Article 1 In order to strengthen the management of clinical trials of medical devices, safeguard the rights and interests of subjects, and ensure the authenticity and reliability of clinical trial results, these regulations are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices".
Article 2 The implementation, supervision and inspection of clinical trials of medical devices shall be in accordance with these regulations.
Article 3 The term “medical device clinical trials” as mentioned in these regulations refers to: the safety of medical devices applying for registration under normal use conditions by medical institutions (hereinafter referred to as medical institutions) that have obtained medical device clinical trial qualifications. and the process of trial or verification of effectiveness in accordance with regulations.
The purpose of medical device clinical trials is to evaluate whether the tested product has the expected safety and effectiveness.
Article 4 Medical device clinical trials should abide by the ethical principles of the World Medical Assembly Declaration of Helsinki (Annex 1), be fair, respect personality, strive to maximize the benefits to subjects and avoid harm as much as possible.
Article 5 Medical device clinical trials are divided into medical device clinical trials and medical device clinical verification.
Clinical trials of medical devices refer to clinical use to verify whether the theoretical principles, basic structure, performance and other elements of the medical device can ensure safety and effectiveness.
Clinical verification of medical devices refers to verifying through clinical use whether the main structure, performance and other elements of the medical device are substantially equivalent to those of marketed products, and whether they have the same safety and effectiveness.
Scope of clinical trials of medical devices: medical devices that have not yet appeared on the market and whose safety and effectiveness have yet to be confirmed.
Scope of clinical verification of medical devices: medical devices whose similar products have been put on the market and whose safety and effectiveness need to be further confirmed.
Article 6 Prerequisites for clinical trials of medical devices:
(1) The product has registered product standards or corresponding national and industry standards that have been reviewed and approved;
(2) The product has a self-test report;
(3) The product has a product type test report issued by a testing agency recognized by the Food and Drug Administration Department of the State Council in conjunction with the Quality and Technical Supervision Department of the State Council, and the conclusion To be qualified;
(4) The product under test is a medical device used for implantation into the human body for the first time, and it should have an animal test report for the product;
Other products need to be confirmed by animal testing For products whose safety is tested in human clinical trials, animal test reports should also be submitted.
Chapter 2 Protection of the Rights and Interests of Subjects
Article 7 No fees may be charged to subjects for clinical trials of medical devices.
Article 8 The person in charge of clinical trials of medical devices or his or her client shall explain the following matters in detail to the subjects or their legal representatives:
(1) Subjects voluntarily participate Clinical trials, the right to withdraw at any stage of the clinical trial;
(2) The personal information of the subjects shall be kept confidential. Ethics committees, (food) and drug regulatory authorities, and implementers may access the subject's information, but may not disclose its contents to the outside world;
(3) Medical device clinical trial plans, especially medical device clinical trials The purpose, process and period, the expected possible benefits of the subjects and the possible risks;
(4) During the clinical trial of the medical device, the medical institution is obliged to provide the subjects with information related to the clinical trial. Information materials;
(5) If the subject is harmed due to the product being tested, the implementer shall provide corresponding compensation to the subject; relevant compensation matters shall be stated in the medical device clinical trial contract.
Article 9 Subjects shall obtain an "Informed Consent" on the basis of fully understanding the contents of the clinical trial of the medical device.
In addition to the items listed in Article 8 of these Regulations, the "Informed Consent Form" should also include the following content:
(1) Signature and date of signature of the person in charge of the clinical trial of the medical device;
(2) The signature and date of signature of the subject or his legal representative;
(3) If a medical institution discovers unexpected clinical effects of the tested product during clinical trials of medical devices, it must report The relevant content of the "Informed Consent Form" will be modified and re-signed and confirmed by the subject or his legal representative.
Chapter 3 Medical Device Clinical Trial Plan
Article 10 The medical device clinical trial plan is a document that clarifies the purpose of the trial, risk analysis, overall design, trial methods and procedures, etc. A test plan should be developed before the clinical trial of a medical device begins, and clinical trials of medical devices must be conducted in accordance with the test plan.
Article 11 The medical device clinical trial plan shall be based on the primary principle of maximizing the protection of the rights, safety and health of the subjects, and shall be prepared by the medical institution and implementer responsible for the clinical trial in the prescribed format ( Attachment 2) ***The design is formulated and implemented after approval by the Ethics Committee; any modifications must be approved by the Ethics Committee.
Article 12 For third-category medical devices that have not yet appeared on the market and are implanted in the body or made using the theory of traditional Chinese medicine, the clinical trial plan shall be filed with the medical device technical review agency.
Article 13 If adverse events occur with similar medical devices that have been marketed, or medical devices with unclear efficacy, the State Food and Drug Administration may formulate unified clinical trial program regulations.
To conduct clinical trials of such medical devices, implementers, medical institutions and clinical trial personnel should implement the provisions of a unified clinical trial plan.
Article 14 The medical device clinical trial plan should determine the number of clinical trial cases, duration and clinical evaluation standards based on the characteristics of the specific product being tested, so that the test results have statistical significance.
The medical device clinical trial plan should prove the basic information of the theoretical principles, basic structure, performance and other elements of the tested product, as well as the safety and effectiveness of the tested product.
The medical device clinical verification plan should prove whether the main structure, performance and other elements of the test product and the marketed product are substantially equivalent, and whether they have the same safety and effectiveness.
Article 15 The medical device clinical trial plan shall include the following contents:
(1) The title of the clinical trial;
(2) The purpose of the clinical trial , background and content;
(3) Clinical evaluation standards;
(4) Risk and benefit analysis of clinical trials;
(5) Clinical trial personnel Name, position, title and department;
(6) Overall design, including analysis of the possibility of success or failure;
(7) Duration of the clinical trial and the reasons for its determination;
(8) The number of clinical trial cases for each disease and the reasons for their determination;
(9) Select the scope of subjects, the number of subjects and the reasons for the selection, and the setting of a control group if necessary;
(10) Therapeutic products should have clear indications or scope of application;
(11) Evaluation methods and statistical processing methods for clinical performance;
(12) Prediction of side effects and measures that should be taken;
(13) "Informed Consent Form" for subjects;
(14) Responsibilities of all parties.
Article 16 The medical institution and the implementer sign a mutually agreed clinical trial plan and sign a clinical trial contract.
Article 17 Clinical trials of medical devices shall be conducted in two or more (including two) medical institutions.
Chapter 4 Medical Device Clinical Trial Implementers
Article 18 The implementer is responsible for initiating, implementing, organizing, funding and monitoring clinical trials. The implementer is the unit that applies for registration of the medical device product.
Responsibilities of the implementer of Article 19:
(1) Select medical institutions in accordance with the law;
(2) Provide medical institutions with the "Instructions for Clinical Trials of Medical Devices" 》;
(3) Design and formulate a medical device clinical trial plan with the medical institution ***, and sign a medical device clinical trial plan and contract agreed by both parties;
(4) Provide free trial products to medical institutions;
(5) Provide training to medical device clinical trial personnel;
(6) Provide guarantees to medical institutions;
(7) The occurrence of serious side effects should be reported truthfully and promptly to the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government that accepted the application for registration of the medical device and the State Food and Drug Administration, and at the same time to the person conducting clinical trials of the medical device. Notification by other medical institutions;
(8) Before suspending the clinical trial of a medical device, the implementer shall notify the medical institution, ethics committee and the province, autonomous region, and municipality (food) drug administration that accepted the registration application for the medical device. department and the State Food and Drug Administration, and explain the reasons;
(9) If the product under test causes damage to the subjects, the implementer shall compensate the subjects according to the medical device clinical trial contract.
Article 20 "Instructions for Clinical Trials of Medical Devices" shall include the following contents:
(1) Principle description, indications, functions, expected purpose of use of the product under test, Description of usage requirements and installation requirements;
(2) Technical indicators of the product under test;
(3) Testing approved by the Food and Drug Administration Department of the State Council in conjunction with the Quality and Technical Supervision Department of the State Council Type test report of the tested product issued by the institution;
(4) Possible risks, recommended prevention and emergency handling methods;
(5) Possible confidentiality issues involved.
Chapter 5 Medical Institutions and Medical Device Clinical Trial Personnel
Article 21 Medical institutions undertaking clinical trials of medical devices refer to medical institutions that have been approved by the Food and Drug Administration of the State Council in conjunction with the State Council. Drug clinical trial base recognized by the health administration department.
Article 22 Medical device clinical trial personnel shall meet the following conditions:
(1) Have the professional expertise, qualifications and abilities to undertake the clinical trial;
(2) Be familiar with the information and literature related to clinical trials provided by the implementer.
Article 23 Responsibilities of medical institutions and clinical trial personnel responsible for clinical trials of medical devices:
(1) Should be familiar with relevant information provided by the implementer and familiar with the product being tested Use of Explain the details of the product being tested. Before the clinical trial is implemented, subjects must be given sufficient time to consider whether to participate in the clinical trial;
(4) Truthfully record the side effects and adverse events of the product being tested, and analyze them Reasons; if adverse events or serious side effects occur, they should be reported truthfully and promptly to the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government that accepted the medical device registration application and the State Food and Drug Administration; if serious side effects occur, they should be reported in Report within 24 hours;
(5) When side effects occur, clinical trial personnel should make prompt clinical judgments and take measures to protect the interests of subjects; if necessary, the ethics committee has the right to immediately suspend Clinical trials;
(6) If clinical trials are suspended, the subjects, implementers, ethics committees, and the (food) drug regulatory authorities of the provinces, autonomous regions, and municipalities that accepted the application for registration of the medical device shall be notified. State Food and Drug Administration, and explain the reasons;
(7) Submit a clinical trial report and be responsible for the accuracy and reliability of the report;
(8) Responsible for the implementer The information provided is subject to confidentiality obligations.
Article 24: Medical institutions responsible for clinical trials of medical devices shall identify professional and technical personnel who will preside over clinical trials as the person in charge of clinical trials. The person in charge of clinical trials should have a professional title of attending physician or above.
Chapter 6 Medical Device Clinical Trial Report
Article 25 After the completion of the medical device clinical trial, the medical institution undertaking the clinical trial shall comply with the requirements of the medical device clinical trial plan and Issue a clinical trial report in the prescribed format (Annex 3). The medical device clinical trial report shall be signed and dated by the clinical trial personnel, and shall be signed, dated, and stamped by the clinical trial management department of the medical institution undertaking the clinical trial.
Article 26 Medical device clinical trial reports shall include the following contents:
(1) Types of diseases tested, total number of cases, gender, age, group analysis of cases, and comparison Setting of groups (if necessary);
(2) Clinical trial methods;
(3) Statistical methods and evaluation methods used;
(4) ) Clinical evaluation standards;
(5) Clinical trial results;
(6) Clinical trial conclusions;
(7) Adverse events discovered in clinical trials and side effects and their treatment;
(8) Clinical trial effect analysis;
(9) Indications, scope of application, contraindications and precautions;
(10) Existing problems and suggestions for improvement.
Article 27 Medical device clinical trial data should be properly preserved and managed. Medical institutions should retain clinical trial data for five years after the trial is terminated. The implementer shall retain clinical trial data until ten years after the last produced product is put into use.
Chapter 7 Supplementary Provisions
Article 28 The State Food and Drug Administration is responsible for the interpretation of these regulations.
Article 29 These regulations will come into effect on April 1, 2004.
Attachments: 1. World Medical Assembly Declaration of Helsinki
2. Medical device clinical trial plan
3. Medical Device Clinical Trial Report
Annex 1:
World Medical Assembly Declaration of Helsinki
Ethical Guidelines for Medical Research on Human Subjects
Adopted: No. 18th World Medical Congress, Helsinki, Finland, June 1964
Revised: 29th World Medical Congress, Tokyo, Japan, October 1975
35th World Medical Congress Congress, Venice, Italy, October 1983
41st World Medical Congress, Hong Kong, September 1989
48th World Medical Congress, Somerset West, South Africa, 1996 October
The 52nd World Medical Congress, Edinburgh, Scotland, October 2000
1. Foreword
1. The Declaration of Helsinki drafted by the World Medical Congress is a statement of ethical principles for medical research on human subjects to guide doctors and other participants in medical research on human subjects. Human medical research includes research on the human body itself and related data or information.
2. It is the duty of physicians to promote and protect human health. It is this duty that the doctor's knowledge and ethics are designed to fulfill.
3. The World Medical Assembly's Declaration of Geneva binds physicians with language such as "the health of the patient must be our first consideration." International standards of medical ethics declare: “Doctors may provide medical measures that may have adverse effects on the patient’s physiology and psychology only if they are in the patient’s interests.”
4. Advances in medicine are based on research, which ultimately relies, in part, on experiments using human subjects.
5. In human medical research, considerations for the health of subjects should take precedence over scientific and social interests.
6. The main purpose of human medical research is to improve prevention, diagnosis and treatment methods and to increase understanding of the etiology and pathogenesis of diseases.
Even the best proven prevention, diagnosis and treatment methods should continue to be tested through research for their effectiveness, efficiency, feasibility and quality.
7. In current medical practice and medical research, most prevention, diagnosis, and treatment involve risks and burdens.
8. Medical research should comply with ethical standards, respect all people, and protect their health and rights. Some subject groups are vulnerable groups and require special protection. The special needs of the economically and medically disadvantaged must be recognized. Special attention should be paid to those subjects who are unable to give informed consent or refuse to give informed consent, subjects who may have given informed consent under duress, subjects who will not personally benefit from the research, and subjects who are concurrently receiving treatment. tester.
9. Researchers must be aware of the ethical, legal and regulatory requirements for human subjects research in their host country and must comply with international requirements. The ethics, laws and regulations of any country do not allow the reduction or elimination of the protection of subjects provided for in this declaration.
2. Basic principles of medical research
10. In medical research, it is the doctor's responsibility to protect the life and health of subjects and maintain their privacy and dignity.
11. Human medical research must comply with generally accepted scientific principles and be based on a comprehensive understanding of the scientific literature and relevant information and adequate laboratory and animal testing (if necessary).
12. Research that may affect the environment must be conducted with due care and respect for the rights of experimental animals used in research.
13. The design and conduct of each human trial should be clearly stated in the trial protocol, and the trial protocol should be submitted to the ethics approval committee for review, comment, guidance, and, where appropriate, review and approval. The ethics committee must be independent of the investigator and sponsor and not influenced by any other party. The ethics committee should comply with the laws and systems of the country where the trial is conducted. The committee has the power to oversee ongoing trials. Researchers have the responsibility to submit monitoring data to the committee, especially data on all serious adverse events. Investigators should also submit additional information to the committee for review and approval, including information regarding funding, sponsors, research institutions, and other potential conflicts of interest or incentives for subjects.
14. Research protocols must describe ethical considerations and demonstrate that the protocol is consistent with the principles stated in this declaration.
15. Medical research on human subjects can only be conducted by professionally qualified personnel and under the guidance and supervision of clinical medical experts. It is always a medically qualified person who is responsible for the subject, and never the subject himself, even if the subject has given informed consent to participate in the study.
16. Before every human medical research begins, the expected risks, burdens, and benefits to subjects or other persons should be carefully evaluated. This does not exclude healthy subjects from participating in medical research. All study designs should be publicly available.
17. Doctors can only conduct human research when they are confident that the risks involved in the trial can be fully anticipated and managed appropriately. Physicians should stop a study if the risks are found to outweigh the possible benefits or if positive conclusions and favorable results have been reached.
18. Medical research on human subjects can only be conducted when the purpose of the trial outweighs the risks and burdens on the subjects themselves. This is particularly important when the subjects are healthy volunteers.
19. Medical research can only be conducted if the subject population will benefit from the results of the research.
20. Subjects must participate voluntarily and have full knowledge of the research project.
21. The rights of subjects to protect themselves must always be respected. Measures shall be taken whenever possible to respect the subject's privacy, the confidentiality of patient information and to minimize the impact on the subject's physical and mental well-being.
22. In any human research study, each candidate subject should be fully informed of the purpose, methods, funding sources, possible conflicts of interest, the investigator's research affiliations, the anticipated benefits and potential risks of the study, and Possible discomfort.
Subjects should be informed of their right to refuse participation in the trial or to withdraw from the trial at any time without retaliation. After confirming that the subject understands the information, the physician should obtain the subject's voluntary informed consent, preferably in writing. If written consent cannot be obtained, the process of obtaining unwritten consent must be formally documented and witnessed.
23. When obtaining informed consent for a research project, special attention should be paid to whether the subject has a dependent relationship with the doctor or may be forced to agree to participate. In this case, informed consent should be obtained by a physician who is fully informed but not participating in the study and has no relationship with the subject.
24. For research subjects who are legally ineligible, whose physical or mental condition does not allow them to give informed consent, or who are minors, researchers must comply with relevant laws and obtain informed consent from their legally authorized representatives. These individuals may be included in research only if the research is necessary to promote the health of the group they represent or cannot be conducted in a legally eligible population.
25. When subjects without legal qualifications, such as underage children, can actually make the decision to participate in research, the researcher must obtain the consent of the subject in addition to the consent of the legally authorized representative.
26. Some research cannot obtain consent from the subject, including principal or prior consent, and the research can only be conducted if the subject's physical/mental condition does not allow for informed consent, a necessary characteristic of this population. The special reasons that prevent subjects participating in the study from giving informed consent should be stated in the trial protocol and submitted to the ethics committee for review and approval. The protocol also needs to state that informed consent should be obtained as soon as possible from the subject himself or his legally authorized representative for continued research.
27. Both authors and publishers share ethical responsibilities. When publishing research results, researchers are responsible for ensuring the accuracy of the results. Like positive results, negative results should be published or otherwise made public. Funding sources, research affiliations, and any possible conflicts of interest should be stated in the publication. Research reports that are inconsistent with the principles promulgated in this declaration will not be accepted for publication.
3. Additional principles for the integration of medical research and medical care
28. Physicians may combine medical research with medical measures, but only if the research has proven to have potential preventive, diagnostic and therapeutic value. When medical research is combined with medical treatment, additional regulations are required to protect patients as research subjects.
29. The benefits, risks, burdens, and effectiveness of new approaches should be compared with the best available prevention, diagnosis, and treatment methods. This does not preclude the use of placebo or no treatment as controls in studies where no effective methods of prevention, diagnosis or treatment currently exist.
30. At the end of the study, each enrolled patient should be assured of the most effective prevention, diagnosis, and treatment methods proven by the study.
31. Physicians should fully inform patients that part of their treatment is research-related. A patient's refusal to participate in a study should in no way affect that patient's relationship with the physician.
32. In the treatment of patients, if there are no proven prevention, diagnosis and treatment methods, or the use is ineffective, if the doctor determines that an unproven or new prevention, diagnosis and treatment method is expected to save lives, restore health health and relief of suffering, this approach should be applied without restriction, subject to the informed consent of the patient. Where possible, these methods should be the subject of research and their safety and effectiveness should be systematically evaluated. New information obtained from all relevant cases will be recorded and published as appropriate. At the same time, other relevant principles of this declaration must be followed.