The two ministries jointly issued the "Quality Management Specification for Clinical Trials of Medical Devices"

On March 31, the State Food and Drug Administration issued an announcement stating that in order to deepen the reform of the medical device review and approval system and strengthen the management of clinical trials of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" (Order No.
739 of the State Council) and "Medical Device Registration" Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No.
47 of the State Administration for Market Regulation) and Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No.
48 of the State Administration for Market Regulation), the State Drug Administration and the National Health Commission organized the revision of the Medical The Good Management Practice for Device Clinical Trials, is hereby promulgated and will come into force on May 1, 2022
.
Chapter 1 General Provisions of the Good Clinical Trials for Medical Devices Article 1 In order to strengthen the management of clinical trials of medical devices, safeguard the rights and safety of subjects, and ensure that the clinical trials of medical devices are standardized and the results are true, accurate, complete and traceable, This specification is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices
.
Article 2 Within the territory of the People's Republic of China, activities related to clinical trials of medical devices for the purpose of applying for the registration of medical devices (including in vitro diagnostic reagents, the same below) shall comply with this specification
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This specification covers the whole process of clinical trials of medical devices, including the design, implementation, supervision, inspection, and inspection of clinical trials of medical devices, as well as data collection, recording, storage, analysis, summarization, and reporting
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Article 3 Clinical trials of medical devices shall abide by the ethical guidelines of the Declaration of Helsinki of the World Medical Congress and the relevant norms of national biomedical research ethics involving human beings
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All parties involved in clinical trials of medical devices shall bear corresponding ethical responsibilities in accordance with their respective responsibilities in the trials
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Article 4 The implementation of clinical trials of medical devices shall have sufficient scientific basis and clear trial objectives, and weigh the risks and benefits expected by subjects and society
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Clinical trials should be implemented or continued only when the expected benefits outweigh the risks
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Article 5 Clinical trials of medical devices shall be carried out in medical device clinical trial institutions that have the corresponding conditions and are filed in accordance with regulations
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Article 6 Clinical trials of medical devices shall obtain the consent of the ethics committee
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Those included in the catalogue of Class III medical devices subject to clinical trial approval shall also be approved by the State Drug Administration, and clinical trials shall be conducted in Class III A medical institutions that meet the requirements
.
Article 7 The sponsor of a clinical trial of medical devices shall establish a quality management system covering the whole process of clinical trials of medical devices, to ensure that clinical trials of medical devices comply with relevant laws and regulations, and to protect the rights and safety of subjects
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Chapter 2 Ethics Committee Article 8 The duties of the ethics committee are to protect the legitimate rights and interests and safety of the subjects and maintain the dignity of the subjects
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Article 9 The ethics committee shall abide by the ethical guidelines of the Declaration of Helsinki of the World Medical Congress and relevant laws and regulations
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The composition, operation and filing management of the ethics committee shall meet the requirements of the health management department
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Article 10 All members of the ethics committee shall receive training in ethical knowledge, this code and relevant laws and regulations, be familiar with the ethics guidelines and relevant laws and regulations for clinical trials of medical devices, and abide by the work procedures of the ethics committee
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Article 11 Before the start of a clinical trial of a medical device, the sponsor shall submit the following documents to the ethics committee through the principal investigator: (1) Clinical trial protocol; (2) Investigator's manual; (3) The text of the informed consent and any other documents provided Written materials to subjects; (4) Procedural documents for recruiting subjects and publicizing them (if applicable); (5) Text of case report form; (6) Product inspection report based on product technical requirements; (7) ) Preclinical research related materials; (8) The principal investigator's resume, professional expertise, ability, training and other documents that can prove his qualifications; (9) The development of the experimental medical device meets the relevant requirements of the applicable medical device quality management system Statement; (10) Other documents related to ethical review
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Article 12 The ethics committee shall review the ethics and scientificity of clinical trials of medical devices, and shall focus on the following contents: (1) The qualifications and experience of the principal investigator and whether there is sufficient time to participate in the clinical trial; ( 2) Whether the staffing and equipment conditions of the clinical trial meet the requirements of the trial; (3) Whether the degree of risk that the subjects may suffer is appropriate compared with the expected benefits of the trial; (4) Whether the clinical trial protocol fully considers the ethical principles, Whether it is scientific, including whether the research purpose is appropriate, whether the rights and safety of the subjects are guaranteed, and whether the risks that other personnel may suffer are adequately protected; (5) Whether the information provided to the subjects about the trial is complete , whether they are clearly informed of their rights; whether the subjects can understand the content of the informed consent; whether the method for obtaining the informed consent is appropriate; (6) Whether the subject selection and exclusion are scientific and fair; Whether the subjects receive reasonable compensation for participating in the clinical trial; if the subject suffers injury or death related to the clinical trial, is the diagnosis, treatment and safeguard measures adequate; (8) For children, pregnant women, the elderly, mentally retarded, mentally Whether the protection of subjects in special populations such as patients with disabilities is adequate
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Article 13 The review opinion of the ethics committee can be: (1) Agree; (2) Agree with necessary modifications; (3) Disagree; (4) Suspend or terminate the consented experiment
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If the review opinion requires revision or denial, the reasons shall be explained
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Article 14 The informed consent form shall generally include the following contents and descriptions of matters: (1) The name of the principal investigator and relevant information; (2) The name of the medical device clinical trial institution; (3) The name, purpose, Method and content; (4) Process and duration of the clinical trial; (5) Funding sources of the clinical trial and possible conflicts of interest; (6) The possible benefits of the expected subjects and the known and foreseeable risks and possible occurrences Adverse events; (7) Information on alternative diagnosis and treatment methods available to subjects and their potential benefits and risks; (8) When applicable, indicating that subjects may be assigned to different groups in the clinical trial; (9) Subjects Participants participating in clinical trials are voluntary, and have the right to withdraw at any stage of the clinical trial without discrimination or retaliation, and their medical treatment and rights will not be affected; However, the medical device clinical trial institution management department, ethics committee, drug supervision and management department, health and health management department, or inspectors and auditors may consult the personal data of subjects participating in clinical trials according to prescribed procedures when necessary for their work; (10) 1) The free diagnosis and treatment items and other related compensation that the subjects may obtain during the clinical trial; (12) The treatment and/or compensation that the subjects can obtain in the event of injury related to the clinical trial; During the clinical trial, the test subjects can keep abreast of relevant information at any time
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The informed consent form should indicate the version and date of the formulation or the revised version and date
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The informed consent form should be in a language and script that the subjects can understand
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The informed consent form should not contain any content that would cause subjects to give up their legitimate rights and interests and exempt medical device clinical trial institutions, principal investigators, and sponsors from responsibilities
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Article 15 Follow-up review by the ethics committee: (1) The ethics committee shall follow-up and supervise the clinical trial of medical devices, and if the rights and safety of the subjects cannot be guaranteed, it may request in writing to suspend or terminate the clinical trial at any time.
(2) The ethics committee needs to review the safety information such as serious adverse events that occurred in the clinical trial institution reported by the investigator, and review the safety information such as the serious adverse events related to the trial medical device reported by the sponsor
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The ethics committee may request to revise the clinical trial protocol, informed consent and other information provided to the subjects, and suspend or terminate the clinical trial; Possible impact, or possible impact on the scientificity and integrity of medical device clinical trials
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Article 16 During the clinical trial of medical devices, the revision of the clinical trial protocol and the written informed consent and other documents, and the resumption of the suspended clinical trial shall only be implemented after obtaining the written consent of the ethics committee
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Article 17 The ethics committee shall keep all the records of the ethics review, including the written records of the ethics review, member information, submitted documents, meeting minutes and related records of exchanges,
etc.
Chapter III Medical Device Clinical Trial Institutions Article 18 A medical device clinical trial institution shall meet the filing requirements, and establish an organizational structure and management system for clinical trial management
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A medical device clinical trial institution shall have a corresponding clinical trial management department to undertake the management of medical device clinical trials
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Article 19 The management department of medical device clinical trial institutions shall be responsible for filling in, managing and changing the record information of medical device clinical trial institutions in the medical device clinical trial institution recordation management information system, including information on clinical trial majors, principal investigators, etc.
; Submit the summary report of the medical device clinical trial in the previous year online in the filing system; be responsible for organizing the evaluation of the qualifications of the principal investigator of the clinical trial and completing its filing before the ethics committee reviews the medical device clinical trial
.
Article 20 A medical device clinical trial institution shall establish a quality management system, covering the whole process of the implementation of medical device clinical trials, including training and assessment, implementation of clinical trials, management of medical devices, management of biological samples, adverse events and device defects and safety information reporting, recording, quality control and other systems, to ensure that the principal investigators perform their clinical trial-related duties, to ensure that subjects receive proper medical treatment, and to ensure the authenticity of the data generated by the trial
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Article 21 Before accepting clinical trials of medical devices, medical device clinical trial institutions shall evaluate relevant resources according to the characteristics of the experimental medical devices, and ensure that they have matching qualifications, personnel, facilities, and conditions
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Article 22 Medical device clinical trial institutions and investigators shall cooperate with the supervision and inspection organized by the sponsor, as well as the inspections carried out by the drug regulatory department and the health and health management department
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Article 23 Medical device clinical trial institutions shall properly keep clinical trial records and basic documents in accordance with relevant laws and regulations and contracts with sponsors
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Chapter IV Investigator Article 24 The principal investigator in charge of clinical trials of medical devices shall meet the following conditions: (1) The principal investigator of medical device clinical trials has completed the filing; (2) He is familiar with this specification and relevant laws and regulations; ( 3) Possess the professional knowledge and experience required for the use of experimental medical devices, have undergone relevant training in clinical trials, have experience in clinical trials, and are familiar with the medical device clinical trial protocols, investigator manuals and other materials provided by the sponsor; (4) Have the ability Coordinate, control and use the personnel and equipment for the clinical trial of the medical device, and have the ability to deal with adverse events and other related events that occur in the clinical trial of the medical device
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Article 25 The principal investigator shall ensure that clinical trials of medical devices comply with the latest version of the clinical trial protocol approved by the ethics committee; within the agreed time limit, clinical trials of medical devices shall be carried out in accordance with the provisions of this specification and relevant laws and regulations
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Article 26 The principal investigator may, according to the needs of clinical trials of medical devices, authorize researchers who have received relevant training for clinical trials to organize subject recruitment, informed consent, screening and follow-up; test medical devices and control medical devices (such as management and use of biological samples (if applicable); handling of adverse events and device defects; clinical trial data recording and case report form completion,
etc.
Article 27 Investigators participating in clinical trials of medical devices shall: (1) Have the corresponding professional technical qualifications, training experience and relevant experience to undertake clinical trials of medical devices; (2) Participate in clinical trials of medical devices organized by the sponsor Relevant training, and participate in clinical trials of medical devices within the scope authorized by the principal investigator; (3) Familiar with the principles, scope of application or intended use, product performance, operation methods, installation requirements and technical indicators of the experimental medical devices, etc.
(4) Fully understand and abide by the clinical trial protocol, this specification and relevant laws and regulations, as well as the responsibilities related to the clinical trial of medical devices; Approach
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Article 28 Investigators should abide by the ethical guidelines and relevant ethical requirements of the Declaration of Helsinki of the World Medical Congress, and meet the following requirements: (1) The latest version of the informed consent form approved by the ethics committee and other information provided to the subjects should be used.
(2) Before the subjects participate in the clinical trial, they shall explain to the subjects the details of the experimental medical device and the clinical trial, and inform the subjects of the possible benefits and known and foreseeable risks.
After a full and detailed explanation, the subject shall sign the name and date on the informed consent form, and the investigator shall sign the name and date on the informed consent form; (3) The subject is a person without civil capacity or with limited capacity for civil conduct If the subject lacks reading ability, there should be an impartial witness to witness the entire informed consent process and sign and date the informed consent form; Or induce subjects to participate in clinical trials in other improper ways; (5) Ensure that all affected subjects who have not completed the trial process sign the newly revised informed consent form after the informed consent form is updated and the ethics committee review and consent are obtained.
Consent
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Article 29 The investigator is responsible for the management of the trial medical device and the reference medical device (if applicable) provided by the sponsor, and shall ensure that it is only used for the subjects participating in the clinical trial of the medical device, and shall comply with the requirements during the clinical trial.
Storage and custody shall be handled in accordance with relevant laws and regulations and the contract with the sponsor after the clinical trial is completed or terminated
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Article 30 Investigators shall ensure that the collection, processing, preservation, transportation, and destruction of biological samples in clinical trials of medical devices comply with clinical trial protocols and relevant laws and regulations
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Article 31 When an adverse event occurs in a clinical trial of a medical device, the investigator shall provide sufficient and timely treatment and treatment for the subject; when the subject develops a concurrent disease requiring treatment and treatment, the investigator shall promptly inform the subject tester
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Investigators should record adverse events and device defects found during clinical trials of medical devices
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Article 32 Investigators shall report safety information in clinical trials of medical devices in a timely manner: (1) When serious adverse events occur in clinical trials of medical devices, researchers shall immediately take appropriate treatment measures for the subjects; at the same time, The investigator shall report to the sponsor, the management department of the medical device clinical trial institution, and the ethics committee within 24 hours after learning of the serious adverse event; follow up the serious adverse event in accordance with the provisions of the clinical trial protocol, and submit a follow-up report of the serious adverse event; (II) ) When it is found that the risks of a medical device clinical trial exceed the possible benefits, and it is necessary to suspend or terminate the clinical trial, the principal investigator shall report to the sponsor, the management department of the medical device clinical trial institution, and the ethics committee, notify the subjects in a timely manner, and ensure that the recipients are subject to Subjects received appropriate treatment and follow-up
.
Article 33 The principal investigator shall deal with the safety information received in a timely manner: (1) When receiving the serious adverse events and other safety information related to the investigational medical device provided by the sponsor, he shall sign for it in a timely manner, and consider accepting the information.
If necessary, communicate with the subjects as soon as possible; (2) When receiving a notice from the sponsor or the ethics committee that the clinical trial of medical devices needs to be suspended or terminated, the subjects shall be notified in a timely manner, and the subject shall be ensured Subjects received appropriate treatment and follow-up
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Article 34 The principal investigator shall report the progress of clinical trials of medical devices to the ethics committee on time, and promptly report events affecting the rights and safety of subjects or deviations from the clinical trial protocol
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Article 35 Medical device clinical trial institutions and investigators shall report in writing to the drug administration of the province, autonomous region, or municipality directly under the Central Government where the sponsor is located if the sponsor seriously or continuously violates this specification and relevant laws and regulations, or requests changes to the trial data and conclusions.
Management report
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Chapter V Sponsor Article 36 The sponsor shall be responsible for the authenticity and compliance of medical device clinical trials
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If the sponsor is an overseas institution, it shall designate an enterprise legal person within China as an agent in accordance with relevant laws and regulations, and the agent shall assist the sponsor to perform its duties
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Article 37 The quality management system of the sponsor shall cover the whole process of clinical trials of medical devices, including the selection of medical device clinical trial institutions and principal investigators, the design of clinical trial protocols, the implementation, records, and results of medical device clinical trials.
Reporting and filing,
etc.
The sponsor's quality management measures should be commensurate with the risks of the clinical trial
.
Article 38 Before initiating a clinical trial of a medical device, the sponsor shall: (1) Ensure that the product design has been finalized, and complete the preclinical research of the experimental medical device, including performance verification and confirmation, product inspection report based on product technical requirements, risk benefit (2) According to the characteristics of the experimental medical device, select the registered medical device clinical trial institutions, majors and principal investigators; (3) Responsible for organizing the formulation of the investigator’s manual , clinical trial protocols, informed consent forms, case report forms, standard operating procedures and other relevant documents, and provide them to medical device clinical trial institutions and principal investigators
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Article 39 The sponsor shall sign a contract with the medical device clinical trial institution and the principal investigator, specifying the rights and obligations of each party in the medical device clinical trial
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Article 40 The sponsor shall file a clinical trial project with the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the sponsor is located after the medical device clinical trial has passed the ethics review and signed a contract with the medical device clinical trial institution
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After the medical device clinical trial filing is completed, the medical device clinical trial institution can start the informed consent and screening of the first subject
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Article 41 Before the clinical trial of a medical device starts, the sponsor shall be responsible for organizing training related to the clinical trial of the medical device, such as the principle, scope of application, product performance, operation method, installation requirements, technical indicators and clinical trials of the medical device.
Test protocols, standard operating procedures, and other related documents, etc.

.
Article 42 The sponsor shall provide the trial medical device free of charge and meet the following requirements: (1) The trial medical device shall be produced in accordance with the relevant requirements of the Good Manufacturing Practice for Medical Devices and be of qualified quality; (2) Confirm the transportation of the trial medical device conditions, storage conditions, storage time, validity period, etc.
; (3) The experimental medical device shall be properly packaged and stored in accordance with the requirements of the clinical trial protocol; the product information shall be marked on the packaging label, with an easily identifiable and correctly coded mark, indicating that it is only used for (4) After the medical device clinical trial is approved by the ethics committee, the sponsor is responsible for transporting the experimental medical device to the medical device clinical trial institution under specified conditions; For experimental medical devices, the sponsor is responsible for keeping records of recycling and disposal
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Article 43 The sponsor shall pay the fees related to the clinical trial of medical devices for the subjects
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When a subject suffers damage or death related to a medical device clinical trial, the sponsor shall bear the corresponding treatment expenses, compensation or compensation, but does not include the fault of the investigator and the medical device clinical trial institution and the subject's own disease progression.
damage caused
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Article 44 The sponsor shall be responsible for the evaluation and reporting of safety information during the medical device trial: (1) The sponsor shall be informed of the death or life-threatening serious adverse event related to the clinical trial medical device within 7 days, and the notification of non-death or Within 15 days after information on serious adverse events and other serious safety risks related to non-life-threatening experimental medical devices, report to other medical device clinical trial institutions, ethics committees, and principal investigators participating in clinical trials, and report to the province, autonomous region, or province where the sponsor is located.
The municipal drug regulatory department shall report to the drug regulatory department and the health and health management department of the province, autonomous region, or municipality where the medical device clinical trial institution is located, and take risk control measures; When implementing or possibly changing the information agreed by the ethics committee, the clinical trial protocol, the informed consent form and other information provided to the subjects, as well as other relevant documents should be revised in a timely manner, and submitted to the ethics committee for review; In the event of serious adverse events related to medical devices in large-scale clinical trials, or other major safety issues, the sponsor shall suspend or terminate the clinical trials of medical devices, and report to the management departments, ethics committees and principal investigators of all medical device clinical trial institutions.
Report to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the sponsor is located, and report to the drug regulatory department and health management department of the province, autonomous region, or municipality directly under the Central Government where all medical device clinical trial institutions are located
.
Article 45 The sponsor shall assume the responsibility for the supervision of medical device clinical trials, formulate the supervision standard operating procedures, and select the supervisors who meet the requirements to perform the supervision duties: (1) The number of supervisors and the number of supervisors shall be consistent with The complexity of the medical device clinical trial matches the number of medical device clinical trial institutions participating in the clinical trial; (2) Supervisors should have received corresponding training, be familiar with this specification and relevant laws and regulations, have relevant professional background knowledge, and be familiar with experimental medical treatment.
The relevant research materials of the device and the clinical information of similar products, the clinical trial plan and its related documents can effectively perform the supervision duties; The clinical trial of the device is carried out according to the clinical trial plan
.
The content of monitoring includes the compliance of medical device clinical trial institutions and investigators with the clinical trial protocol, this specification and relevant laws and regulations during the implementation of clinical trials; the signing of informed consent of subjects, screening, follow-up, rights and interests and safety assurance management and use of investigational and reference medical devices (if applicable); management and use of biological samples (if applicable); handling of adverse events and device defects; reporting of safety information; clinical trial data records and case report forms Fill in
etc.
Article 46 In order to ensure the quality of clinical trials, sponsors may organize auditors who are independent of medical device clinical trials and have corresponding training and experience to conduct audits on the implementation of clinical trials and evaluate whether the clinical trials conform to the clinical trial protocol and this specification.
and relevant laws and regulations
.
Article 47 The sponsor shall ensure that the implementation of clinical trials of medical devices abides by the clinical trial protocol, and shall promptly point out and make corrections if medical device clinical trial institutions and investigators are found not to comply with the clinical trial protocol, this specification and relevant laws and regulations; If the situation is serious or persists, the clinical trial institution and the investigator shall be terminated from continuing to participate in the clinical trial, and a written report shall be made to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located
.
Article 48 The sponsor shall, within 10 working days after the medical device clinical trial is suspended, terminated or completed, report in writing to all the principal investigators, the management department of the medical device clinical trial institution, and the ethics committee
.
The sponsor shall report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the sponsor is located within 10 working days after the termination or completion of the clinical trial of medical devices
.
Chapter VI Clinical Trial Protocols and Trial Reports Article 49 When conducting clinical trials of medical devices, the sponsor shall, according to the purpose of the trial, comprehensively consider the risks, technical characteristics, scope of application and intended use of the trial medical devices, and organize the formulation of scientific and reasonable clinical trial program
.
Article 50 The clinical trial protocol generally includes the basic information of the product, the basic information of the clinical trial, the purpose of the trial, the risk-benefit analysis, the elements of the trial design, the rationality demonstration of the trial design, statistical considerations, implementation methods (methods, contents, steps), Endpoints of clinical trials, data management, provisions for amendments to clinical trial protocols, provisions for the definition and reporting of adverse events and device defects, and ethical considerations
.
Article 51 The sponsor and the principal investigator shall carry out the clinical trial of medical devices according to the clinical trial plan, and complete the clinical trial report
.
The clinical trial report shall comprehensively, completely and accurately reflect the clinical trial results, and the safety and efficacy data of the clinical trial report shall be consistent with the clinical trial source data
.
Article 52 Clinical trial reports generally include basic information, implementation, statistical analysis methods, test results, reports of adverse events and device defects and their handling, analysis and discussion of test results, clinical trial conclusions, and ethics of medical device clinical trials.
Situation notes, existing problems, and suggestions for improvement
.
Article 53 The clinical trial protocol and clinical trial report shall be signed and dated by the principal investigator, and submitted to the sponsor after being reviewed and signed by the medical device clinical trial institution
.
Chapter VII Multi-center clinical trials Article 54 Multi-center clinical trials refer to clinical trials conducted in two or more (including two) medical device clinical trial institutions according to the same clinical trial plan
.
When a multi-center clinical trial is conducted in different countries or regions, it is a multi-regional clinical trial, and the multi-regional medical device clinical trial conducted within the territory of China shall meet the relevant requirements of this specification
.
Article 55 To conduct a multi-center medical device clinical trial, the sponsor shall meet the following requirements: (1) The sponsor shall ensure that all centers participating in the medical device clinical trial can comply with the clinical trial protocol; (2) The sponsor shall report to each The center offers the same clinical trial protocol
.
After the ethics and scientific nature of the clinical trial protocol has been reviewed and approved by the ethics committee of the team leader, the ethics committees of other medical device clinical trial institutions participating in the clinical trial generally no longer propose revisions to the design of the clinical trial protocol, but have the right to disagree Conduct trials at their medical device clinical trial institutions; (3) Each center shall use the same case report form and fill in the instructions to record the test data obtained in the medical device clinical trial; (4) Before the medical device clinical trial begins, There should be written documents clarifying the responsibilities of the principal investigators of each center participating in the clinical trial of medical devices; (5) The sponsor should ensure communication between the principal investigators of each center; (6) The sponsor is responsible for selecting and determining the clinical trials of medical devices The coordinating investigator, and the medical institution where the coordinating investigator works is the team leader unit
.
The coordinating investigator undertakes the coordination work of each center in the multi-center clinical trial
.
Article 56 The multi-center clinical trial report shall be signed and dated by the coordinating investigator, and submitted to the sponsor after being reviewed and signed by the medical device clinical trial institution of the team leader
.
The clinical trial summary of each sub-center shall be signed and dated by the principal investigator of the center, and submitted to the sponsor after being reviewed and signed by the medical device clinical trial institution of the center
.
Sub-center clinical trial summary mainly includes personnel information, test medical device and control medical device (if applicable) information, trial overview, case enrollment, implementation of clinical trial protocol, summary and descriptive analysis of trial data, medical device clinical Trial quality management, occurrence and handling of adverse events and device defects, and description of protocol deviations,
etc.
Chapter VIII Recording Requirements Article 57 The clinical trial data of medical devices shall be true, accurate, complete and traceable
.
The source data of medical device clinical trials shall be clearly identifiable, and shall not be changed arbitrarily; when it is really necessary to change, the reasons shall be explained, signed and dated
.
Article 58 During clinical trials of medical devices, the principal investigator shall ensure that any observations and discoveries are correctly and completely recorded.

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For clinical trials with patients as subjects, relevant medical records shall be recorded in outpatient or inpatient medical records
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Article 59 The principal investigator shall ensure that the case report form is filled out and revised in accordance with the guidelines provided by the sponsor, and that the data in the case report form is accurate, complete, clear and timely
.
The data reported in the case report form should be consistent with the source document
.
The modification of the data in the case report form should ensure that the initial record is clear and identifiable, the modification track should be kept, and the modification should be signed and dated
.
Article 60 If an electronic data collection system is used in clinical trials of medical devices, the system shall be verified reliably, with complete authority management and audit trail, which can be traced back to the creator of the record, the time of creation or modification, the modification time, In case of modification, the collected electronic data can be traced back to the source
.
Article 61 The basic documents for clinical trials of medical devices are used to evaluate the implementation of the regulations and the relevant requirements of drug regulatory authorities by sponsors, medical device clinical trial institutions and principal investigators
.
The drug supervision and administration department can check the basic documents of medical device clinical trials and use them as the basis for confirming the authenticity of the implementation of medical device clinical trials and the integrity of the collected data
.
Article 62 Sponsors and medical device clinical trial institutions shall have places and conditions for the preservation of basic clinical trial documents, and shall establish a basic document management system
.
The basic documents of clinical trials of medical devices are divided into three parts according to the clinical trial stage: documents of preparation stage, documents of progress stage, and documents after completion or termination
.
Article 63 Sponsors and medical device clinical trial institutions shall ensure the integrity of basic clinical trial documents during the preservation period, and avoid intentional or unintentional alteration or loss.

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(1) The researcher shall properly keep the basic documents of the clinical trial during the clinical trial of medical devices; (2) The medical device clinical trial institution shall keep the basic documents of the clinical trial until 10 years after the completion or termination of the clinical trial of the medical device; (3) Ethics The committee shall keep all the records of the ethical review until 10 years after the completion or termination of the clinical trial of the medical device; (4) The sponsor shall keep the basic documents of the clinical trial until the medical device is not used
.
Chapter IX Supplementary Provisions Article 64 The meaning of the following terms in this specification: Medical device clinical trial refers to the normal use of medical devices (including in vitro diagnostic reagents) to be applied for registration in qualified medical device clinical trial institutions.
The process of confirming safety and efficacy under conditions
.
Medical device clinical trial institutions refer to institutions that meet relevant conditions and conduct clinical trials of medical devices in accordance with this specification and relevant laws and regulations, including blood centers and central blood stations that undertake clinical trials of in vitro diagnostic reagents, and disease prevention at the city level or above with districts Control institutions, drug rehabilitation centers and other non-medical institutions
.
A clinical trial protocol refers to a document describing the purpose, design, methodology, organization and implementation of a medical device clinical trial
.
Clinical trial protocols include protocols and their revisions
.
A clinical trial report is a document describing the design, execution, statistical analysis and results of a medical device clinical trial
.
A case report form refers to a document designed in accordance with the provisions of the medical device clinical trial protocol to record all the information and data of each subject obtained during the trial
.
The Investigator's Manual refers to a compilation of data provided by the sponsor to help the principal investigator and other investigators participating in the clinical trial to better understand and comply with the clinical trial protocol, including but not limited to: the sponsor's basic information, test medical device information Summary description, summary and evaluation of the reasons for supporting the intended use of the experimental medical device and the design of the clinical trial, possible risks, recommended precautions and emergency treatment methods, etc.

.
An experimental medical device refers to a medical device to be applied for registration whose safety and effectiveness are confirmed in the clinical trial of the medical device
.
The reference medical device refers to the medical device that has been marketed in the People's Republic of China as a control in the clinical trial of medical devices
.
Ethics committee refers to an independent committee composed of appropriate personnel, whose responsibility is to ensure that the rights and safety of subjects participating in clinical trials of medical devices are protected
.
Informed consent refers to the process in which subjects confirm their willingness to participate in the clinical trial of medical devices after they are informed of all aspects of the clinical trial of medical devices.
A written signed and dated informed consent form shall be used as a supporting document.

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Subjects refer to individuals who voluntarily participate in clinical trials of medical devices
.
An impartial witness refers to an individual who has nothing to do with the clinical trial of medical devices and is not unjustly affected by the relevant personnel of the clinical trial.
When the subject is incapable of reading, as an impartial witness, read the informed consent and other information provided to the subject.
information and witness informed consent
.
Sponsor refers to the institution or organization that initiates, manages and provides financial support for clinical trials of medical devices
.
Investigators refer to those who conduct clinical trials of medical devices in medical device clinical trial institutions
.
The principal investigator refers to the person in charge of the medical device clinical trial in the medical device clinical trial institution
.
The coordinating investigator refers to the investigator designated by the sponsor to carry out coordination work in a multicenter clinical trial, generally the principal investigator of the team leader unit
.
Supervision means that in order to ensure that the clinical trial of medical devices can comply with the clinical trial protocol, this specification and relevant laws and regulations, the sponsor selects special personnel to conduct evaluation and investigation on medical device clinical trial institutions and researchers, and conducts evaluation and investigation of medical device clinical trials in the process of medical device clinical trials.
Data validation and logging and reporting activities
.
Audit refers to the systematic and independent inspection of activities and documents related to medical device clinical trials organized by the sponsor to determine whether the execution of such activities, data recording, analysis and reporting conform to the clinical trial protocol, this specification and relevant laws.
regulations
.
Inspection refers to the supervision and management activities carried out by the regulatory authorities on the relevant documents, facilities, records and other aspects of medical device clinical trials
.
Deviation refers to the intentional or unintentional failure to comply with the requirements of the medical device clinical trial protocol
.
Adverse events refer to adverse medical events that occur during clinical trials of medical devices, regardless of whether they are related to the experimental medical devices
.
Serious adverse events refer to medical device clinical trials that lead to death or serious deterioration of health status, including fatal diseases or injuries, permanent defects in body structure or function, requiring hospitalization or prolonged hospitalization, and requiring medical treatment.
Measures to avoid permanent defects in body structure or function; events leading to fetal distress, fetal death, or congenital anomalies, congenital defects,
etc.
Device defects refer to the unreasonable risks of medical devices that may endanger human health and life safety under normal use conditions during clinical trials, such as label errors, quality problems, malfunctions,
etc.
Source data refers to the original records of clinical findings, observations and other activities in medical device clinical trials and all information in their approved copies that can be used for medical device clinical trial reconstruction and evaluation
.
Source files refer to printed, visual or electronic files containing source data
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Article 65 The format template of the medical device clinical trial protocol and other documents shall be separately formulated by the State Drug Administration
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Article 66 This specification shall come into force on May 1, 2022
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Interpretation of "Quality Management Practice for Clinical Trials of Medical Devices" 1.
Background of revision Order No.
25) (hereinafter referred to as the "2016 Specification")
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The implementation of this standard has established the guidelines for clinical trials of medical devices, and has played a positive role in strengthening the management of clinical trials of medical devices and safeguarding the rights and interests of subjects
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In recent years, with the deepening of the reform of the medical device review and approval system, a number of reform policies have been introduced, such as the change of medical device clinical trial institutions from qualification accreditation to record management.
development needs
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In order to implement the reform requirements of the review and approval system for medical devices, the newly revised "Regulations on the Supervision and Administration of Medical Devices", "Administrative Measures for Medical Device Registration and Filing", and "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" will be implemented, and the application of international medical device supervision will be actively transformed.
To coordinate the document, it is necessary to revise and supplement the 2016 "Specifications" to meet the needs of the current medical device clinical trial supervision work
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2.
Scope of application Within the territory of the People's Republic of China, the relevant activities of clinical trials of medical devices for the purpose of applying for registration of medical devices (including in vitro diagnostic reagents) shall abide by the "Specifications"
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The "Specifications" cover the whole process of medical device clinical trials, including the design, implementation, supervision, inspection, inspection, data collection, recording, preservation, analysis, summary and reporting of medical device clinical trials
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3.
Main Contents The Specification has nine chapters and 66 articles.
The chapter names are General Provisions, Ethics Committee, Medical Device Clinical Trial Institutions, Investigators, Sponsors, Clinical Trial Protocols and Trial Reports, Multicenter Clinical Trials, Recording Requirements and Supplementary Provisions.

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The chapter of general rules specifies the legal basis and scope of application; the chapter of ethics committee specifies the principles and review requirements of ethical review; the chapter of medical device clinical trial institutions clarifies that medical device clinical trial institutions should have corresponding clinical trial management departments, which are responsible for the management of medical device clinical trials.
work; the investigator chapter emphasizes the conditions and responsibilities that the investigator should have; the sponsor chapter highlights the main responsibility of the sponsor, requiring the sponsor's quality management system to cover the entire process of medical device clinical trials; clinical trial protocols and trial reports The chapter outlines the general requirements, main content, signature requirements, etc.
of the protocol and report; the multi-center clinical trial chapter specifies the definition and requirements of multi-center; the record requirements chapter specifies the basic principles of clinical trial records, and the case report form is filled out, electronically Data collection makes requirements; Supplementary chapters provide terminology and implementation dates
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4.
Key revisions (1) Adjusting the overall framework The chapters of pre-clinical trial preparation, protection of subjects' rights and interests, and management of experimental medical devices in the 2016 Specification are assigned to the responsibilities of each participant in the clinical trial
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This adjustment structure is more clear and emphasizes the responsibilities of all parties.
First, it highlights the main responsibility of the sponsor, introduces the concept of risk management, and clearly stipulates that the sponsor's quality management system should cover the whole process of clinical trials of medical devices; second, it strengthens clinical trials of medical devices.
The testing institution requires that the clinical trial institution shall establish a clinical trial management organizational structure and management system; the third is to emphasize the responsibility of the researcher, and the researcher shall conduct clinical trials of medical devices in accordance with the "Specifications" and relevant laws and regulations
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(2) Incorporating in vitro diagnostic reagents into the "Specifications" management In order to meet the needs of the in vitro diagnostic reagent industry and supervision, this revision incorporates the requirements for the quality management of clinical trials of in vitro diagnostic reagents into the "Specifications", reflecting the unification of clinical trial quality management concepts and requirements sex
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(3) Adjustment of the safety information reporting process The Specification optimizes and adjusts the safety information reporting process
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One is to change "dual report" to "single report"
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The sponsor shall report to the provincial drug regulatory department, the provincial drug regulatory department and the health management department where the medical device clinical trial institution is located.

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The second is to determine the scope of reporting as serious adverse events related to experimental medical devices
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Third, the reporting time limit for death or life-threatening risks is required to be within 7 days after the sponsor is informed, and the reporting time limit for non-death or non-life-threatening and other serious safety risks is within 15 days after the sponsor is informed
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(4) Simplify and optimize the relevant requirements The "Specification" combines the needs of the industry and the actual situation of supervision, and practically solves the problems that are currently reflected more intensively
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The requirement that "clinical trials of medical devices should be conducted in two or more clinical trial institutions for medical devices" is deleted, which solves the problem that it is difficult and unnecessary to conduct clinical trials in two clinical trial institutions for some medical devices
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The one-year validity period of the inspection report has been cancelled, which is conducive to the smooth development of clinical trials
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(5) Reflecting the requirements of the latest international regulatory system, the "Specification" draws on the relevant content of the regulatory coordination documents of the International Medical Device Regulators Forum (IMDRF), such as absorbing the content of IMDRF MDCE WG/N57 FINAL: 2019 "Clinical Trials", which is introduced in different countries or The concept of multi-regional clinical trials carried out in regions is conducive to the simultaneous development of medical device clinical trials in China for global innovative products
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During the revision process, the relevant content of ISO 14155:2020 "Good Practice for Clinical Trials of Medical Devices" and ISO 20916:2019 "In Vitro Diagnostic Medical Devices-Clinical Performance Studies Using Human Samples-Good Research Quality Management Practices" was fully referenced, in the main text The content of the latest edition of the International Standard is reflected in many places
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V.
The "Specification" on the connection between the new and the old system documents will be implemented on May 1, 2022, and the "Specification" in 2016 will be implemented in accordance with the "Decision of the State Administration for Market Regulation on Amending and Abolishing Some Regulations" (Order No.
55 of the State Administration for Market Regulation).
No.
), which will be repealed on May 1, 2022
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From May 1, 2022, clinical trial projects of medical devices that have not passed the ethical review should be adjusted in accordance with the "Specifications" to carry out clinical trials; for projects that have passed the first ethical review, work can be carried out in accordance with the requirements of the original relevant documents
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6.
Supporting documents on the "Specification" In order to cooperate with the implementation of the "Specification" and further guide the development of clinical trials, our bureau has formulated the "Model Clinical Trial Protocol for Medical Devices", "Model Clinical Trial Report for Medical Devices", and "Model Clinical Trial Protocol for In Vitro Diagnostic Reagents".
"Six documents of "In Vitro Diagnostic Reagent Clinical Trial Report Template", "Medical Device/In Vitro Diagnostic Reagent Clinical Trial Serious Adverse Event Report Form Template", and "Medical Device/In Vitro Diagnostic Reagent Clinical Trial Basic Document Catalog" are implemented simultaneously with the "Specifications"
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