The introduction of new regulations on medical device production and operation strengthens the supervision and management of medical device registrants

Recently, the State Administration for Market Regulation issued the revised "Measures for the Supervision and Administration of Medical Device Production" and "Measures for the Supervision and Administration of Medical Device Operation", which will come into force on May 1, 2022
.
The "Measures" mentioned that the strictest regulatory requirements should be implemented
.
Strengthen the supervision and management of medical device registrants, clarify the responsibilities of both the registrant and the entrusted manufacturer, incorporate the relevant requirements of entrusted production management into the quality management system, and further improve the inspection responsibilities, inspection methods, results disposal, and investigations of medical device production.
Forensics and other regulatory requirements
.
Improve the management requirements for sales, transportation, storage and other aspects of the business process, refine the relevant provisions on the traceability management of purchase inspection, sales records, etc.
, and strengthen the registrant and filer's responsibility for the quality and safety of medical devices that they have registered and filed
.
Annex: Chapter 1 General Provisions Article 1 In order to strengthen the supervision and management of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices
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Article 2 Those engaged in the production of medical devices and their supervision and administration within the territory of the People's Republic of China shall abide by these Measures
.
Article 3 To engage in medical device production activities, it shall abide by laws, regulations, rules, mandatory standards and medical device production quality management practices, and ensure that the information in the whole process of medical device production is true, accurate, complete and traceable
.
Medical device registrants and filers are responsible for the safety and effectiveness of listed medical devices
.
Article 4 According to the degree of risk of medical devices, the production of medical devices is subject to classified management
.
To engage in the production activities of Class II and Class III medical devices, it shall be approved by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located, and obtain a medical device production license according to law; The municipal department in charge of drug supervision and administration shall handle the filing of medical device production
.
Article 5 The State Drug Administration shall be responsible for the supervision and administration of the production of medical devices throughout the country
.
The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of the production of Class II and Class III medical devices in their respective administrative regions, and are responsible for the supervision and administration of the production of Class I medical devices in their respective administrative regions in accordance with their duties in accordance with the law, and strengthen the supervision and administration of Class I medical devices in their respective administrative regions.
Guidance for the supervision and management of medical device production
.
The departments responsible for drug supervision and administration at the city level with districts shall supervise and manage the production activities of Class I medical devices in their respective administrative regions in accordance with the law
.
Article 6 The medical device review, inspection, inspection, monitoring and evaluation and other professional technical institutions established or designated by the drug regulatory department according to the law shall undertake relevant technical work according to the division of responsibilities, and provide technical support for the supervision and management of medical device production
.
The Food and Drug Review and Inspection Center of the State Drug Administration organizes the formulation of medical device inspection system specifications and technical documents, undertakes major cause-based inspections and overseas inspections, etc.
, and guides and evaluates the quality management systems of medical device inspection institutions in provinces, autonomous regions, and municipalities directly under the Central Government.

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Article 7 The State Drug Administration shall strengthen the information construction of medical device production supervision and management, and improve the level of online government services
.
The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the information construction and management of medical device production supervision and management in their respective administrative regions, and coordinate and promote the sharing of medical device production supervision and management information in accordance with the requirements of the State Drug Administration
.
Article 8 The drug regulatory department shall disclose information such as medical device production license, filing, supervision and inspection, and administrative punishment in a timely manner in accordance with the law, so as to facilitate public inquiries and accept social supervision.

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Chapter II Production Licensing and Filing Management Article 9 To engage in medical device production activities, the following conditions shall be met: (1) There are production sites, environmental conditions, production equipment and professional technicians that are compatible with the medical devices to be produced; (2) (3) Having a management system to ensure the quality of medical devices; (4) Having after-sales service capabilities that are suitable for the medical devices produced; (5) ) meet the requirements of product development and production process documents
.
Article 10 Those engaged in the production of Class II and Class III medical devices in China shall apply to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government for a production license, and submit the following materials: (1) The medical device registration certificate produced; A photocopy of the product technical requirements; (2) A photocopy of the identity certificate of the legal representative (person in charge of the enterprise); (3) A photocopy of the identity, educational background and professional title of the person in charge of production, quality and technology; (4) Production management, quality List of educational qualifications and professional titles of employees in the inspection positions; (5) Copies of relevant documents of the production site, and if there are special production environment requirements, copies of relevant documents of facilities and environment should also be submitted; (6) Catalogue of main production equipment and inspection equipment; (7) Catalogue of quality manuals and program documents; (8) Flow chart of production process; (9) Relevant materials proving the ability of after-sales service; (10) Authorization documents of the person in charge
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Applicants should ensure that the submitted materials are legal, true, accurate, complete and traceable
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Relevant materials can be checked online without the need for applicants to provide
.
Article 11 After receiving the application, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall deal with it according to the following circumstances: (1) The application matters are within the scope of the authority of the administrative organ, and if the application materials are complete and conform to the statutory form, the application shall 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 statutory form, the applicant shall be notified on the spot or within 5 working days of the need for corrections.
If the application is not notified within the time limit, it will be accepted from the date of receipt of the application materials; (4) If the application matters do not fall within the scope of the administrative organ’s powers according to law, it shall immediately make a decision not to accept the application, and inform the applicant to report to the Application to the relevant administrative agency
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Where the drug regulatory department of a province, autonomous region or municipality directly under the Central Government accepts or rejects an application for a medical device production license, it shall issue a notification of acceptance or rejection affixed with the special seal of the administrative organ and dated
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Article 12 For matters that are required to be heard for the implementation of administrative licensing as stipulated by laws, regulations and rules, or other major administrative licensing matters involving public interests that the drug regulatory department deems to require a hearing, the drug regulatory department shall announce to the public and hold a hearing
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Where an application for a medical device production license directly involves a significant interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties that they have the right to request a hearing before making an administrative licensing decision
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Article 13 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall review the application materials and conduct inspections in accordance with the requirements of the Good Manufacturing Practice for Medical Devices formulated by the State Drug Administration, and 20 working days from the date of accepting the application decision within
.
On-site inspections can be combined with product registration system inspections to avoid repeated inspections
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If rectification is required, the rectification time is not included in the review time limit
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If the prescribed conditions are met, a written decision to grant the license shall be made in accordance with the law, and a "Medical Device Production License" shall be issued within 10 working days; The applicant has the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law
.
Article 14 The medical device production license is divided into the original and the duplicate, and the validity period is 5 years
.
The original and duplicates shall indicate the license number, enterprise name, unified social credit code, legal representative (person in charge of the enterprise), residence, production address, production scope, issuing department, issuing date and validity period
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The duplicate records the changes in the items stated in the original license and the major transformation of the workshop or production line
.
Items such as enterprise name, unified social credit code, legal representative (person in charge of the enterprise), and domicile shall be consistent with the relevant content stated in the business license
.
The medical device production license shall be uniformly formatted by the State Drug Administration and printed by the drug administration departments of provinces, autonomous regions and municipalities directly under the Central Government
.
The electronic certificate of medical device production license has the same legal effect as the paper certificate
.
Article 15 If the production address is changed or the production scope is increased, the original license-issuing department shall apply to the original license-issuing department for the modification of the medical device production license, and submit the relevant materials related to the content of the change as stipulated in Article 10 of these Measures.
The original license-issuing department shall comply with Article 10 of these Measures.
Article 13 shall be reviewed and on-site inspection shall be carried out
.
If the workshop or production line is modified, resulting in changes in production conditions, which may affect the safety and effectiveness of medical devices, it shall be reported to the original licensing department
.
In the event of a change in licensing matters, the relevant licensing change procedures shall be handled in accordance with the regulations
.
Article 16 If the name of the enterprise, legal representative (person in charge of the enterprise), domicile is changed, or the production address is changed in words, and the production scope is reduced after verification, it shall apply to the original certificate issuing department for the change of registration items within 30 working days after the change.
and submit relevant materials
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The original license-issuing department shall complete the change of registration items within 5 working days
.
Article 17 If the validity period of the medical device production license is renewed, the renewal application shall be submitted within 90 working days to 30 working days before the validity period expires
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If the renewal application is not submitted within the time limit, the renewal application will not be accepted
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The original license-issuing department shall review the enterprise's compliance with medical device management laws and regulations, medical device production quality management standards, and the operation of the enterprise's quality management system, conduct on-site inspections if necessary, and decide whether to approve the renewal before the expiration of the medical device production license.
decision
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After review, if the prescribed conditions are met, the renewal will be granted, and the number of the renewed medical device production license will remain unchanged
.
Those who do not meet the prescribed conditions shall be ordered to make corrections within a time limit; if they still fail to meet the prescribed conditions after rectification, they shall not be renewed, and the reasons shall be explained in writing
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If the approval time for the renewal of the license is within the validity period of the original license, the start date of the renewal shall be the day following the expiry date of the original license; if the approval time is not within the validity period of the original license, the start date of the renewal shall be the date on which the renewal of the license is approved
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Article 18 If a medical device manufacturing enterprise establishes a production site across provinces, autonomous regions or municipalities directly under the Central Government, it shall apply to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the new production site is located for a medical device production license
.
Article 19 If a medical device production license is lost, an application shall be submitted to the original license-issuing department for reissuance
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The original license-issuing department shall reissue the medical device production license in a timely manner, and the number and validity period of the reissued medical device production license shall be consistent with the original license
.
Article 20 If the original or duplicate of the medical device production license is changed, the license-issuing department shall re-issue the original and duplicate of the changed medical device production license, and take back the original and duplicate of the original license; if only the duplicate is changed, the license-issuing department shall Re-issue the changed copy of the medical device production license, and take back the original copy of the license
.
The changed medical device production license number and validity period remain unchanged
.
Article 21 In any of the following circumstances, the original license-issuing department shall cancel the medical device production license according to law and make an announcement: (1) Those who apply for cancellation on their own initiative; (2) Those who have not extended the validity period; The subject qualification is terminated in accordance with the law; (4) The medical device production license is revoked or revoked in accordance with the law; (5) Other circumstances under which the administrative license should be cancelled according to laws and regulations
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Article 22 Those engaged in the production of Class I medical devices shall file with the department in charge of drug supervision and administration at the city divided into districts where they are located.
After submitting the relevant materials stipulated in Article 10 of these Measures, the production filing shall be completed and the filing shall be obtained.
number
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If the medical device recorder produces the first-class medical device by itself, it can also go through the production record when handling the product record
.
The drug regulatory department shall, within 3 months from the date of production filing, conduct an on-site inspection of the submitted materials and the implementation of the medical device production quality management standard
.
Those that do not meet the requirements of the medical device production quality management standard shall be dealt with in accordance with the law and shall be ordered to make corrections within a time limit; if the safety and effectiveness of the products cannot be guaranteed, the filing shall be cancelled and an announcement shall be made to the public
.
Article 23 If there is any change in the content of the production record of Class I medical devices, the materials related to the change as specified in Article 10 of these Measures shall be submitted to the original recordation department within 10 working days.
On-site verification shall be carried out in accordance with the provisions of Article 22 of the Measures
.
Article 24 No unit or individual may forge, alter, trade, lease or lend medical device production licenses
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Chapter III Production Quality Management Article 25 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall, in accordance with the requirements of the medical device production quality management standards, establish and improve a quality management system suitable for the medical devices produced and maintain its effectiveness It operates, and organizes production in strict accordance with the registered or filed product technical requirements to ensure that the ex-factory medical devices meet the mandatory standards and the registered or filed product technical requirements
.
Article 26 The legal representatives and principals of medical device registrants and filing persons are fully responsible for the quality and safety of the medical devices they produce
.
Article 27 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall be equipped with management representatives
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The management representative is appointed by the legal representative or the main person in charge to perform the responsibilities of establishing, implementing and maintaining the effective operation of the quality management system
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Article 28 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall carry out training on medical device laws, regulations, rules, standards and quality management, establish training systems, formulate training plans, strengthen assessments and keep training records
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Article 29 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall reasonably allocate and use facilities and equipment according to the characteristics of the products they produce, technological processes and production environment requirements, strengthen the management of facilities and equipment, and maintain their effective operation
.
Article 30 Medical device registrants and filers shall carry out conversion activities from design and development to production, and conduct sufficient verification and confirmation to ensure that the design and development output is suitable for production
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Article 31 Medical device registrants, filers, and entrusted manufacturers should strengthen procurement management, establish a supplier review system, evaluate suppliers, and ensure that purchased products and services meet relevant regulations
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Medical device registrants, filing parties, and entrusted manufacturing enterprises shall establish a raw material procurement acceptance record system to ensure that the relevant records are true, accurate, complete and traceable
.
Article 32 If the medical device registrant or filer entrusts the production, it shall evaluate the quality assurance ability and risk management ability of the entrusted party, and sign a quality agreement with the entrusted production quality agreement in accordance with the requirements of the State Drug Administration.
And the entrustment agreement, supervise the entrusted party to fulfill the obligations stipulated in the agreement
.
The entrusted production enterprise shall organize production in accordance with the requirements of laws, regulations, rules, medical device production quality management standards, mandatory standards, product technical requirements, entrusted production quality agreement, etc.
Supervision
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Article 33 Medical device registrants, filers, and entrusted manufacturers shall establish a record management system to ensure that the records are true, accurate, complete and traceable
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Encourage medical device registrants, filers, and entrusted production enterprises to adopt advanced technical means, establish an information management system, and strengthen the management of the production process
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Article 34 Medical device registrants and filers shall be responsible for product release, establish product release procedures, specify release standards and conditions, and review the medical device production process records and quality inspection results.
It can be listed only after the signature of the authorized release personnel
.
In the case of entrusted production, the medical device registrant and filer shall also review the production release documents of the entrusted manufacturer
.
The entrusted production enterprise shall establish production release procedures, clarify the standards and conditions for production release, and confirm that the standards and conditions are met before leaving the factory
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Those that do not comply with laws, regulations, rules, mandatory standards and the technical requirements of registered or filed products shall not be released from the factory or put on the market
.
Article 35 Medical device registrants and filers shall establish and implement a product traceability system to ensure product traceability
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The entrusted production enterprise shall assist the registrant and the filing party in implementing product traceability
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Article 36 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall carry out coding, data uploading, maintenance and updating in accordance with the relevant national requirements for implementing unique identification of medical devices to ensure the authenticity, accuracy, integrity and traceability of information
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Article 37 Medical device registrants, filers, and entrusted manufacturers shall establish corrective action procedures, determine the causes of problems, and take effective measures to prevent the recurrence of relevant problems
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Medical device registrants, filers, and entrusted manufacturers should establish preventive measures procedures, find out the causes of potential problems, and take effective measures to prevent problems from occurring
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Article 38 Medical device registrants and filers shall identify and control changes in raw materials and production processes that may affect product safety and effectiveness in accordance with the requirements of the medical device production quality management standards
.
If registration modification or recordation modification is required, relevant procedures shall be completed in accordance with the regulations on registration and recordation management
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Article 39 After the implementation of the new mandatory standards, medical device registrants and filers should identify the differences between product technical requirements and mandatory standards in a timely manner.
If registration changes or record-filing changes are required, they shall be handled in accordance with the regulations on registration and record-filing management.
related procedures
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Article 40 Medical device registrants, filing parties, and entrusted manufacturing enterprises shall implement adverse event monitoring responsibilities in accordance with the relevant regulations on medical device adverse event monitoring, carry out adverse event monitoring, and report to the medical device adverse event monitoring technical institution for investigation, analysis, evaluation, product risk control,
etc.
Article 41 If the medical device registrant or filer finds that the medical device produced does not meet the mandatory standards, the technical requirements of the registered or filed product, or has other defects, it shall immediately stop the production and notify the relevant operating enterprises and users.
Stop operation and use with consumers, recall medical devices that have been on the market, take measures such as remediation and destruction, record relevant situations, release relevant information, and report the recall and disposal of medical devices to the drug regulatory and health authorities
.
The entrusted manufacturer shall perform its responsibilities in accordance with the relevant provisions on medical device recall, and assist the medical device registrant and filer in recalling the medical device produced
.
Article 42 The medical device manufacturer shall report to the drug supervision and administration department about the product varieties it produces
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If the variety of production products is increased, it shall report to the original production license or production recordation department, and if it involves entrusted production, information such as the entrusting party, the entrusted production products, and the entrusted period shall also be provided.

.
If the increase in production of products by a medical device manufacturer involves changes in production conditions that may affect the safety and effectiveness of the products, it shall report to the original production licensing department 30 working days before the production of additional products, and the original production licensing department shall conduct on-site inspections in a timely manner
.
In the case of changes in licensing matters, relevant licensing changes shall be handled in accordance with regulations
.
Article 43 If a medical device manufacturer has suspended production for more than one year and has no similar products in production, it shall conduct necessary verification and confirmation when re-manufacturing, and report to the drug regulatory department in writing
.
If the quality and safety may be affected, the drug supervision and administration department may organize inspections as needed
.
Article 44 If the production conditions of medical device registrants, filers, or entrusted production enterprises change and no longer meet the requirements of the medical device quality management system, rectification measures should be taken immediately; if the safety and effectiveness of medical devices may be affected, they should be immediately Stop production activities and report to the original production license or production filing department
.
The entrusted manufacturer shall promptly notify the medical device registrant and filing person of the change
.
Article 45 Medical device registrants, filers, and entrusted manufacturers shall conduct self-inspection on the operation of the quality management system every year, and submit a self-inspection report to the local drug regulatory department before March 31 of the following year
.
Imported medical device registrants and filers shall submit self-inspection reports by their agents to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the agent is located
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Chapter IV Supervision and Inspection Article 46 The drug supervision and administration department shall supervise and inspect the production activities of medical device registrants, filers and entrusted production enterprises in accordance with the law
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When necessary, the drug regulatory department may carry out extended inspections on other units and individuals that provide products or services for medical device production activities.

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Article 47 The drug supervision and administration department shall establish and improve the professional and professional medical device inspector system, and according to the regulatory authority, industrial scale and inspection tasks, etc.
, allocate sufficient inspectors to effectively meet the needs of inspection work
.
Inspectors should be familiar with medical device laws and regulations, and have professional medical device knowledge and inspection skills
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Article 48 According to the risk level of products and enterprises, the drug supervision and administration department shall implement hierarchical management and dynamic adjustment of medical device registrants, recorders, and entrusted production enterprises
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The State Drug Administration organizes the formulation of a catalogue of key regulated products
.
The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall determine the catalogue of key products under supervision in their respective administrative regions in light of the actual situation
.
The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government organize the implementation of hierarchical supervision and management according to the catalogue of key products under supervision and the management status of medical device production quality, combined with factors such as medical device adverse events, product complaints and reports, and corporate credit status
.
Article 49 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate an annual medical device production supervision and inspection plan, determine the focus of medical device supervision and management, clarify the inspection frequency and coverage, and comprehensively apply supervision and inspection, key inspections, follow-up inspections, etc.
Strengthen supervision and management in various forms such as inspections and special inspections
.
Enterprises producing key supervised product catalogue varieties shall be inspected at least once a year
.
Article 50 When organizing supervision and inspection, the drug regulatory department shall formulate an inspection plan, clarify the inspection items and basis, truthfully record the on-site inspection situation, and notify the inspected enterprise in writing of the inspection result
.
If rectification is required, the rectification content and rectification period shall be clearly defined
.
When the drug supervision and administration department conducts supervision and inspection, it shall designate two or more inspectors to conduct supervision and inspection
.
Law enforcement personnel shall present their law enforcement certificates to the unit under inspection, and other inspectors shall present their inspector certificates or documents or certificates indicating their identities
.
Article 51 The drug supervision and administration department shall focus on the supervision and inspection of medical device registrants and recorders who produce them by themselves: (1) The implementation of laws and regulations and medical device production quality management standards by medical device registrants and recorders; (2) Organize production in accordance with mandatory standards and registered and filed product technical requirements, and the actual production is consistent with medical device registration and filing, medical device production license filing, etc.
; (3) Quality management system operation continues to be compliant and effective (4) The legal representative, the person in charge of the enterprise, the management representative and other personnel are familiar with the relevant laws and regulations of medical devices; (5) The performance of the management representative; (6) The legal representative, the person in charge of the enterprise, the manager Changes in representatives, quality inspection agencies or full-time personnel, production sites, environmental conditions, key production inspection equipment, etc.
; (7) Corrective and preventive measures for problems found in user feedback, internal audits, etc.
; (8) Sampling inspections, supervision and inspections of enterprise products (9) Internal audit, management review, change control, annual self-inspection report, etc.
; (10) Other contents that should be checked
.
Article 52 If the drug regulatory department adopts the entrusted production method for medical device registrants and filers, it shall focus on inspections when conducting supervision and inspection: (1) Medical device registrants and filers shall implement laws and regulations, and medical device production quality management practices.
(2) Whether the operation of the quality management system continues to be compliant and effective; (3) The performance of management representatives; (4) The organization of production in accordance with mandatory standards and registered or filed product technical requirements; (5) Users (6) Internal audit, management review, change control, annual self-inspection report, etc.
; (7) Carry out adverse event monitoring, re-evaluation, and product safety risk information collection and analysis (8) The listing release of the product; (9) The supervision of the entrusted production enterprise, the implementation of the quality agreement of the entrusted production, the design conversion and change control of the entrusted product, the production release of the entrusted product, etc.
; (10) Other contents that should be checked with emphasis
.
When necessary, inspections can be carried out on the entrusted production enterprises
.
Article 53 When conducting supervision and inspection of the entrusted production enterprises, the drug supervision and administration department shall focus on checking: (1) The actual production is consistent with the registration and filing of medical devices, the filing of medical device production licenses, etc.
; (2) The entrusted production enterprises enforce the law Regulations, medical device production quality management practices; (3) The legal representative, the person in charge of the enterprise, the management representative and other personnel are familiar with the relevant laws and regulations of medical devices; (4) The legal representative, the person in charge of the enterprise, the management representative, Changes in quality inspection institutions or full-time personnel, production sites, environmental conditions, key production inspection equipment, etc.
; (5) The production release of products; (6) The rectification and implementation of problems found in the company's product sampling inspection, supervision and inspection, complaints and reports; (7) Internal audit, management review, annual self-inspection report, etc.
; (8) Other contents that should be inspected
.
When necessary, inspections of medical device registrants and filers may be carried out
.
Article 54 If the drug regulatory department finds that there may be serious quality and safety risks in the monitoring of adverse events, random inspections, complaints and reports, etc.
, it shall conduct a cause-based inspection
.
In principle, inspections are conducted without prior notice
.
Article 55 The drug regulatory department shall conduct follow-up inspections on the rectification of enterprises
.
The follow-up inspection can conduct a written review of the rectification report submitted by the enterprise, and can also conduct an on-site review of the enterprise's problem rectification, responsibility implementation, corrective and preventive measures,
etc.
Article 56 If the medical device registrant and the entrusted manufacturer are not in the same province, autonomous region or municipality directly under the Central Government, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the medical device registrant is located shall be responsible for the operation of the registrant's quality management system, adverse event monitoring and product Carry out supervision and inspection on the fulfillment of statutory obligations such as recalls, and where relevant circumstances of the entrusted manufacturing enterprise are involved, the drug supervision and administration department at the place where the entrusted manufacturing enterprise is located shall cooperate
.
The drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the entrusted production enterprise is located shall be responsible for supervising and inspecting the production activities of the entrusted production enterprise.
If the relevant information of the registrant is involved, the drug regulatory department at the place where the registrant is located shall conduct supervision and inspection of the registrant
.
The medical device registrant and the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device registrant and the entrusted production enterprise are located shall respectively fulfill their territorial supervision responsibilities, establish a coordinated supervision mechanism, strengthen the communication of supervision information, and realize the effective connection of supervision
.
Article 57 The medical device registrant and the entrusted manufacturer are not in the same province, autonomous region, or municipality directly under the Central Government.
If the drug regulatory department of the province, autonomous region, or municipality where the medical device registrant or the entrusted manufacturer is located needs to conduct cross-regional inspections, joint inspections may be adopted.
, entrusted inspection, etc.

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Article 58 If the enterprise quality management system is found to be defective during the cross-regional inspection, the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device registrant and the entrusted production enterprise are located shall, according to their respective duties, urge the relevant enterprises to make timely rectification in strict accordance with the requirements.
, and report the inspection and rectification situation to the relevant drug supervision and administration departments in a timely manner
.
If the relevant problems found in the supervision and inspection of the entrusted manufacturing enterprise involve the registrant, it shall be notified to the drug regulatory department at the place where the registrant is located; if it is found that there may be medical device quality and safety risks, risk control measures shall be taken immediately, and the relevant information shall be notified to the place where the registrant is located.
Drug Administration
.
After receiving the notification, the drug regulatory department at the place where the registrant is located shall conduct analysis, research and judgment immediately and take corresponding risk control measures
.
If the registrant's supervision and inspection finds that the relevant problems involve the entrusted production enterprise, it shall notify the drug regulatory department at the place where the entrusted production enterprise is located, and jointly or entrust the drug regulatory department at the place where the entrusted production enterprise is located to conduct the inspection
.
Article 59 Where possible illegal acts are found in the cross-regional inspection, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device registrant and the entrusted production enterprise are located shall investigate and deal with them according to their respective duties
.
The handling of illegal acts shall be reported to the relevant drug supervision and administration departments in a timely manner
.
If cross-regional investigation and evidence collection are required, a joint investigation may be carried out with the relevant drug supervision and administration department at the same level, or a letter of assistance in investigation may be issued to ask the relevant drug supervision and administration department at the same level to assist in the investigation and collection of evidence
.
Article 60 If the filing and entrusted manufacturing enterprises of the first category of medical devices are not in the same districted city, and it is necessary to carry out cross-regional supervision and inspection and investigation and evidence collection according to their duties according to the law, refer to Articles 56 to 59 of these Measures.
implementation of the regulations
.
Article 61 The registrant and filer of imported medical devices shall designate a domestic enterprise legal person as an agent, and the agent shall assist the registrant and filer in fulfilling the obligations stipulated in the Regulations on the Supervision and Administration of Medical Devices and these Measures
.
Article 62 The production of imported medical devices shall meet the relevant requirements for the production of medical devices in China and be subject to overseas inspections organized by the State Drug Administration
.
The agent is responsible for coordinating and cooperating with overseas inspections
.
Imported medical device registrants, filers, and agents refuse, obstruct, delay, or evade overseas inspections organized by the State Drug Administration, resulting in the inability to carry out inspections and the inability to confirm the effective operation of the quality management system, which is evidence that may endanger human health The State Drug Administration may handle the situation in accordance with the provisions of Article 72, paragraph 2, of the Regulations on the Supervision and Administration of Medical Devices
.
Article 63 When conducting on-site inspections, the drug regulatory department may conduct random inspections as needed
.
Article 64 If the medical device produced causes harm to the human body or there is evidence that it may endanger human health, the drug supervision and administration department may take emergency control measures to suspend production, import, operation and use, and issue safety warning information
.
During the supervision and inspection, it is found that the production activities seriously violate the medical device production quality management regulations, cannot guarantee the safety and effectiveness of the products, and may endanger human health, and shall be dealt with in accordance with the provisions of the preceding paragraph
.
Article 65 The drug regulatory department shall regularly organize risk consultations, analyze and evaluate the quality and safety risks of medical devices within its jurisdiction, and take corresponding risk control measures in a timely manner
.
Article 66 If the medical device registrant, filing person, and entrusted production enterprise fail to take effective measures to eliminate the existing medical device quality and safety risks, the drug regulatory department may take a The legal representative or the person in charge of the enterprise shall conduct responsibility interviews
.
If it involves cross-regional entrusted production, the situation of the interview shall be reported to the relevant drug supervision and administration department
.
Article 67 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall establish and timely update the credit files of Class II and Class III medical device registrants and entrusted production enterprises within their jurisdictions, and the departments responsible for drug supervision and administration at the city level with districts The credit files of the first-class medical device filer and the entrusted production enterprise within the jurisdiction shall be established and updated in a timely manner in accordance with their duties and responsibilities
.
The credit file shall include information such as the filing of production licenses, the variety of products produced, commissioned production, the results of supervision and inspection, the investigation and punishment of illegal acts, random quality inspections, records of bad behavior, and complaints and reports
.
For medical device registrants, filings, and entrusted manufacturing enterprises with bad credit records, the drug regulatory department shall increase the frequency of supervision and inspection, and strengthen punishments for dishonesty in accordance with the law
.
Article 68 The drug supervision and administration department shall record the variety of products produced by the enterprise in the credit file
.
The entrusted manufacturer increases the production of Class II and Class III medical devices and is not in the same province, autonomous region or municipality as the product registrant, or increases the production of Class I medical devices and is not in the same districted city as the product registrant If the entrusted production enterprise is located, the drug supervision and administration department at the place where the entrusted production enterprise is located shall also notify the relevant information to the drug supervision and administration department at the place where the registrant or filing person is located
.
Article 69 The drug regulatory department shall publish the contact information for accepting complaints and reports
.
The drug regulatory department that receives the report shall verify, handle and reply in a timely manner
.
If verified, the whistleblower shall be rewarded in accordance with relevant regulations
.
Article 70 During the supervision and inspection, the drug supervision and administration department shall collect and fix evidence in a timely manner if it finds suspected illegal acts, and file a case for investigation and punishment according to law; if a crime is suspected, it shall be handed over to the public security organ for handling in a timely manner
.
Article 71 The drug regulatory department and its staff shall keep confidential the business secrets learned during the investigation and inspection.

.
Article 72 During the supervision and inspection, the drug supervision and administration department and its staff shall strictly enforce the law in a fair and civilized manner, strictly enforce the discipline of clean government, shall not ask for or accept property, shall not seek other interests, and shall not hinder the normal production activities of enterprises
.
Chapter V Legal Responsibilities Article 73 For illegal acts in the production of medical devices, if the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations have already stipulated, the regulations shall be followed
.
Article 74 Any of the following circumstances shall be punished in accordance with the provisions of Article 81 of the Regulations on the Supervision and Administration of Medical Devices: (1) Production of Class II and Class III medical products beyond the production scope specified in the medical device production license (2) Production of Class II and Class III medical devices in unlicensed production sites; (3) Continuing to engage in Class II and Class III medical devices without going through the renewal procedures according to law after the expiration of the medical device production license (4) If a medical device manufacturer increases the variety of products it produces, it should go through the licensing changes in accordance with the law but fails to do so
.
Article 75 Those who fail to handle the modification of the production record of Class I medical devices in accordance with the provisions of these Measures shall be dealt with in accordance with the provisions of Article 84 of the Regulations on the Supervision and Administration of Medical Devices
.
Article 76 Those who violate the medical device production quality management regulations and fail to establish a quality management system and maintain effective operation shall be ordered by the drug supervision and administration department to make corrections within a time limit according to their duties; those that affect the safety and effectiveness of medical device products shall be subject to the regulations on the supervision and management of medical devices.
Article 86 stipulates the punishment
.
Article 77 Violating the provisions of paragraph 2 of Article 15 and paragraph 3 of Article 42 of these Measures, changes in production conditions that may affect the safety and effectiveness of products, and production without reporting in accordance with regulations, shall be subject to medical device supervision Penalties stipulated in Article 88 of the Administrative Regulations
.
Article 78 Under any of the following circumstances, the drug supervision and administration department shall give a warning according to its duties and impose a fine of more than 10,000 yuan but not more than 50,000 yuan: (1) The medical device manufacturer fails to comply with Article 42 of these Measures.
(2) The production has been discontinued for more than one year and no similar products are in production, and the necessary verification and confirmation are not carried out when re-producing and reporting to the locality reported by the drug regulatory authority
.
Article 79 Under any of the following circumstances, the drug supervision and administration department shall order it to make corrections within a time limit according to its duties; if it refuses to make corrections, a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; if the circumstances are serious, it shall be imposed a fine of not less than 50,000 yuan but not more than 100,000 yuan.
A fine of less than RMB 100 shall be imposed: (1) Failure to change the registration items of the medical device production license in accordance with the provisions of Article 16 of these Measures; and maintenance updates
.
Article 80 Any staff member of the drug regulatory department who violates the provisions of these Measures, abuses their powers, neglects their duties, or engages in favoritism and fraud shall be punished according to law
.
Chapter VI Supplementary Provisions Article 81 These Measures shall come into force on May 1, 2022
.
On July 30, 2014, the "Measures for the Supervision and Administration of Medical Device Production" promulgated by Order No.
7 of the former State Food and Drug Administration shall be repealed at the same time
.
Measures for the Supervision and Administration of Medical Device Operation Chapter 1 General Provisions Article 1 In order to strengthen the supervision and management of medical device operation, standardize medical device operation activities, and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices
.
Article 2 Those engaged in medical device business activities and their supervision and administration within the territory of the People's Republic of China shall abide by these Measures
.
Article 3 To engage in medical device business activities, it shall abide by the requirements of laws, regulations, rules, mandatory standards and medical device business quality management specifications, and ensure that the information in the medical device business process is true, accurate, complete and traceable
.
Medical device registrants and filers can sell them by themselves, or they can entrust medical device business enterprises to sell their registered and filed medical devices
.
Article 4 According to the degree of risk of medical devices, the operation of medical devices shall be subject to classified management
.
The operation of Class III medical devices is subject to licensing management, the operation of Class II medical devices is subject to recordation management, and the operation of Class I medical devices does not require license and recordation
.
Article 5 The State Drug Administration shall be in charge of the supervision and administration of the national medical device operation
.
The drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the supervision and administration of medical device business within their respective administrative regions
.
The departments in charge of drug supervision and administration at the city and county levels divided into districts shall be responsible for the supervision and administration of medical device operation within their respective administrative regions
.
Article 6 The medical device inspection, inspection, monitoring and evaluation and other professional technical institutions established or designated by the drug regulatory department in accordance with the law shall undertake relevant technical work and issue technical opinions according to the division of responsibilities, and provide technical support for the supervision and management of medical device operation
.
Article 7 The State Drug Administration shall strengthen the informatization construction of medical device business supervision and management, and improve the level of online government services
.
The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the information construction and management of medical device business supervision and management in their respective administrative regions, and coordinate and promote the sharing of medical device business supervision and management information in accordance with the requirements of the State Drug Administration
.
Article 8 The drug regulatory department shall promptly disclose information such as medical device business license and filing, as well as the results of supervision and inspection and administrative punishment in accordance with the law, so as to facilitate public inquiries and accept social supervision.

.
Chapter II Business Licensing and Filing Management Article 9 To engage in medical device business activities, the following conditions shall be met: (1) Quality management institutions or quality management personnel suitable for the business scope and business scale, and the quality management personnel shall have relevant professional qualifications or professional title; (2) The business premises suitable for the business scope and business scale; (3) The storage conditions suitable for the business scope and business scale; (4) The quality management system suitable for the operating medical devices; (5) ) Quality management institutions or personnel for professional guidance, technical training and after-sales service that are compatible with the operating medical devices
.
Enterprises engaged in the business of Class III medical devices shall also have a computer information management system that meets the requirements of the medical device business quality management system to ensure the traceability of the products they operate
.
Enterprises engaged in the operation of Class I and Class II medical devices are encouraged to establish a computer information management system that meets the requirements of the quality management system for medical device operations
.
Article 10 To engage in the business of Class III medical devices, the business enterprise shall file an application with the department in charge of drug supervision and administration at the districted city level, and submit the following materials: (1) Legal representative (person in charge of the enterprise), responsible for quality (2) The organization and department setting of the enterprise; (3) The business scope and mode of operation of medical devices; (4) The geographical location map, floor plan, and property rights documents of the business premises and warehouse Or a photocopy of the lease agreement; (5) Catalogue of main operating facilities and equipment; (6) Catalogue of documents such as the operation quality management system and work procedures; (7) Basic information of the information management system; (8) Authorization documents of the handler
.
An applicant for a medical device business license shall ensure that the submitted information is legal, true, accurate, complete and traceable
.
Article 11 After receiving the application, the department in charge of drug supervision and administration at the city level with districts shall deal with the application according to the following circumstances: (1) The application matters are within the scope of the authority of the administrative organ, and if the application materials are complete and conform to the statutory form, the application shall be handled according to the following circumstances: Accept the application; (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 statutory form, the applicant shall be notified on the spot or within 5 working days at one time All that needs to be corrected
.
If the application is not notified within the time limit, it will be accepted from the date of receipt of the application materials; (4) If the application matters do not fall within the scope of the administrative organ's powers and powers, it shall immediately make a decision not to accept the application, and inform the applicant to apply to the relevant administrative department
.
If the department in charge of drug supervision and administration at the city level with districts accepts or rejects an application for a medical device business license, it shall issue a notice of acceptance or rejection affixed with the special seal of the administrative organ and dated
.
Article 12 For matters that are required to be heard for the implementation of administrative licensing as stipulated by laws, regulations and rules, or other major administrative licensing matters involving public interests that the drug regulatory department deems to require a hearing, the drug regulatory department shall announce to the public and hold a hearing
.
Where an application for a medical device business license directly involves a major interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties that they have the right to request a hearing before making an administrative licensing decision
.
Article 13 The department in charge of drug supervision and administration at the city level with districts shall, after accepting the application for business license, examine the application materials, and if necessary, carry out on-site inspection in accordance with the requirements of the quality management standard for medical device business, and from the date of acceptance A decision will be made within 20 working days
.
If rectification is required, the rectification time is not included in the review time limit
.
If the prescribed conditions are met, a written decision to grant the license will be made, and a medical device business license will be issued within 10 working days; if the prescribed conditions are not met, a written decision of disapproval will be made, and the reasons
.
Article 14 The medical device business license is valid for 5 years, indicating the license number, enterprise name, unified social credit code, legal representative, person in charge of the enterprise, domicile, business place, business method, business scope, warehouse address, Matters such as issuing department, issuing date and validity period
.
The medical device business license shall be uniformly formatted by the State Drug Administration and printed by the department in charge of drug supervision and administration at the municipal level divided into districts
.
The electronic certificate of the medical device business license produced by the drug regulatory department has the same legal effect as the paper certificate
.
Article 15 If the medical device business license is changed, an application for the modification of the medical device business license shall be submitted to the original license-issuing department, and the relevant materials related to the changed content as stipulated in Article 10 of these Measures shall be submitted
.
In the event of a change of business premises, business mode, business scope, and warehouse address, the drug regulatory department shall make a decision to approve or not to change within 20 working days from the date of acceptance
.
If necessary, conduct on-site inspections in accordance with the requirements of the medical device business quality management standards
.
If rectification is required, the rectification time is not included in the review time limit
.
If no change is made, the reasons shall be explained in writing and the applicant shall be informed
.
If other matters are changed, the drug supervision and administration department shall make changes on the spot
.
The number and validity period of the changed medical device business license remain unchanged
.
Article 16 If the validity period of the medical device business license needs to be renewed, the medical device business enterprise shall file a renewal application within 90 working days to 30 working days before the validity period expires
.
If the renewal application is not submitted within the time limit, the renewal application will not be accepted
.
The original license-issuing department shall review the renewal application in accordance with the provisions of Article 13 of these Measures, conduct on-site inspection if necessary, and make a decision on whether to approve the renewal before the expiration of the medical device business license.

.
If it meets the prescribed conditions after review, the extension will be granted, and the number of the extended medical device business license will remain unchanged
.
Those who do not meet the prescribed conditions shall be ordered to rectify within a time limit; those who still do not meet the prescribed conditions after rectification shall not be renewed, and the reasons shall be explained in writing
.
If a decision is not made within the time limit, it shall be deemed to be granted a continuation
.
If the approval time for the renewal of the license is within the validity period of the original license, the start date of the renewal shall be the day following the expiry date of the original license; if the approval time is not within the validity period of the original license, the start date of the renewal shall be the date on which the renewal of the license is approved
.
Article 17 If a business enterprise sets up warehouses in a city divided into districts, the medical device business license issuing department or the filing department shall notify the department in charge of drug supervision and administration in the city divided into districts where the warehouse is located
.
Article 18 If a business enterprise establishes a new independent business place, it shall separately apply for a medical device business license or record it according to law
.
Article 19 If the medical device business license is lost, an application shall be submitted to the original license-issuing department for reissuance
.
The original license-issuing department shall reissue the medical device business license in a timely manner, and the number and validity period of the reissued medical device business license shall be consistent with the original license
.
Article 20 Under any of the following circumstances, the original license-issuing department shall cancel the medical device business license according to law, and make an announcement: (1) Those who apply for cancellation on their own initiative; (2) Those whose validity period expires but not renewed; (3) Market players The qualification is terminated in accordance with the law; (4) The medical device business license is revoked or revoked in accordance with the law; (5) Other circumstances under which the administrative license should be cancelled according to laws and regulations
.
Article 21 To engage in the business of Class II medical devices, the business enterprise shall file with the department in charge of drug supervision and administration at the city divided into districts where it is located, and submit materials that comply with Article 10 of these Measures (except for item 7), That is, the operation record is completed and the operation record number is obtained
.
The recorder of medical device business shall ensure that the submitted information is legal, true, accurate, complete and traceable
.
Article 22 When necessary, the department in charge of drug supervision and administration at the city level with districts shall, within 3 months from the date of completion of the filing, conduct on-site inspections of the submitted materials and the implementation of the quality management practices for medical device business
.
If the on-site inspection finds that it is inconsistent with the submitted materials or does not meet the requirements of the medical device business quality management standard, it shall be ordered to make corrections within a time limit; if the product safety and effectiveness cannot be guaranteed, the filing shall be cancelled and an announcement shall be made to the public
.
Article 23 Those who apply for a Class III medical device business license and conduct a Class II medical device business record at the same time, or have obtained a Class III medical device business license for a Class II medical device record, may be exempted from submitting the corresponding materials
.
Article 24 If the business premises, business mode, business scope, warehouse address, etc.
of the second-class medical device business enterprise change, it shall make a record change in a timely manner
.
When necessary, the department responsible for drug supervision and administration at the city level with districts shall conduct on-site inspections
.
If the on-site inspection does not meet the requirements of the medical device business quality management standard, it will be ordered to make corrections within a time limit; if the product safety and effectiveness cannot be guaranteed, the recordation will be cancelled and an announcement will be made to the public
.
Article 25 Class II medical devices whose product safety and effectiveness are not affected by the circulation process may be exempted from business filing
.
The specific product list shall be formulated, adjusted and published by the State Drug Administration
.
Article 26 Institutions engaged in the storage, allocation and supply of non-profit contraceptive medical devices shall comply with relevant regulations and do not need to apply for a medical device business license or record
.
Article 27 Medical device registrants and filers who sell their registered and filed medical devices at their domicile or production address do not need to apply for a medical device business license or filing, but shall meet the prescribed business conditions; store and sell them in other places For medical devices, the medical device business license or filing shall be handled in accordance with the regulations
.
Article 28 No unit or individual may forge, alter, trade, lease or lend a medical device business license
.
Chapter III Operation Quality Management Article 29 When engaged in the operation of medical devices, a quality management system covering the whole process of procurement, acceptance, storage, sales, transportation, and after-sales service shall be established in accordance with the requirements of laws and regulations and the requirements of quality management standards for medical device operation.
System and quality control measures, and make relevant records to ensure that operating conditions and operating activities continue to meet the requirements
.
Article 30 Medical device business enterprises shall establish and implement a product traceability system to ensure product traceability
.
Medical device business enterprises shall implement the unique identification system for medical devices in accordance with relevant state regulations
.
Article 31 A medical device operating enterprise shall purchase medical devices from legally qualified medical device registrants, record holders and operating enterprises
.
Article 32 A medical device operating enterprise shall establish a purchase inspection record system, and when purchasing medical devices, it shall inspect the qualifications of the supplier, as well as the medical device registration certificate and filing information, and qualification certificates
.
The incoming inspection records shall be true, accurate, complete and traceable
.
The incoming inspection records include: (1) The name, model, specification and quantity of the medical device; (2) The registration certificate number or filing number of the medical device; (3) The name and production license of the medical device registrant, filing and entrusted manufacturer (4) The production batch number or serial number, use period or expiration date, purchase date, etc.
of the medical device; (5) The name, address and contact information of the supplier
.
The incoming inspection records shall be kept for 2 years after the expiration date of the medical device; if there is no validity period, it shall not be less than 5 years
.
Implantable medical device purchase inspection records shall be kept
.
Article 33 Medical device business enterprises shall take effective measures to ensure that the transportation and storage of medical devices meet the requirements of medical device instructions or labels, and make corresponding records
.
If there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices
.
Article 34 If the medical device registrant, filing and operating enterprise entrusts other units to transport and store medical devices, they shall evaluate the quality assurance capability of the entrusted party in transporting and storing medical devices, and sign an entrustment agreement with them, specifying the transportation, Quality responsibility during storage to ensure quality safety during transportation and storage
.
Article 35 Those who specially provide transportation and storage services for medical device registrants, filers and operating enterprises shall sign a written agreement with the entrusting party, clarifying the rights, obligations and quality responsibilities of both parties, and have the conditions and scale of product transportation and storage.
Appropriate equipment and facilities, with information management platform and technical means to carry out real-time electronic data exchange with the entrusting party and realize the traceability of the whole process of product operation and quality management
.
Article 36 If a medical device registrant or filing person entrusts sales, it shall entrust a qualified medical device operating enterprise, and sign an entrustment agreement to clarify the rights and obligations of both parties
.
Article 37 Medical device registrants, filing and operating enterprises shall strengthen the training and management of sales personnel, and bear legal responsibility for the purchase and sale of medical devices by sales personnel in the name of the enterprise
.
Article 38 The operating enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices shall establish a sales record system
.
The sales record information shall be true, accurate, complete and traceable
.
The sales records include: (1) The name, model, specification, registration certificate number or filing number, quantity, unit price, and amount of the medical device; (2) The production batch number or serial number, use period or expiration date, and sales date of the medical device; (3) Names, production license numbers or filing numbers of medical device registrants, filing and entrusted manufacturing enterprises
.
For enterprises engaged in the wholesale business of Class II and Class III medical devices, the sales records shall also include the purchaser's name, address, contact information, relevant license document number or filing number,
etc.
The sales records shall be kept for 2 years after the expiration of the validity period of the medical device; if there is no validity period, it shall not be less than 5 years
.
Implantable medical device sales records shall be kept
.
Article 39 Medical device business enterprises shall provide after-sales service
.
If it is agreed that the supplier or other organization will provide after-sales service, the operating enterprise shall strengthen management to ensure the safe use of medical devices after sales
.
Article 40 The medical device business enterprise shall assign full-time or part-time personnel to be responsible for after-sales management, find out the reasons for the quality problems complained by customers, take effective measures to deal with and give feedback in a timely manner, keep records, and promptly notify the medical device registrant when necessary , filing person, production and operation enterprises
.
Article 41 A medical device operating enterprise shall assist the medical device registrant and filer to monitor the adverse events of the medical devices it operates, and report to the medical device adverse event monitoring technical institution in accordance with the provisions of the State Drug Administration
.
Article 42 If a medical device operating enterprise finds that the medical device it operates does not meet the mandatory standards, the technical requirements for registered or filed products, or has other defects, it shall immediately stop the operation and notify the medical device registrant, recorder, etc.
Relevant units, and record the cessation of operations and notification
.
If the medical device registrant or filing party thinks it needs to be recalled, it should be recalled immediately
.
Article 43 A Class III medical device business enterprise that has been suspended for more than one year shall conduct necessary verification and confirmation before resuming business operations, and shall report in writing to the department in charge of drug supervision and administration at the city divided into districts where it is located
.
If the quality and safety may be affected, the drug supervision and administration department may organize inspections as needed
.
If the operating conditions of medical device registrants, filers, or operating enterprises have undergone major changes and no longer meet the requirements of the medical device business quality management system, rectification measures should be taken immediately; if the safety and effectiveness of medical devices may be affected, business activities should be stopped immediately, and Report to the original business license or filing department
.
Article 44 The medical device business enterprise shall establish a quality management self-inspection system, conduct self-inspection in accordance with the requirements of the medical device business quality management standard, and submit the previous year's report to the local city and county-level drug supervision and management department before March 31 each year.
Self-examination report
.
Article 45 Those engaged in medical device business activities shall not operate medical devices that have not been registered or filed in accordance with the law, have no qualified certification documents, and have expired, expired or eliminated
.
It is prohibited to import and sell expired, expired, obsolete and other used medical devices
.
Chapter IV Supervision and Inspection Article 46 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government shall organize the supervision and inspection of the supervision and management of the medical device business in their respective administrative regions
.
The departments responsible for drug supervision and administration at the city and county levels divided into districts shall be responsible for the supervision and inspection of medical device business activities in their respective administrative regions
.
Article 47 According to the quality management of medical device operating enterprises and the risk level of the medical device products, the drug regulatory department shall implement classified and hierarchical management and make dynamic adjustments
.
Article 48 The departments responsible for drug supervision and administration at the city and county levels divided into districts shall formulate an annual inspection plan, clarify the focus of supervision, inspection frequency and coverage, and organize the implementation
.
Article 49 The drug supervision and administration department organizes supervision and inspection.
In principle, the inspection method shall adopt surprise supervision and inspection.
There shall be no less than two people during the on-site inspection, and the law enforcement certificate shall be presented, and the on-site inspection situation shall be truthfully recorded
.
If the inspection finds that there are quality and safety risks or does not meet the requirements of the specification, the inspection result shall be notified in writing to the inspected enterprise
.
If rectification is required, the rectification content and rectification period shall be clearly defined, and follow-up inspection shall be carried out
.
Article 50 The departments in charge of drug supervision and administration at the city and county levels divided into districts shall supervise and inspect the medical device business enterprises' compliance with the requirements of the medical device business quality management standard, and urge them to standardize their business activities
.
Article 51 The departments in charge of drug supervision and administration at the city and county levels divided into districts shall strengthen supervision and inspection in light of the situation reflected in the annual self-inspection reports submitted by medical device business enterprises
.
Article 52 The drug supervision and administration department shall conduct key supervision and inspection on the following circumstances: (1) Serious problems were found in the supervision and inspection of the previous year; (2) Administrative penalties were imposed for violating relevant laws and regulations; ( 3) The key inspection enterprises determined by the risk consultation; (4) Those with bad credit records; (5) Newly established medical device wholesale enterprises and third-class medical device retail enterprises whose operating conditions have undergone major changes; (6) For other Medical device registrants, filers, and production and operation enterprises that provide storage and transportation services; (7) Other situations that require key supervision and inspection
.
Article 53 If the drug supervision and administration department finds that there may be serious quality and safety risks in adverse event monitoring, random inspection, complaints and reports, etc.
, in principle, it shall conduct a cause-based inspection
.
In principle, inspections are conducted without prior notice
.
Article 54 According to the needs of medical device quality and safety risk prevention and control, the drug regulatory department may conduct extended inspections on other relevant units and individuals that provide products or services for medical device business activities
.
Article 55 The warehouses set up by medical device operating enterprises in cities with districts shall be supervised and inspected by the drug supervision and administration department where the warehouses are located
.
The drug regulatory department where the medical device business enterprise is located and the drug regulatory department where the warehouse is located shall strengthen the sharing of regulatory information, and may conduct joint inspections when necessary
.
Article 56 The drug supervision and administration department shall strengthen the random inspection of medical device business links, and shall promptly dispose of those that fail the random inspection and inspection
.
The drug regulatory authorities at or above the provincial level shall issue medical device quality announcements in a timely manner based on the results of random inspections
.
Article 57 If the medical devices in operation cause harm to the human body or there is evidence to prove that it may endanger human health, the drug supervision and administration department may take emergency control measures to suspend import, operation and use, and issue safety warning information
.
During the supervision and inspection, it is found that the business activities seriously violate the medical device business quality management regulations, cannot guarantee the safety and effectiveness of the products, and may endanger human health, and shall be dealt with in accordance with the provisions of the preceding paragraph
.
Article 58 The drug regulatory department shall conduct regular risk consultations, research and judgments based on the supervision and inspection, product sampling inspection, adverse event monitoring, complaints and reports, and administrative penalties, and do a good job in the investigation, prevention and control of medical device quality and safety hazards
.
Article 59 If the medical device registrant, filing person, and operating enterprise fail to take effective measures to eliminate the existing medical device quality and safety risks, the drug regulatory department may issue a legal representative of the medical device registrant, filing person, and operating enterprise to the medical device.
The person or the person in charge of the enterprise conducts a responsibility interview
.
Article 60 The department in charge of drug supervision and administration at the city level with districts shall establish and timely update the credit files of medical device business enterprises within its jurisdiction
.
The credit file shall include information such as the license filing of the medical device business enterprise, the results of supervision and inspection, the investigation and punishment of illegal acts, quality random inspections, self-inspection reports, records of bad behaviors, and complaints and reports
.
For medical device registrants, filings, and operating enterprises with bad credit records, the drug regulatory department shall increase the frequency of supervision and inspection, and strengthen punishments for dishonesty in accordance with the law
.
Article 61 The drug regulatory department shall publish the contact information for accepting complaints and reports
.
The drug regulatory department that receives the report shall verify, handle and reply in a timely manner
.
If verified, the whistleblower shall be rewarded in accordance with relevant regulations
.
Article 62 During the supervision and inspection, the drug supervision and administration department shall collect and fix evidence in a timely manner if it finds suspected illegal acts, and file a case for investigation and punishment according to law; if a crime is suspected, it shall be handed over to the public security organ for handling in a timely manner
.
Article 63 The drug regulatory department and its staff shall keep confidential the business secrets learned during the investigation and inspection
.
Article 64 During the supervision and inspection, the drug supervision and administration department and its staff shall strictly regulate the law in a fair and civilized manner, strictly enforce the discipline of clean government, shall not ask for or accept property, shall not seek other interests, and shall not hinder the normal business activities of the enterprise
.
Chapter V Legal Responsibilities Article 65 For the illegal acts of medical device business, if there are provisions in laws and regulations such as the Regulations on the Supervision and Administration of Medical Devices, the provisions shall be followed
.
Article 66 Anyone who falls under any of the following circumstances shall be ordered to make corrections within a time limit, and a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; if the circumstances are serious, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if harmful consequences are caused, a fine of 10 yuan shall be imposed.
A fine of more than 10,000 yuan but not more than 200,000 yuan: (1) The third-class medical device business enterprise changes its business location, business scope, business method, and warehouse address without authorization; (2) After the medical device business license expires, it fails to go through the renewal procedures according to law.
Continue to engage in medical device business activities
.
Those who engage in the business activities of Class III medical devices without permission shall be punished in accordance with Article 81 of the Regulations on the Supervision and Administration of Medical Devices
.
Article 67 Anyone who violates the relevant requirements of the medical device business quality management regulations shall be ordered by the drug regulatory department to make corrections within a time limit; those that affect the safety and effectiveness of medical device products shall be punished in accordance with the provisions of Article 86 of the Regulations on the Supervision and Administration of Medical Devices
.
Article 68 If a medical device business enterprise fails to submit the annual self-inspection report of the quality management system as required, or violates the provisions of these Measures to provide storage and transportation services for other medical device production and business enterprises, the drug regulatory department shall order it to make corrections within a time limit; Those who refuse to make corrections shall be fined not less than 10,000 yuan but not more than 50,000 yuan; if the circumstances are serious, they shall be fined not less than 50,000 yuan but not more than 100,000 yuan
.
Article 69 If a Class III medical device operating enterprise fails to change the enterprise name, legal representative and person in charge in accordance with the provisions of these Measures, the drug regulatory department shall order it to make corrections within a time limit; if it refuses to make corrections, it shall be fined more than 5,000 yuan 3 A fine of less than 10,000 yuan
.
Article 70 Any staff member of the drug regulatory department who violates the provisions of these Measures, abuses their powers, neglects their duties, or engages in favoritism and fraud shall be punished according to law
.
Chapter VI Supplementary Provisions Article 71 The meanings of the following terms in these Measures are: Wholesale of medical devices refers to the sale of medical devices to medical device manufacturers, medical device dealers, medical device users or other units that have reasonable needs for use business behavior of medical devices
.
Medical device retailing refers to the medical device business behavior of directly selling medical devices to consumers for personal use
.
Article 72 Those engaged in online sales of medical devices shall abide by the relevant provisions of laws, regulations and rules
.
Article 73 These Measures shall come into force on May 1, 2022
.
On July 30, 2014, the "Measures for the Supervision and Administration of Medical Device Operation" promulgated by the former State Food and Drug Administration Order No.
8 shall be repealed at the same time
.