is approved and a medical device registration certificate is issued, and the approved product technical requirements and product manuals are issued to the applicant in the form of attachments
.
If the registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law
.
.
For those that meet the requirements of safety, effectiveness, and controllable quality, registration is approved and a medical device registration certificate is issued, and the approved product technical requirements and product manuals are issued to the applicant in the form of attachments
.
If the registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law
.
The medical device registration certificate is valid for 5 years
.
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Article 58 For the accepted registration application, if one of the following situations occurs, the drug regulatory authority shall make a decision not to approve the registration and notify the applicant:
(1) The applicant's research on the safety, effectiveness, and quality controllability of the in-vitro diagnostic reagents to be sold on the market and the results cannot prove that the product is safe, effective, and quality controllable;
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(1) The Device Evaluation Center of the State Administration shall notify the relevant provinces, autonomous regions, and municipalities' drug regulatory authorities to initiate the verification within 10 days after the in-vitro diagnostic reagent registration application is accepted;
(2) In principle, the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall complete the inspection within 30 days after receiving the inspection notice, and feed back relevant materials such as the inspection results and inspection results to the National Bureau of Device Evaluation Center
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Article 94 The drug regulatory authority that accepts the registration application shall make a decision within 20 days from the date of receiving the review opinion
.
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Article 95 The drug regulatory authority shall issue and serve the relevant administrative license within 10 days from the date of making the decision on the registration and approval of in vitro diagnostic reagents
.
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Article 96 If it is necessary to extend the time limit due to special circumstances such as product characteristics and technical review and verification work, the extended time limit shall not exceed one-half of the original time limit.
After the medical device technical review, verification and other relevant technical institutions After the person in charge approves, the technical agency that extended the time limit shall notify the applicant in writing and notify other relevant technical agencies
.
After the medical device technical review, verification and other relevant technical institutions After the person in charge approves, the technical agency that extended the time limit shall notify the applicant in writing and notify other relevant technical agencies
.
Article 97 The original issuing authority shall reissue the medical device registration certificate within 20 days from the date of receipt of the application for reissue of the medical device registration certificate
.
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Article 98 The following time is not included in the relevant working hours:
(1) The time taken by the applicant for supplementing materials, rectification after verification, etc.
;
;
(2) The time for verification is delayed due to the applicant;
(3) The time required for external expert consultation, expert consultation meetings, and joint review with the drug review agency;
(4) If the review, review and approval procedures are suspended in accordance with regulations, the time taken during the suspension of the review, review and approval procedures;
(5) The time taken for the verification of the quality management system
.
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Article 99 The time limit specified in these Measures is calculated based on working days
.
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Chapter 8 Supervision and Administration
Article 100 The drug regulatory authority shall strengthen the supervision and inspection of in vitro diagnostic reagent development activities, and may conduct extended inspections of units and individuals that provide products or services for the development of in vitro diagnostic reagents.
Relevant units and individuals shall cooperate and provide relevant Documents and materials shall not be rejected, concealed, or obstructed
.
Relevant units and individuals shall cooperate and provide relevant Documents and materials shall not be rejected, concealed, or obstructed
.
Article 101 The State Drug Administration establishes and implements a unique identification system for medical devices step by step.
Applicants and recorders shall submit information related to unique identification in accordance with relevant regulations to ensure that the data is true, accurate, and traceable
.
Applicants and recorders shall submit information related to unique identification in accordance with relevant regulations to ensure that the data is true, accurate, and traceable
.
Article 102 The State Drug Administration shall promptly notify the agent's information to the drug regulatory department of the province, autonomous region, or municipality where the agent is located
.
The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government organize daily supervision and management of agents in their respective administrative regions
.
.
The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government organize daily supervision and management of agents in their respective administrative regions
.
Article 103 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize post-filing supervision and inspection of clinical trial institutions that have been filed in their respective administrative regions based on the filing status of medical device clinical trial institutions
.
For newly filed medical device clinical trial institutions, supervision and inspection shall be carried out within 60 days after the filing
.
.
For newly filed medical device clinical trial institutions, supervision and inspection shall be carried out within 60 days after the filing
.
The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize daily supervision and inspection of the compliance of medical device clinical trials by medical device clinical trial institutions in their respective administrative regions, and supervise their continued compliance with the prescribed requirements
.
The State Drug Administration shall supervise and inspect medical device clinical trial institutions as needed
.
.
The State Drug Administration shall supervise and inspect medical device clinical trial institutions as needed
.
Article 104 Where the drug regulatory authority deems it necessary, it may conduct on-site inspections of the authenticity, accuracy, completeness, standardization, and traceability of clinical trials
.
.
Article 105 If the drug regulatory department responsible for the filing of Class I in-vitro diagnostic reagent products finds irregularities in the filing materials during the post-filing supervision, it shall order the filing person to make corrections within a time limit
.
.
Article 106 Where the drug regulatory authority fails to discover the systemic and regional risks of in vitro diagnostic reagent registration management within its administrative area in time, or fails to eliminate the systemic or regional risks of in vitro diagnostic reagent registration management within its administrative area in time, The higher-level drug supervision and administration department may make an interview with the main person in charge of the lower-level drug supervision and administration department
.
.
Chapter IX Legal Liability
Article 107 Anyone who violates the provisions of Article 78 of these Measures and fails to file the changes as required shall be ordered to make corrections within a time limit; if the corrections are not made within the time limit, a fine of 10,000 yuan to 30,000 yuan shall be imposed
.
.
Article 108 Those who fail to comply with the clinical trial quality management norms when conducting clinical trials of in vitro diagnostic reagents shall be punished in accordance with Article 94 of the Regulations on the Supervision and Administration of Medical Devices
.
.
Article 109 If a medical device technical review agency fails to perform its duties in accordance with the provisions of these Measures, causing major errors in the review work, the department responsible for drug supervision and administration shall order corrections, notify criticisms, and give warnings; if serious consequences are caused, The legal representative, main responsible person, directly responsible person in charge, and other responsible persons of the illegal unit shall be punished in accordance with the law
.
.
Article 110 If the staff of the department responsible for drug supervision and management violates the regulations, abuses their power, neglects their duties, or engages in malpractices for personal gains, they shall be punished in accordance with the law
.
.
Chapter 10 Supplementary Provisions
Article 111 named in vitro diagnostic reagents should follow the following principles:
The product name of in vitro diagnostic reagents generally consists of three parts
.
The first part: the name of the substance to be tested; the second part: use, such as assay kits, quality control products, etc.
; the third part: methods or principles, such as magnetic particle chemiluminescence immunoassay, fluorescence PCR, fluorescence in situ hybridization Law, etc.
, this section should be listed in brackets
.
.
The first part: the name of the substance to be tested; the second part: use, such as assay kits, quality control products, etc.
; the third part: methods or principles, such as magnetic particle chemiluminescence immunoassay, fluorescence PCR, fluorescence in situ hybridization Law, etc.
, this section should be listed in brackets
.
If the test substance has many components or other special circumstances, the product-related indication name or other alternative names can be used
.
.
The first category of products, calibrators, and quality control products are named according to their intended use
.
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Without the consent of the applicant, the drug regulatory authority, professional technical institutions and their staff, experts participating in the review and other personnel shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant or the filing party, as otherwise provided by law or Except those involving national security and major social public interests
.
.
Chapter II Basic Requirements
Article 13 The registration and filing of medical devices shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of medical device safety and performance, and refer to relevant technical guidelines to prove that the registered and filing medical devices are safe, effective, and of acceptable quality.
To ensure that the information in the whole process is true, accurate, complete and traceable
.
To ensure that the information in the whole process is true, accurate, complete and traceable
.
Article 14 The applicant and the filing person shall be an enterprise or research institution that can bear corresponding legal responsibilities
.
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Overseas applicants filing shall specify the territory of China as a corporate agent who, for the relevant medical device registration, filing matters
.
The agent shall assist the registrant and the filing party in fulfilling the obligations stipulated in Article 20, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices in accordance with the law, and assist the overseas registrant and filing party in fulfilling the corresponding legal responsibilities
.
.
The agent shall assist the registrant and the filing party in fulfilling the obligations stipulated in Article 20, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices in accordance with the law, and assist the overseas registrant and filing party in fulfilling the corresponding legal responsibilities
.
Article 15 The applicant and the filing party shall establish a quality management system suitable for the product and maintain effective operation
.
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Article 16 Personnel handling medical device registration and filing matters shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and related regulations of registration management of medical device registration and filing management
.
.
Article 17 When applying for registration or filing, relevant materials shall be submitted in accordance with the relevant registration and filing requirements of the State Drug Administration, and the applicant and filing person shall be responsible for the authenticity of the materials
.
.
The registration and filing materials shall be in Chinese
.
If the translation is based on foreign language materials, the original text shall be provided at the same time
.
When citing unpublished documents and materials, documents permitted to be used by the owner of the materials shall be provided
.
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If the translation is based on foreign language materials, the original text shall be provided at the same time
.
When citing unpublished documents and materials, documents permitted to be used by the owner of the materials shall be provided
.
Article 18 To apply for the registration of imported medical devices and to handle the filing of imported medical devices, the applicant, the filing person, or the competent authority of the country (region) where the place of production is located shall be submitted with a certification document that permits the medical device to be sold on the market
.
.
If the applicant, the place of registration or the country (region) where the place of production is located does not manage the product as a medical device, the applicant and the place of record must provide relevant documents, including the country (region) where the place of registration or place of production is located to allow the product to be marketed Proof of sales
.
.
Innovative medical devices that have not been marketed in the country (region) where the applicant or the recorder is registered or where the place of production is located do not need to submit relevant documents
.
.
Article 19 Medical devices shall comply with applicable mandatory standards
.
If the product structure characteristics, intended use, usage method, etc.
are inconsistent with the scope of application of the mandatory standards, the applicant and filing party shall provide an explanation on the non-applicability of the mandatory standards and provide relevant materials
.
.
If the product structure characteristics, intended use, usage method, etc.
are inconsistent with the scope of application of the mandatory standards, the applicant and filing party shall provide an explanation on the non-applicability of the mandatory standards and provide relevant materials
.
If there are no mandatory standards, applicants and recorders are encouraged to adopt recommended standards
.
.
Article 20 The registration and filing of medical devices shall follow the relevant requirements of the medical device classification rules and classification catalogs
.
.
Article 21 The drug regulatory department continues to promote the reform of the review, review and approval system, strengthen scientific research on medical device supervision, and establish a medical device registration management technology system based on technical review and evaluation, and supported by verification, inspection, monitoring and evaluation.
Optimize the review, review and approval process, improve review, review and approval capabilities, and improve the quality and efficiency of review, review and approval
.
Optimize the review, review and approval process, improve review, review and approval capabilities, and improve the quality and efficiency of review, review and approval
.
Article 22 The medical device professional technical institution shall establish a sound communication system, clarify the form and content of communication, and organize communication with applicants according to work needs
.
.
Article 23 The medical device professional technical institution shall establish an expert consultation system according to work needs, listen to expert opinions on major issues in the process of review, verification, and inspection, and give full play to the technical support role of experts
.
.
Chapter III Medical Device Registration
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Article 54 If the applicant needs to supplement and correct the materials during the technical review process, the technical review agency shall notify all the contents that need to be supplemented and corrected at one time
.
The applicant shall provide supplementary materials in one time in accordance with the requirements of the supplementary notice within one year after receiving the notice of supplementary correction; after receiving the supplementary materials, the technical review agency shall complete the technical review within the prescribed time limit
.
.
The applicant shall provide supplementary materials in one time in accordance with the requirements of the supplementary notice within one year after receiving the notice of supplementary correction; after receiving the supplementary materials, the technical review agency shall complete the technical review within the prescribed time limit
.
If the applicant disagrees with the content of the notice of supplementation and correction, he may submit a written opinion to the corresponding technical review agency, explain the reason and provide corresponding technical support materials
.
.
If the applicant fails to submit supplementary materials within the time limit, the technical review shall be terminated, and the drug regulatory authority shall make a decision not to approve the registration
.
.
Article 55 For the accepted registration application, the applicant may apply to the drug regulatory authority that accepted the application to withdraw the registration application and related materials, and explain the reasons before the administrative licensing decision is made
.
If it agrees to withdraw the application, the drug regulatory authority shall terminate its registration procedure
.
.
If it agrees to withdraw the application, the drug regulatory authority shall terminate its registration procedure
.
In the process of review, verification, and approval, if any illegal act is found to be suspected of concealing the truth or providing false information, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the medical device registration application
.
.
Article 56 For the accepted registration application, if there is evidence showing that the registration application materials may be false, the drug regulatory authority may suspend the review and approval
.
After verification, continue to review or make a decision not to grant registration based on the verification conclusion
.
.
After verification, continue to review or make a decision not to grant registration based on the verification conclusion
.
Article 57 During the review of a medical device registration application, if a review conclusion that is to be rejected is to be made, the technical review agency shall inform the applicant of the reason for the rejection, and the applicant may raise an objection to the technical review agency within 15 days , The content of the objection is limited to the original application items and original application materials
.
The technical review agency conducts a comprehensive evaluation based on the applicant’s objections and gives feedback to the applicant
.
The objection processing time is not included in the review time limit
.
.
The technical review agency conducts a comprehensive evaluation based on the applicant’s objections and gives feedback to the applicant
.
The objection processing time is not included in the review time limit
.
Article 58 The drug regulatory authority that accepts the registration application shall make a decision on whether to approve or not after the technical review is completed
.
For those that meet the requirements of safety, effectiveness, and quality control, registration is approved and a medical device registration certificate is issued, and the approved product technical requirements are issued to the applicant in the form of an attachment
.
If the registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law
.
.
For those that meet the requirements of safety, effectiveness, and quality control, registration is approved and a medical device registration certificate is issued, and the approved product technical requirements are issued to the applicant in the form of an attachment
.
If the registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law
.
The medical device registration certificate is valid for 5 years
.
.
Article 59 For the accepted registration application, if one of the following situations occurs, the drug regulatory authority shall make a decision not to approve the registration and notify the applicant:
(1) The applicant's research on the safety, effectiveness, and quality controllability of the medical device to be sold on the market and its results cannot prove that the product is safe, effective, and quality controllable;
(2) The quality management system fails to pass the verification, and the applicant refuses to accept the on-site inspection of the quality management system;
(3) The registration application materials are false;
(4) The contents of the registration application materials are confused and contradictory, and the contents of the registration application materials are obviously inconsistent with the application items, and the product cannot be proved to be safe, effective, and controllable in quality;
(5) Other circumstances where registration is not granted
.
.
Article 60: For matters that laws, regulations, and rules require a hearing for the implementation of administrative licensing, or other major administrative licensing matters that involve public interest that the drug regulatory authority considers to require a hearing, the drug regulatory authority shall make an announcement to the public and hold a hearing
.
If the medical device registration application directly involves the significant relationship of interest between the applicant and others, the drug regulatory authority shall inform the applicant and interested parties of the right to request a hearing before making an administrative licensing decision
.
.
If the medical device registration application directly involves the significant relationship of interest between the applicant and others, the drug regulatory authority shall inform the applicant and interested parties of the right to request a hearing before making an administrative licensing decision
.
Article 61 For medical devices that are urgently needed for the treatment of rare diseases, serious life-threatening diseases without effective treatment, and response to public health events, the drug regulatory authority may make a conditional approval decision and register the medical device.
The certificate specifies the validity period, the research work that needs to be completed after the listing, and the time limit for completion and other related matters
.
The certificate specifies the validity period, the research work that needs to be completed after the listing, and the time limit for completion and other related matters
.
Article 62 For medical devices approved with conditions, the registrant shall collect data on benefits and risks after the medical devices are on the market, continue to monitor and evaluate the benefits and risks of the products, take effective measures to actively manage and control risks, and stipulate Complete the research and submit relevant materials as required within the time limit
.
.
Article 63 For conditionally approved medical devices, if the registrant fails to complete the research as required or cannot prove that the benefits are greater than the risks, the registrant shall promptly apply for the cancellation of the medical device registration certificate, and the drug regulatory authority may cancel it in accordance with the law.
Medical device registration certificate
.
Medical device registration certificate
.
Article 64 For newly developed medical devices that have not yet been included in the classification catalog, the applicant may directly apply for the registration of the third category of medical device products, or may determine the product category according to the classification rules and apply to the State Drug Administration for category confirmation.
, Apply for product registration or product filing
.
, Apply for product registration or product filing
.
For directly applying for the registration of Class III medical devices, the State Drug Administration shall determine the category according to the degree of risk
.
If a domestic medical device is determined to be in the second or first category, the applicant shall be notified to apply for registration or record filing with the corresponding drug regulatory authority
.
.
If a domestic medical device is determined to be in the second or first category, the applicant shall be notified to apply for registration or record filing with the corresponding drug regulatory authority
.
Article 65 If the management category of the registered medical device is adjusted from the high category to the low category, the medical device registration certificate shall continue to be valid within the validity period
.
If the validity period expires and needs to be renewed, the medical device registration certificate shall be applied to the corresponding drug regulatory authority for renewal of registration or filing in accordance with the adjusted category 6 months before the expiration of the validity period of the medical device registration certificate
.
.
If the validity period expires and needs to be renewed, the medical device registration certificate shall be applied to the corresponding drug regulatory authority for renewal of registration or filing in accordance with the adjusted category 6 months before the expiration of the validity period of the medical device registration certificate
.
If the medical device management category is adjusted from a low category to a high category, the registrant shall apply to the corresponding drug regulatory authority for registration in accordance with the changed category
.
The State Drug Administration shall stipulate the time limit for completing the adjustment in the notice of adjustment of the management category
.
.
The State Drug Administration shall stipulate the time limit for completing the adjustment in the notice of adjustment of the management category
.
Article 66 If the medical device registration certificate and its attachments are lost or damaged, the registrant shall apply to the original issuing authority for reissuing, and the original issuing authority shall reissue it after verification
.
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Article 97 The original issuing authority shall reissue the medical device registration certificate within 20 days from the date of receipt of the application for reissue of the medical device registration certificate
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Article 98 The following time is not included in the relevant working hours:
(1) The time taken by the applicant for supplementing materials, rectification after verification, etc.
;
;
(2) The time for verification is delayed due to the applicant;
(3) Consultation with external experts, holding expert consultation meetings, and the time required for joint review of drug-device combination products with drug review agencies;
(4) If the review, review and approval procedures are suspended in accordance with regulations, the time taken during the suspension of the review, review and approval procedures;
(5) The time taken for the verification of the quality management system
.
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Article 99 The time limit specified in these Measures is calculated based on working days
.
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Chapter 8 Supervision and Administration
Article 100 The drug regulatory authority shall strengthen the supervision and inspection of medical device research and development activities.
When necessary, it may conduct extended inspections on units and individuals that provide products or services for medical device research and development.
Relevant units and individuals shall cooperate and provide relevant documents.
And materials, no rejection, concealment, or obstruction is allowed
.
When necessary, it may conduct extended inspections on units and individuals that provide products or services for medical device research and development.
Relevant units and individuals shall cooperate and provide relevant documents.
And materials, no rejection, concealment, or obstruction is allowed
.
Article 101 The State Drug Administration establishes and implements a unique identification system for medical devices step by step.
Applicants and recorders shall submit information related to unique identification in accordance with relevant regulations to ensure that the data is true, accurate, and traceable
.
Applicants and recorders shall submit information related to unique identification in accordance with relevant regulations to ensure that the data is true, accurate, and traceable
.
Article 102 The State Drug Administration shall promptly notify the agent's information to the drug regulatory department of the province, autonomous region, or municipality where the agent is located
.
The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government organize daily supervision and management of agents in their respective administrative regions
.
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The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government organize daily supervision and management of agents in their respective administrative regions
.
Article 103 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize post-filing supervision and inspection of clinical trial institutions that have been filed in their respective administrative regions based on the filing status of medical device clinical trial institutions
.
For newly filed medical device clinical trial institutions, supervision and inspection shall be carried out within 60 days after the filing
.
.
For newly filed medical device clinical trial institutions, supervision and inspection shall be carried out within 60 days after the filing
.
The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize daily supervision and inspection of the compliance of medical device clinical trials by medical device clinical trial institutions in their respective administrative regions, and supervise their continued compliance with the prescribed requirements
.
The State Drug Administration shall supervise and inspect medical device clinical trial institutions as needed
.
.
The State Drug Administration shall supervise and inspect medical device clinical trial institutions as needed
.
Article 104 Where the drug regulatory authority deems it necessary, it may conduct on-site inspections of the authenticity, accuracy, completeness, standardization, and traceability of clinical trials
.
.
Article 105 If the drug regulatory authority responsible for the filing of Class I medical device products finds irregularities in the filing materials during the post-filing supervision, it shall order the filing person to make corrections within a time limit
.
.
Article 106 If the drug supervision and administration department fails to discover the medical device registration management systemic and regional risks in the administrative area in time, or fails to eliminate the medical device registration management systemic and regional risks in the administrative area in time, the higher-level drugs The supervisory and administrative department may conduct interviews with the main persons in charge of the lower-level drug supervisory and administrative departments
.
.
Chapter IX Legal Liability
Article 107 Anyone who violates the provisions of Article 79 of these Measures and fails to file the changes as required shall be ordered to make corrections within a time limit; if the correction is not made within the time limit, a fine of 10,000 yuan to 30,000 yuan shall be imposed
.
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Article 108 Those who fail to comply with the clinical trial quality management norms when conducting clinical trials of medical devices shall be punished in accordance with Article 94 of the Regulations on the Supervision and Administration of Medical Devices
.
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Article 109 If a medical device technical review agency fails to perform its duties in accordance with the provisions of these Measures, causing major errors in the review work, the department responsible for drug supervision and administration shall order corrections, notify criticisms, and give warnings; if serious consequences are caused, The legal representative, main responsible person, directly responsible person in charge, and other responsible persons of the illegal unit shall be punished in accordance with the law
.
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Article 110 If the staff of the department responsible for drug supervision and management violates the regulations, abuses their power, neglects their duties, or engages in malpractices for personal gains, they shall be punished in accordance with the law
.
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Chapter 10 Supplementary Provisions
Article 111 In principle, the medical device registration or filing unit shall be based on the technical principle, structural composition, performance index and scope of application of the product
.
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Article 112 The medical device approved for registration refers to the medical device that is consistent with the content of the medical device registration certificate and accessories and is manufactured within the validity period of the medical device registration certificate
.
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Article 113 The combined parts specified in the "Structure and Composition" column of the medical device registration certificate may be sold separately if they are used for the purpose of replacing consumables, after-sales service, and maintenance, etc.
, for the original registered product
.
, for the original registered product
.
Article 114 When applying for medical device product registration, change registration, and clinical trial approval, applicants may be authorized by the owner of the medical device master file to quote the registered medical device master file
.
The work procedures related to the registration of the master file of medical devices shall be stipulated separately
.
.
The work procedures related to the registration of the master file of medical devices shall be stipulated separately
.
Article 115 The format of the medical device registration certificate shall be uniformly formulated by the State Drug Administration
.
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The arrangement method of the registration certificate number is:
×1 Machine Note ×2××××3×4××5××××6
.
in:
.
in:
×1 is the abbreviation of the location of the registration approval department:
Domestic Class III medical devices, imported Class II and Class III medical devices are the word "";
The second category of domestic medical devices is the abbreviation of the province, autonomous region, or municipality where the registration approval department is located;
×2 is the form of registration:
The word "quasi" applies to domestic medical devices;
The word "" applies to imported medical devices;
The word "" is applicable to medical devices in Hong Kong, Macau, and Taiwan;
××××3 is the year of first registration;
×4 is the product management category;
××5 is the product classification code;
××××6 is the serial number of the first registration
.
.
For renewal of registration, the numbers of ××××3 and ××××6 remain unchanged
.
If the product management category is adjusted, it shall be renumbered
.
.
If the product management category is adjusted, it shall be renumbered
.
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Article 22 The drug regulatory authority continues to promote the reform of the review, review and approval system, strengthens regulatory scientific research, establishes an in vitro diagnostic reagent registration management technology system based on technical review and evaluation, and supported by verification, inspection, monitoring and evaluation, and optimizes Review and approve the process, improve the ability of review and approval, and improve the quality and efficiency of review and approval
.
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Article 23 The medical device professional technical institution shall establish a sound communication system, clarify the form and content of communication, and organize communication with applicants according to work needs
.
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Article 24 The medical device professional technical institution shall establish an expert consultation system according to work needs, listen to expert opinions on major issues in the process of review, verification, and inspection, and give full play to the technical support role of experts
.
.
Chapter III Registration of In Vitro Diagnostic Reagents
Section Product Development
Article 25 The development of in-vitro diagnostic reagents shall follow the principles of risk management, consider the current recognized technology level, ensure that all known and foreseeable risks and unanticipated effects of the product are minimized and acceptable, and that the benefits of the product during normal use are greater than Risk
.
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Article 26 Engaging in the research and development of in vitro diagnostic reagent products shall meet the requirements of relevant Chinese laws, regulations and mandatory standards
.
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Article 27 The applicant and the filing party shall compile the product technical requirements for the application for registration or the filing of in-vitro diagnostic reagents
.
.
Product technical requirements mainly include functional, safety indicators and detection methods that can be objectively judged for in vitro diagnostic reagents
.
.
The product technical requirements of the third type of in-vitro diagnostic reagents should specify the main raw materials and production process requirements in the form of an appendix
.
.
In vitro diagnostic reagents should meet the product technical requirements that have been registered or filed
.
.
Article 28 The applicant and the filing party shall prepare the product instructions and labels of the in-vitro diagnostic reagents for registration or filing
.
.
Product instructions and labels shall comply with the requirements of Article 39 and relevant regulations of the Regulations on the Supervision and Administration of Medical Devices
.
.
Article 29 In the development of in vitro diagnostic reagents, non-clinical research on in vitro diagnostic reagents shall be carried out in accordance with the intended use and technical characteristics of the product
.
.
It refers to non-clinical studies or trials for the evaluation of in vitro diagnostic reagents under laboratory conditions, including selection and preparation of major raw materials, production process, analyze the performance of the product, the positive value or the determination reference range study, the product stability and the like
.
.
When applying for registration or filing, non-clinical evidence generated during research and development activities should be submitted
.
.
Article 30 The functional and safety indicators and methods determined in the non-clinical research process of in vitro diagnostic reagents should be compatible with the expected use conditions and purposes of the product, and the research samples should be representative and typical
.
When necessary, methodological verification and statistical analysis shall be carried out
.
.
When necessary, methodological verification and statistical analysis shall be carried out
.
Article 31 When applying for registration or filing, an inspection shall be carried out in accordance with the technical requirements of the product and an inspection report shall be submitted
.
Only those who pass the inspection can start clinical trials or apply for registration and filing
.
.
Only those who pass the inspection can start clinical trials or apply for registration and filing
.
Article 32 When the same registration application includes different packaging specifications, only one type of packaging specification product can be inspected.
The product used for inspection shall be able to represent the safety and effectiveness of the product applied for registration or filing, and its production shall comply with the medical device Relevant requirements of production quality management practices
.
The product used for inspection shall be able to represent the safety and effectiveness of the product applied for registration or filing, and its production shall comply with the medical device Relevant requirements of production quality management practices
.
Article 33 The inspection report submitted for registration or filing may be the self-inspection report of the applicant or the filing person, or the inspection report issued by a qualified medical device inspection agency
.
.
The third type of in-vitro diagnostic reagents shall provide inspection reports of 3 different production batches of products
.
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(2) The applicant has completed the preliminary research of the product and has a basic finalized product, the research process is true and controlled, and the research data is complete and traceable;
(3) The main working principle or mechanism of the product is a domestic initiative, and the performance or safety of the product is fundamentally improved compared with similar products.
It is at the international leading level in technology and has significant clinical application value
.
It is at the international leading level in technology and has significant clinical application value
.
Article 68 To apply for the application of innovative product registration procedures, the applicant shall submit an innovative medical device review application to the State Drug Administration after the product is basically finalized
.
The State Drug Administration organizes experts to review, and those that meet the requirements are included in the innovative product registration procedure
.
.
The State Drug Administration organizes experts to review, and those that meet the requirements are included in the innovative product registration procedure
.
Article 69 For in vitro diagnostic reagent registration applications that apply to the registration procedures of innovative products, the State Drug Administration and the institutions responsible for related technical work shall designate special persons to be responsible for them according to their respective responsibilities, communicate in a timely manner, and provide guidance
.
.
In vitro diagnostic reagents included in the registration procedures of innovative products, the National Bureau’s Device Evaluation Center can discuss major technical issues, major safety issues, clinical trial plans, and phases in product development before the registration application is accepted and during the technical review process.
Communicate on issues such as summary and evaluation of clinical trial results
.
Communicate on issues such as summary and evaluation of clinical trial results
.
Article 70: If the in-vitro diagnostic reagents included in the registration procedure of innovative products, if the applicant voluntarily requests to terminate or the State Drug Administration finds that it no longer meets the requirements of the innovative product registration procedure, the State Drug Administration may terminate the innovative product registration procedure for related products And inform the applicant
.
.
Article 71 For in-vitro diagnostic reagents included in the innovative product registration procedure, if the applicant fails to file an application for registration within the prescribed time limit, the innovative product registration procedure will no longer apply
.
.
Section II Priority Registration Program
Article 72 In vitro diagnostic reagents that meet one of the following conditions may apply for the priority registration procedure:
(1) Diagnose rare diseases and malignant tumors, and have obvious clinical advantages, diagnose peculiar and multiple diseases of the elderly, and there is no effective diagnosis method, dedicated to children and have obvious clinical advantages, or clinically urgently needed and there is no similar species in my country Medical devices whose products have been approved for registration;
(2) Medical devices listed in major national science and technology projects or national key research and development plans;
(3) Other medical devices for which priority registration procedures are applicable as prescribed by the State Drug Administration
.
.
Article 73 Where the priority registration procedure is applied for, the applicant shall submit an application for the priority registration procedure to the State Drug Administration when submitting an application for the registration of in-vitro diagnostic reagents
.
In the case of Paragraph 1 of Article 72, the State Drug Administration shall organize experts to conduct the review, and if it meets the circumstances, it shall be included in the priority registration procedure; in the case of Paragraph 2 of Article 72, it shall be reviewed by the Device Evaluation Center of the State Administration of Upon review, those that are in compliance will be included in the priority registration procedure; in the case of Article 72, Item 3, the State Drug Administration will listen to opinions extensively and organize experts to determine whether to be included in the priority registration procedure
.
.
In the case of Paragraph 1 of Article 72, the State Drug Administration shall organize experts to conduct the review, and if it meets the circumstances, it shall be included in the priority registration procedure; in the case of Paragraph 2 of Article 72, it shall be reviewed by the Device Evaluation Center of the State Administration of Upon review, those that are in compliance will be included in the priority registration procedure; in the case of Article 72, Item 3, the State Drug Administration will listen to opinions extensively and organize experts to determine whether to be included in the priority registration procedure
.
Article 74 For in vitro diagnostic reagent registration applications that are included in the priority registration procedure, the State Drug Administration will give priority to review and approval, and the drug regulatory authorities of provinces, autonomous regions, and municipalities will give priority to the registration quality management system verification
.
.
In the process of technical review of medical device products included in the priority registration procedure, the National Bureau’s Device Evaluation Center shall actively communicate with the applicant in accordance with relevant regulations, and may arrange special exchanges when necessary
.
.
Section III emergency registration procedures
Article 75 The State Drug Administration may respond to public health emergencies in accordance with the law, and there is no similar product on the market in China, or although similar products have been marketed in China, the product supply cannot satisfy the public health emergencies.
Emergency registration of in-vitro diagnostic reagents required for emergency handling of incidents
.
Emergency registration of in-vitro diagnostic reagents required for emergency handling of incidents
.
Article 76 To apply for emergency registration procedures, the applicant shall submit an emergency registration application to the State Drug Administration
.
Those who meet the conditions shall be included in the emergency registration procedure
.
.
Those who meet the conditions shall be included in the emergency registration procedure
.
Article 77 For the registration application of in-vitro diagnostic reagents for emergency registration, the State Drug Administration shall handle the requirements of unified command, early intervention, follow-up review, and scientific approval, and carry out in-vitro diagnostic reagent product inspection, system verification, and Technical review and other work
.
.
Chapter 5 Change of Registration and Renewal of Registration
Section Change registration
Article 78 Registrants shall actively carry out post-market research of in vitro diagnostic reagents, further confirm the safety, effectiveness and quality controllability of in vitro diagnostic reagents, and strengthen the continuous management of marketed in vitro diagnostic reagents
.
.
If the design, raw materials, production process, scope of application, use method, etc.
of the registered in vitro diagnostic reagent products of the second and third categories have undergone substantial changes, which may affect the safety and effectiveness of the in vitro diagnostic reagent, the registrant shall report to the original The registration department applies for change of registration procedures; if other changes occur, it shall be filed with the original registration department within 30 days from the date of the change
.
of the registered in vitro diagnostic reagent products of the second and third categories have undergone substantial changes, which may affect the safety and effectiveness of the in vitro diagnostic reagent, the registrant shall report to the original The registration department applies for change of registration procedures; if other changes occur, it shall be filed with the original registration department within 30 days from the date of the change
.
The product name, packaging specifications, main components, intended use, product technical requirements, product instructions, production address of imported in vitro diagnostic reagents, etc.
stated in the registration certificate are the items that need to be changed registration as specified in the preceding paragraph
.
The name and domicile of the registrant, the name and domicile of the agent, etc.
, are matters that need to be filed as prescribed in the preceding paragraph
.
If the domestic in-vitro diagnostic reagent production address is changed, the registrant shall go through the filing procedures after handling the corresponding production license change
.
stated in the registration certificate are the items that need to be changed registration as specified in the preceding paragraph
.
The name and domicile of the registrant, the name and domicile of the agent, etc.
, are matters that need to be filed as prescribed in the preceding paragraph
.
If the domestic in-vitro diagnostic reagent production address is changed, the registrant shall go through the filing procedures after handling the corresponding production license change
.
In the event of other changes, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug regulatory authority in accordance with regulations
.
.
Article 79 For the registered type II and type III in-vitro diagnostic reagents, the core technical principles of the products have undergone substantial changes, or other major changes, which have a significant impact on the safety and effectiveness of the products, constitute new products in essence.
Products that do not belong to the items of the change application specified in this chapter shall be handled in accordance with the provisions of the registration application
.
Products that do not belong to the items of the change application specified in this chapter shall be handled in accordance with the provisions of the registration application
.
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Article 112 The registration or filing unit of in-vitro diagnostic reagents shall be a single reagent or a single kit, and a registration or filing unit may include different packaging specifications
.
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Calibrators and quality control products can be combined with in vitro diagnostic reagents to apply for registration, or they can be applied for registration separately
.
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Article 113 The in-vitro diagnostic reagents that have been approved for registration refer to the in-vitro diagnostic reagents that are consistent with the contents of the medical device registration certificate and accessories and are produced within the validity period of the medical device registration certificate
.
.
Article 114 The independent reagent components listed in the "Main Components" column of the medical device registration certificate may be sold separately if they are used in the original registered product
.
.
Article 115 When applying for in-vitro diagnostic reagent product registration or change registration, the applicant may be authorized by the owner of the medical device master file to cite the registered medical device master file
.
The main file of the medical device shall be registered by its owner or agency, and the relevant working procedures shall be stipulated separately
.
.
The main file of the medical device shall be registered by its owner or agency, and the relevant working procedures shall be stipulated separately
.
Article 116 The format of the medical device registration certificate shall be uniformly formulated by the State Drug Administration
.
.
The arrangement method of the registration certificate number is:
×1 Machine Note ×2××××3×4××5××××6
.
in:
.
in:
×1 is the abbreviation of the location of the registration approval department:
Domestic Class III in-vitro diagnostic reagents, imported Class II and Class III in-vitro diagnostic reagents are the word "";
The second category of in-vitro diagnostic reagents in China is the abbreviation of the province, autonomous region, or municipality where the registration approval department is located;
×2 is the form of registration:
The word "quasi" is applicable to domestic in vitro diagnostic reagents;
The word "" is applicable to imported in vitro diagnostic reagents;
The word "" is applicable to in vitro diagnostic reagents in Hong Kong, Macau and Taiwan;
××××3 is the year of first registration;
×4 is the product management category;
××5 is the product classification code;
××××6 is the serial number of the first registration
.
.
For renewal of registration, the numbers of ××××3 and ××××6 remain unchanged
.
If the product management category is adjusted, it shall be renumbered
.
.
If the product management category is adjusted, it shall be renumbered
.
Article 117 presentation of the first class of medical devices record number is:
×1 Equipment ××××2××××3
.
.
in:
×1 is the abbreviation of the location of the filing department:
Imported first-class in vitro diagnostic reagents are the word "";
The first category of in-vitro diagnostic reagents in China is the abbreviation of the province, autonomous region, or municipality where the filing department is located, plus the abbreviation of the city-level administrative region where it is located (when there is no corresponding city-level administrative region that is divided into districts, only the abbreviation of the province, autonomous region, or municipality) ；
××××2 is the filing year;
××××3 is the serial number of the record
.
.
Article 118 Drug regulatory department made Medical Device Registration Certificate, change registration documents electronic documents and paper files have the same legal effect
.
.
Article 119 According to the needs of the work, the State Drug Administration may entrust the drug regulatory department or technical institution or social organization of a province, autonomous region, or municipality directly under the Central Government to undertake relevant specific tasks in accordance with the law
.
.
Article 120 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government may refer to the provisions of Chapter 4 of these Measures to formulate special registration procedures for the second type of in vitro diagnostic reagents within their administrative regions, and report to the State Drug Administration for the record
.
.
Article 121 The charging items and charging standards for the registration of in-vitro diagnostic reagent products shall be implemented in accordance with the relevant regulations of the finance and price authorities of the State Council
.
.
Article 122 The relevant regulations on the emergency use of in-vitro diagnostic reagents shall be separately formulated by the State Drug Administration in conjunction with relevant departments
.
.
Article 123 There is no product of the same product on the market in China.
Medical institutions develop in-vitro diagnostic reagents based on their own clinical needs and use them under the guidance of medical practitioners.
The relevant management regulations are governed by the State Drug Administration.
It will be formulated separately in conjunction with relevant departments
.
Medical institutions develop in-vitro diagnostic reagents based on their own clinical needs and use them under the guidance of medical practitioners.
The relevant management regulations are governed by the State Drug Administration.
It will be formulated separately in conjunction with relevant departments
.
Article 124 The registration and filing of in-vitro diagnostic reagents in Hong Kong, Macau, and Taiwan shall refer to imported in-vitro diagnostic reagents
.
.
Article 125 These Measures shall come into force on October 1, 2021
.
The "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" promulgated by Order No.
5 of the former State Food and Drug Administration on July 30, 2014 shall be repealed at the same time
.
.
The "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" promulgated by Order No.
5 of the former State Food and Drug Administration on July 30, 2014 shall be repealed at the same time
.
Medical News, September 2
Order of the State Administration for Market Regulation
Order of the State Administration for Market Regulation 47 No.
47 No. The "Administrative Measures for the Registration and Filing of Medical Devices" have been adopted at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021, and are hereby promulgated and shall come into force on October 1, 2021
.
.
Director Zhang Gong
August 26, 2021
Medical Device Registration and Filing Management Measures
Medical Device Registration and Filing Management Measures Chapter One General Provisions
Chapter One General Provisions Article 1 In order to regulate the registration and filing of medical devices and ensure the safety, effectiveness and quality control of medical devices, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices
.
.
Article 2 These Measures shall apply to medical device registration, filing and supervision and management activities within the territory of the People's Republic of China
.
.
Article 3 Medical device registration means that the applicant for medical device registration (hereinafter referred to as the applicant) submits an application for medical device registration in accordance with statutory procedures and requirements.
The quality controllability and other reviews are used to determine whether to approve the activities they have applied for
.
The quality controllability and other reviews are used to determine whether to approve the activities they have applied for
.
Medical device filing refers to the activity of the medical device filing person (hereinafter referred to as the filing person) submitting filing materials to the drug regulatory authority in accordance with legal procedures and requirements, and the drug regulatory authority filing the submitted filing materials for review
.
.
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Article 29 The functional and safety indicators and methods determined in the process of medical device non-clinical research should be compatible with the expected use conditions and purpose of the product, and the research samples should be representative and typical
.
When necessary, methodological verification and statistical analysis shall be carried out
.
.
When necessary, methodological verification and statistical analysis shall be carried out
.
Article 30 When applying for registration or filing, an inspection shall be carried out in accordance with the technical requirements of the product and an inspection report shall be submitted
.
Only those who pass the inspection can start clinical trials or apply for registration and filing
.
.
Only those who pass the inspection can start clinical trials or apply for registration and filing
.
Article 31 The product for inspection shall be able to represent the safety and effectiveness of the product applied for registration or filing, and its production shall comply with the relevant requirements of the medical device production quality management standard
.
.
Article 32 The medical device product inspection report submitted for registration or filing may be a self-inspection report of the applicant or filing person, or an inspection report issued by a qualified medical device inspection agency
.
.
II clinical evaluation
II clinical evaluation Article 33 In addition to the circumstances specified in Article 34 of these Measures, the registration and filing of medical device products shall be subject to clinical evaluation
.
.
Clinical evaluation of medical devices refers to the use of scientific and reasonable methods to analyze and evaluate clinical data to confirm the safety and effectiveness of medical devices within their scope of application
.
.
To apply for medical device registration, clinical evaluation materials shall be submitted
.
.
Article 34 Those in any of the following circumstances may be exempt from clinical evaluation:
(1) The working mechanism is clear, the design is finalized, the production process is mature, the medical devices of the same variety that have been marketed have been used in clinical applications for many years, there is no record of serious adverse events, and the conventional use is not changed;
(2) Other non-clinical evaluations can prove that the medical device is safe and effective
.
.
Those who are exempt from clinical evaluation may be exempt from submitting clinical evaluation data
.
.
The list of medical devices exempt from clinical evaluation shall be formulated, adjusted and published by the State Drug Administration
.
.
Article 35 The clinical evaluation of medical devices can be carried out according to the product characteristics, clinical risks, existing clinical data, etc.
, through clinical trials, or through analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices to prove the medical treatment.
The safety and effectiveness of the device
.
, through clinical trials, or through analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices to prove the medical treatment.
The safety and effectiveness of the device
.
According to the provisions of the State Drug Administration, when conducting clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the product safety and effectiveness of medical devices, clinical trials should be carried out
.
.
State Drug Administration to develop guidelines for clinical evaluation of medical devices, specifically by requiring the clinical evaluation of clinical documentation, clinical data with the variety of medical devices, the need for the case of clinical trials, write requirements of clinical evaluation reports and other
.
.
Article 36 For clinical evaluations based on the clinical documentation and clinical data of the same variety of medical devices, the clinical evaluation data includes the comparison between the product applied for registration and the same variety of medical devices, the analysis and evaluation of the clinical data of the same variety of medical devices, and the comparison between the product applied for registration and the Scientific evidence and evaluation conclusions when there are differences between products of the same variety
.
.
To carry out clinical evaluation of clinical trials, clinical evaluation information, including clinical trial program, the ethics committee opinion, informed consent, clinical trial reports
.
.
Article 37 The clinical trials of medical devices shall be carried out in medical device clinical trial institutions that have the corresponding conditions and are filed in accordance with the regulations in accordance with the requirements of the quality management standards for medical device clinical trials
.
Before the start of a clinical trial, the clinical trial sponsor shall file a clinical trial record with the local drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government
.
The production of clinical trial medical devices shall meet the relevant requirements of the medical device production quality management norms
.
.
Before the start of a clinical trial, the clinical trial sponsor shall file a clinical trial record with the local drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government
.
The production of clinical trial medical devices shall meet the relevant requirements of the medical device production quality management norms
.
Article 38 The clinical trials of Class III medical devices that pose a high risk to humans shall be approved by the State Drug Administration
.
.
Clinical trial approval refers to the comprehensive analysis of the medical device's risk level, clinical trial plan, clinical benefit and risk comparative analysis report, etc.
, according to the applicant’s application by the National Medical Products Administration, in order to decide whether to approve the clinical trial.
The process of testing
.
, according to the applicant’s application by the National Medical Products Administration, in order to decide whether to approve the clinical trial.
The process of testing
.
The list of the third category of medical devices subject to clinical trial approval shall be formulated, adjusted and published by the State Drug Administration
.
The third-class medical device clinical trials that require clinical trial approval should be carried out in third-class medical institutions that meet the requirements
.
.
The third-class medical device clinical trials that require clinical trial approval should be carried out in third-class medical institutions that meet the requirements
.
Article 39 Where medical device clinical trial approval is required, the applicant shall submit application materials such as summary materials, research materials, clinical materials, product instructions, and label samples in accordance with relevant requirements
.
.
Article 40 The Device Evaluation Center of the State Administration of China shall review the accepted clinical trial applications
.
For clinical trial applications, a decision on whether to approve or not shall be made within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the National Bureau of Device Evaluation Center
.
Failure to notify within the time limit shall be deemed as consent
.
.
For clinical trial applications, a decision on whether to approve or not shall be made within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the National Bureau of Device Evaluation Center
.
Failure to notify within the time limit shall be deemed as consent
.
Article 41 If the applicant needs to supplement and correct the materials during the review process, the National Bureau of Equipment Review Center shall notify all the contents that need to be supplemented and corrected at one time
.
The applicant shall provide supplementary materials once in accordance with the requirements of the supplementary notice within one year after receiving the notice of supplementary correction
.
After receiving the supplementary materials, the Device Evaluation Center of the National Bureau will complete the technical evaluation within the prescribed time limit
.
.
The applicant shall provide supplementary materials once in accordance with the requirements of the supplementary notice within one year after receiving the notice of supplementary correction
.
After receiving the supplementary materials, the Device Evaluation Center of the National Bureau will complete the technical evaluation within the prescribed time limit
.
If the applicant disagrees with the content of the notice of supplementation and correction, he may submit a written opinion to the National Bureau of Device Evaluation Center, explain the reason and provide corresponding technical support materials
.
.
If the applicant fails to submit supplementary materials within the time limit, the technical review shall be terminated and a decision shall be made not to approve
.
.
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Article 71.
For medical devices that are included in the innovative product registration procedure, if the applicant voluntarily requests termination or the State Drug Administration finds that it no longer meets the requirements of the innovative product registration procedure, the State Drug Administration shall terminate the relevant product’s innovative product registration procedure and Inform the applicant
.
For medical devices that are included in the innovative product registration procedure, if the applicant voluntarily requests termination or the State Drug Administration finds that it no longer meets the requirements of the innovative product registration procedure, the State Drug Administration shall terminate the relevant product’s innovative product registration procedure and Inform the applicant
.
Article 72 For medical devices that are included in the innovative product registration procedure, if the applicant fails to file an application for registration within the prescribed time limit, the innovative product registration procedure will no longer apply
.
.
Section II Priority Registration Program
Section II Priority Registration Program Article 73 Medical devices that meet one of the following conditions may apply for the priority registration procedure:
(1) Diagnosis or treatment of rare diseases and malignant tumors with obvious clinical advantages, diagnosis or treatment of peculiar and multiple diseases of the elderly and there is currently no effective diagnosis or treatment method, dedicated to children with obvious clinical advantages, or clinically urgently needed and in There is no medical device with the same product type approved for registration in my country;
(2) Medical devices listed in major national science and technology projects or national key research and development plans;
(3) Other medical devices for which priority registration procedures are applicable as prescribed by the State Drug Administration
.
.
Article 74 Where the priority registration procedure is applied for, the applicant shall submit an application for the priority registration procedure to the State Drug Administration when submitting an application for medical device registration
.
In the case of the first item of Article 73, the State Drug Administration shall organize experts to conduct the review, and those that are in line will be included in the priority registration procedure; in the case of the second item of Article 73, the National Bureau of Device Evaluation Center Upon review, those that are in compliance will be included in the priority registration procedure; in the case of the third item of Article 73, the State Drug Administration will listen to opinions extensively and organize experts to determine whether to be included in the priority registration procedure
.
.
In the case of the first item of Article 73, the State Drug Administration shall organize experts to conduct the review, and those that are in line will be included in the priority registration procedure; in the case of the second item of Article 73, the National Bureau of Device Evaluation Center Upon review, those that are in compliance will be included in the priority registration procedure; in the case of the third item of Article 73, the State Drug Administration will listen to opinions extensively and organize experts to determine whether to be included in the priority registration procedure
.
Article 75 For medical device registration applications that are included in the priority registration procedure, the State Drug Administration will give priority to review and approval, and the drug regulatory authorities of provinces, autonomous regions, and municipalities will give priority to medical device registration quality management system verification
.
.
In the process of technical review of medical device products included in the priority registration procedure, the National Bureau’s Device Evaluation Center shall actively communicate with the applicant in accordance with relevant regulations, and may arrange special exchanges when necessary
.
.
Section III emergency registration procedures
Section III emergency registration procedures Article 76 The State Drug Administration may respond to public health emergencies in accordance with the law, and there is no similar product on the market in China, or although similar products have been listed in China, the product supply cannot meet the needs of public health emergencies.
Emergency registration of medical devices required for emergency handling of incidents
.
Emergency registration of medical devices required for emergency handling of incidents
.
Article 77 To apply for emergency registration procedures, the applicant shall submit an emergency registration application to the State Drug Administration
.
Those who meet the conditions shall be included in the emergency registration procedure
.
.
Those who meet the conditions shall be included in the emergency registration procedure
.
Article 78 For medical device registration applications for emergency registration, the National Medical Products Administration shall handle the requirements of unified command, early intervention, follow-up review, and scientific approval, and conduct medical device product inspection, system verification, and technical review in parallel.
Rating work
.
Rating work
.
Chapter 5 Change of Registration and Renewal of Registration
Chapter 5 Change of Registration and Renewal of Registration Section Change registration
Section Change registration Article 79 Registrants shall actively carry out post-marketing research on medical devices, further confirm the safety, effectiveness and quality controllability of medical devices, and strengthen the continuous management of medical devices already on the market
.
.
If the design, raw materials, production process, scope of application, method of use, etc.
of registered medical device products of Class II and Class III undergo substantial changes, which may affect the safety and effectiveness of the medical device, the registrant shall report to the original registration department.
Apply to go through the formalities of changing the registration; if there are other changes, it shall be filed with the original registration department within 30 days from the date of the change
.
of registered medical device products of Class II and Class III undergo substantial changes, which may affect the safety and effectiveness of the medical device, the registrant shall report to the original registration department.
Apply to go through the formalities of changing the registration; if there are other changes, it shall be filed with the original registration department within 30 days from the date of the change
.
The product name, model, specification, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc.
stated in the registration certificate are the items that need to be registered for change as specified in the preceding paragraph
.
The name and domicile of the registrant, the name and domicile of the agent, etc.
, are matters that need to be filed as prescribed in the preceding paragraph
.
If the domestic medical device production address is changed, the registrant shall file for the record after handling the corresponding production license change
.
stated in the registration certificate are the items that need to be registered for change as specified in the preceding paragraph
.
The name and domicile of the registrant, the name and domicile of the agent, etc.
, are matters that need to be filed as prescribed in the preceding paragraph
.
If the domestic medical device production address is changed, the registrant shall file for the record after handling the corresponding production license change
.
In the event of other changes, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug regulatory authority in accordance with regulations
.
.
Article 80 With regard to the application for change registration, the technical review agency shall focus on the review of the changed part, and form an review opinion on whether the product after the change is safe, effective, and controllable in quality
.
.
In the technical review of the application for change registration, if it is deemed necessary to verify the quality management system, the drug regulatory authority shall organize the quality management system verification
.
.
Article 81 The medical device modification registration document is used in combination with the original medical device registration certificate, and the expiration date of the validity period is the same as that of the original medical device registration certificate
.
.
Section II continued registration
Section II continued registration Article 82 If the medical device registration certificate expires and needs to be renewed, the registrant shall apply to the original registration department for registration renewal 6 months before the expiration of the medical device registration certificate, and submit the application materials in accordance with relevant requirements
.
.
Except for the circumstances stipulated in Article 83 of these Measures, the drug regulatory authority that receives an application for renewal shall make a decision to approve the renewal before the expiration of the medical device registration certificate
.
If no decision is made within the time limit, it shall be deemed that the renewal is approved
.
.
If no decision is made within the time limit, it shall be deemed that the renewal is approved
.
Article 83 In any of the following circumstances, registration shall not be renewed:
(1) Failure to file an application for renewal of registration within the prescribed time limit;
(2) The new mandatory standards for medical devices are issued and implemented, and the medical devices applying for renewal of registration cannot meet the new requirements;
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Article 116 presentation of the first class of medical devices record number is:
Article 116 presentation of the first class of medical devices record number is: ×1 Equipment ××××2××××3
.
in:
.
in:
×1 is the abbreviation of the location of the filing department:
×1 is the abbreviation of the location of the filing department: Imported first-class medical devices are the word "";
The first category of medical devices in the country is the abbreviation of the province, autonomous region, or municipality directly under the Central Government where the filing department is located, plus the abbreviation of the city-level administrative region where it is located (when there is no corresponding municipal-level administrative region divided into districts, it is only the abbreviation of the province, autonomous region, or municipality directly under the Central Government);
××××2 is the filing year;
××××3 is the serial number of the record
.
.
Article 117 The electronic documents and paper documents of the medical device registration certificate and modification registration documents produced by the drug regulatory authority shall have the same legal effect
.
.
Article 118 According to the needs of the work, the State Drug Administration may entrust the drug regulatory department or technical institution or social organization of a province, autonomous region, or municipality directly under the Central Government to undertake specific tasks
.
.
Article 119 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government may refer to Chapter 4 of these Measures to formulate special registration procedures for Class II medical devices in their administrative regions, and report to the State Drug Administration for the record
.
.
Article 120 The charging items and charging standards for medical device product registration shall be implemented in accordance with the relevant regulations of the State Council’s finance and price authorities
.
.
Article 121 In accordance with the registration and filing of in vitro diagnostic reagents under the management of medical devices, the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" apply
.
.
Article 122 The relevant regulations for the supervision and management of customized medical devices shall be separately formulated by the State Drug Administration
.
.
The relevant regulations on the registration and administration of drug-device combination products shall be separately formulated by the State Drug Administration
.
.
The relevant regulations on the emergency use of medical devices shall be separately formulated by the State Drug Administration in conjunction with relevant departments
.
.
Article 123 The registration and filing of medical devices in Hong Kong, Macau, and Taiwan shall refer to imported medical devices
.
.
Article 124 These Measures shall come into force on October 1, 2021
.
The "Measures for the Administration of Medical Device Registration" promulgated by Order No.
4 of the former State Food and Drug Administration on July 30, 2014 shall be repealed at the same time
.
.
The "Measures for the Administration of Medical Device Registration" promulgated by Order No.
4 of the former State Food and Drug Administration on July 30, 2014 shall be repealed at the same time
.
Order of the State Administration for Market Regulation
Order of the State Administration for Market Regulation 48 No.
48 No. The "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" was adopted at the 11th executive meeting of the State Administration of Market Supervision on July 22, 2021.
It is hereby promulgated and shall come into force on October 1, 2021
.
It is hereby promulgated and shall come into force on October 1, 2021
.
Secretary Zhang Gong
Secretary Zhang GongAugust 26 , 2021
August 26 , 2021 Management Measures for the Registration and Filing of In Vitro Diagnostic Reagents
Management Measures for the Registration and Filing of In Vitro Diagnostic Reagents Chapter One General Provisions
Chapter One General Provisions Article 1 In order to regulate the registration and filing of in-vitro diagnostic reagents and ensure the safety, effectiveness and quality control of in-vitro diagnostic reagents, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices
.
.
Article 2 These Measures apply to the registration, filing and supervision and management of in-vitro diagnostic reagents within the territory of the People's Republic of China
.
.
Article 3 The in-vitro diagnostic reagents mentioned in these Measures refer to the in-vitro diagnostic reagents managed by medical devices, including those used in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation.
The tested reagents, kits, calibrators, quality control products and other products can be used alone or in combination with instruments, appliances, equipment or systems
.
The tested reagents, kits, calibrators, quality control products and other products can be used alone or in combination with instruments, appliances, equipment or systems
.
The in vitro diagnostic reagents used for blood source screening and the in vitro diagnostic reagents labeled with radionuclides in accordance with the management of drugs do not fall within the scope of the regulations
.
.
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。：
。：
×1：
×1： 、、“”；
、、；
×2：
×2： “”；
“”；
“”、、；
××××3；
×4；
××5；
××××6
。
。
For renewal of registration, the numbers of ××××3 and ××××6 remain unchanged
.
If the product management category is adjusted, it shall be renumbered
.
.
If the product management category is adjusted, it shall be renumbered
.
Article 117 presentation of the first class of medical devices record number is:
Article 117 presentation of the first class of medical devices record number is: ×1 Equipment ××××2××××3
.
.
in:
in: ×1 is the abbreviation of the location of the filing department:
×1 is the abbreviation of the location of the filing department: Imported first-class in vitro diagnostic reagents are the word "";
The first category of in-vitro diagnostic reagents in China is the abbreviation of the province, autonomous region, or municipality where the filing department is located, plus the abbreviation of the city-level administrative region where it is located (when there is no corresponding city-level administrative region that is divided into districts, only the abbreviation of the province, autonomous region, or municipality) ；
××××2 is the filing year;
××××3 is the serial number of the record
.
.
Article 118 Drug regulatory department made Medical Device Registration Certificate, change registration documents electronic documents and paper files have the same legal effect
.
Medicine, medicine, medicine.
Article 119 According to the needs of the work, the State Drug Administration may entrust the drug regulatory department or technical institution or social organization of a province, autonomous region, or municipality directly under the Central Government to undertake relevant specific tasks in accordance with the law
.
.
Article 120 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government may refer to the provisions of Chapter 4 of these Measures to formulate special registration procedures for the second type of in vitro diagnostic reagents within their administrative regions, and report to the State Drug Administration for the record
.
.
Article 121 The charging items and charging standards for the registration of in-vitro diagnostic reagent products shall be implemented in accordance with the relevant regulations of the finance and price authorities of the State Council
.
.
Article 122 The relevant regulations on the emergency use of in-vitro diagnostic reagents shall be separately formulated by the State Drug Administration in conjunction with relevant departments
.
.
Article 123 There is no product of the same product on the market in China.
Medical institutions develop in-vitro diagnostic reagents based on their own clinical needs and use them under the guidance of medical practitioners.
The relevant management regulations are governed by the State Drug Administration.
It will be formulated separately in conjunction with relevant departments
.
Medical institutions develop in-vitro diagnostic reagents based on their own clinical needs and use them under the guidance of medical practitioners.
The relevant management regulations are governed by the State Drug Administration.
It will be formulated separately in conjunction with relevant departments
.
Article 124 The registration and filing of in-vitro diagnostic reagents in Hong Kong, Macau, and Taiwan shall refer to imported in-vitro diagnostic reagents
.
.
Article 125 These Measures shall come into force on October 1, 2021
.
The "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" promulgated by Order No.
5 of the former State Food and Drug Administration on July 30, 2014 shall be repealed at the same time
.
.
The "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" promulgated by Order No.
5 of the former State Food and Drug Administration on July 30, 2014 shall be repealed at the same time
.
