Article 2 The implementation, supervision and inspection of clinical trials of medical devices shall abide by these provisions.
Article 3 The term "clinical trial of medical devices" as mentioned in these Provisions refers to the process in which a medical institution that has obtained the qualification for clinical trial of medical devices (hereinafter referred to as the medical institution) tests or verifies the safety and effectiveness of the medical devices that apply for registration under normal use conditions according to regulations.
The purpose of clinical trials of medical devices is to evaluate whether the tested products have the expected safety and effectiveness.
Article 4 Clinical trials of medical devices shall abide by the moral principles of the Helsinki Declaration of the World Medical Congress (Annex 1), be fair and respect personality, and strive to maximize the benefits of the subjects and avoid injuries as much as possible.
Article 5 Clinical trials of medical devices are divided into clinical trials of medical devices and clinical verification of medical devices.
Clinical trial of medical devices refers to verifying whether the theoretical principle, basic structure, performance and other factors of medical devices can ensure the safety and effectiveness through clinical use.
Clinical verification of medical devices refers to verifying whether the main structure, performance and other factors of medical devices are substantially equivalent to the listed products, and whether they have the same safety and effectiveness through clinical use.
Clinical trial scope of medical devices: medical devices that have not appeared in the market and whose safety and effectiveness need 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 further confirmation.
Article 6 Prerequisites for clinical trials of medical devices:
(1) The product has passed the examination of registered product standards or corresponding national and industrial standards;
(2) The product has a self-inspection report;
(3) The product has a product type test report issued by the US Food and Drug Administration in the State Council and a testing organization recognized by the the State Council Quality and Technical Supervision Department, and the conclusion is qualified;
(4) The tested product is a medical device implanted into human body for the first time, and there shall be an animal test report of the product;
Other products that need to be confirmed by animal tests in human clinical trials shall also submit animal test reports.
Chapter II Protection of Subject Rights and Interests
Seventh clinical trials of medical devices shall not charge any fees to the subjects.
Article 8 The person in charge of clinical trials of medical devices or their clients shall explain the following matters in detail to the subjects or their legal representatives:
(1) Subjects voluntarily participate in the clinical trial and have the right to withdraw from the clinical trial at any stage;
(2) The personal data of the subjects shall be kept confidential. The Ethics Committee, the (food) drug supervision and administration department and the implementer may consult the information of the subjects, but shall not disclose its contents to the outside world;
(3) the clinical trial plan of medical devices, especially the purpose, process and duration of the clinical trial of medical devices, the expected benefits and possible risks of the subjects;
(4) During the clinical trial of medical devices, medical institutions are obliged to provide the subjects with information related to the clinical trial;
(5) If the inspected product causes damage to the inspected person, the implementer shall compensate the inspected person accordingly; The medical device clinical trial contract shall specify the relevant compensation matters.
Article 9 The subjects obtained informed consent on the basis of fully understanding the contents of clinical trials of medical devices. In addition to the matters listed in Article 8 of these Provisions, the informed consent shall also include the following contents:
(a) the signature of the person in charge of the clinical trial of medical devices and the date of signature;
(2) the signature and date of signature of the subject or its legal representative;
(three) medical institutions in the clinical trial of medical devices found that the tested products have unexpected clinical effects, it is necessary to modify the relevant contents of the informed consent form, and the subject or his legal representative to re-sign and confirm.
Chapter III Clinical Trial Scheme of Medical Devices
Article 10 The clinical trial plan of medical devices is a document that defines the purpose, risk analysis, overall design, test methods and steps of the test. Before the start of clinical trials of medical devices, a trial plan should be made, and clinical trials of medical devices must be carried out in accordance with this test plan.
Article 11 The primary principle of the clinical trial scheme of medical devices is to protect the rights and interests, safety and health of the subjects to the maximum extent, which shall be formulated by the medical institutions and implementers in charge of clinical trials in accordance with the prescribed format (Annex 2) and implemented after being approved by the ethics committee; If there are any changes, it must be approved by the ethics Committee.
Article 12 The clinical trial scheme of Class III medical devices implanted into the body or made by borrowing the theory of traditional Chinese medicine that has not yet been listed shall be filed with the medical device technical evaluation institution.
Article 13 The State Food and Drug Administration of the United States may formulate a unified clinical trial plan for adverse events that have been listed or similar medical devices with unclear curative effects.
To carry out clinical trials of such medical devices, implementers, medical institutions and clinical trial personnel shall implement the provisions of a unified clinical trial plan.
Article 14 The clinical trial scheme of medical devices shall determine the number of clinical trial cases, duration and clinical evaluation criteria according to the characteristics of specific tested products, so as to make the test results statistically significant.
The clinical trial scheme of medical devices shall prove the basic information of the theoretical principle, basic structure, performance and other elements of the tested products and the safety and effectiveness of the tested products.
The clinical verification scheme of medical devices shall prove whether the main structure, performance and other elements of the tested products and the products already on the market are substantially equivalent, and whether they have the same safety and effectiveness.
Article 15 The clinical trial scheme of medical devices shall include the following contents:
(a) the theme of the clinical trial;
(2) The purpose, background and content of the clinical trial;
(3) Clinical evaluation criteria;
(4) Risk and benefit analysis of clinical trials;
(five) the name, position, title and department of the clinical trial personnel;
(six) the overall design, including the possibility analysis of success or failure;
(seven) the duration of the clinical trial and the reasons for its determination;
(eight) the number of clinical trials of each disease and its reasons;
(nine) select the scope of the object, the number of objects and the reasons for the selection, and set up a control group when necessary;
(ten) therapeutic products should have clear indications or scope of application;
(eleven) evaluation methods and statistical processing methods of clinical manifestations;
(twelve) side effects prediction and measures to be taken;
(13) informed consent of the subject;
(14) responsibilities of all parties.
Sixteenth medical institutions and practitioners should sign a clinical trial plan and clinical trial contract agreed by both parties.
Seventeenth clinical trials of medical devices should be conducted in medical institutions above the second level (including the second level).
Chapter IV Practitioners in Clinical Trials of Medical Devices
Eighteenth implementers are responsible for initiating, implementing, organizing, funding and monitoring clinical trials. The implementer is the unit that applies for the registration of medical device products.
Article 19 Responsibilities of implementers:
(1) Choosing medical institutions according to law;
(two) to provide medical institutions with "clinical trial instructions for medical devices";
(3) Designing and formulating clinical trial plans for medical devices together with medical institutions, and signing clinical trial plans and contracts for medical devices agreed by both parties;
(4) Providing testing products to medical institutions free of charge;
(5) Training clinical testers of medical devices;
(6) Providing guarantees to medical institutions;
(7) Serious side effects shall be truthfully and promptly reported to the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and the State Food and Drug Administration of the United States, and other medical institutions conducting clinical trials of the medical device shall be notified at the same time;
(8) Before suspending the clinical trial of medical devices, the implementer shall notify the medical institution, the ethics committee, the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and the State Food and Drug Administration of the United States, and explain the reasons;
(nine) if the tested product causes damage to the subject, the implementer shall compensate the subject according to the clinical trial contract of medical devices.
Twentieth "medical device clinical trial program" shall include the following contents:
(1) A description of the principle, indications, functions, expected uses, use requirements and installation requirements of the tested product;
(two) the technical indicators of the products under inspection;
(three) the type test report issued by the food and drug supervision and administration department of the State Council in conjunction with the testing institution recognized by the quality and technical supervision department of the State Council;
(four) possible risks, recommended prevention and emergency treatment methods;
(5) possible confidentiality issues.
Chapter V Medical Institutions and Clinical Testers of Medical Devices
Twenty-first medical institutions that undertake clinical trials of medical devices refer to drug clinical trial bases recognized by the food and drug supervision and administration department of the State Council in conjunction with the health administrative department of the State Council.
Article 22 Clinical testers of medical devices shall meet the following conditions:
(1) Having the professional knowledge, qualification and ability to undertake clinical trials;
(two) familiar with the information and literature related to clinical trials provided by the implementers.
Article 23 Responsibilities of medical institutions and clinical testers responsible for clinical trials of medical devices:
(a) should be familiar with the relevant information provided by the implementer, and familiar with the use of the product under test;
(2) Design and formulate a clinical trial plan with the implementer, and both parties sign the clinical trial plan and contract;
(three) truthfully explain the details of the tested products to the subjects, and before the implementation of clinical trials, the subjects must be given sufficient time to consider whether to participate in clinical trials;
(four) truthfully record the side effects and adverse events of the tested products, and analyze the reasons; Adverse events and serious side effects shall be reported truthfully and timely to the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and the State Food and Drug Administration of the United States; Serious side effects should be reported within twenty-four hours;
(five) when side effects occur, clinical trial personnel should make clinical judgments in time and take measures to protect the interests of the subjects; When necessary, the ethics committee has the right to immediately suspend clinical trials;
(6) If the clinical trial is suspended, it shall notify the subjects, implementers, ethics committees, food and drug administrations of provinces, autonomous regions and municipalities directly under the Central Government and the State Food and Drug Administration of the United States, and explain the reasons;
(seven) clinical trial report, and be responsible for the correctness and reliability of the report;
(8) The information provided by the implementer shall be kept confidential.
Twenty-fourth medical institutions responsible for clinical trials of medical devices shall determine the professional and technical personnel who preside over clinical trials as the person in charge of clinical trials. The person in charge of clinical trials shall have the title of attending physician or above.
Chapter VI Clinical Trial Report of Medical Devices
Article 25 After the clinical trial of medical devices is completed, the medical institution undertaking the clinical trial shall issue a clinical trial report in accordance with the requirements of the clinical trial plan of medical devices and the prescribed format (Annex 3). The clinical trial report of medical devices shall be signed and dated by the clinical trial personnel, and the clinical trial management department in the medical institution undertaking the clinical trial shall sign the opinions, date and seal.
Article 26 The clinical trial report of medical devices shall include the following contents:
(1) Analysis of experimental diseases, total number of cases, sex, age and grouping of cases, and setting of control group (if necessary);
(2) Clinical trial methods;
(3) The statistical methods and evaluation methods adopted;
(4) Clinical evaluation criteria;
(five) the results of clinical trials;
(6) Clinical trial conclusion;
(seven) adverse events and side effects found in clinical trials and their treatment;
(8) Clinical trial effect analysis;
(nine) indications, scope of application, contraindications and precautions;
(10) Problems and suggestions for improvement.
Twenty-seventh clinical trial data of medical devices should be properly preserved and managed. Medical institutions shall keep the clinical trial data for five years after the termination of the trial. The implementer shall keep the clinical trial data for ten years after the final product is put into use.
Chapter VII Supplementary Provisions
Article 28 The State Food and Drug Administration shall be responsible for the interpretation of these Provisions.
Article 29 These Provisions shall come into force as of April 1 day, 2004.
Attachment: 1 Helsinki Declaration of the World Medical Congress
2. Clinical trial scheme of medical devices
3. Clinical trial report of medical devices
Attachment 1:
Helsinki Declaration of the World Medical Congress
Ethical principles of human medical research
Adopted by: 18 World Medical Congress, Helsinki, Finland,1June 964.
Revision: 29th World Medical Congress, Tokyo, Japan, 1975 65438+ 10.
The 35th World Medical Congress, Venice, Italy, 1983 10.
World Medical Congress, Hong Kong, 1989.
The 48th World Medical Congress, Somerset, South Africa, 10, 1996 65438+ day.
The 52nd World Medical Congress was held in Edinburgh, Scotland, from 5 to 38 June 2000.
I. Introduction
1. The Helsinki Declaration drafted by the World Medical Congress is a statement on the ethical standards of human medical research, which is used to guide doctors and other people involved in human medical research. Human medical research includes the study of the human body itself and related data or materials.
It is the duty of doctors to promote and protect human health. The knowledge and morality of doctors is to fulfill this duty.
3. The Geneva Declaration of the World Medical Congress binds doctors with the language that "the health of patients must be our first consideration". The International Standard of Medical Ethics declares: "Only when it is in the interests of patients can doctors provide medical measures that may have adverse effects on patients' physiology and psychology".
The progress of medicine is based on research, and research ultimately depends on experiments with human subjects to some extent.
5. In human medical research, the consideration of subjects' health should take precedence over the interests of science and society.
6. The main purpose of human medical research is to improve the methods of prevention, diagnosis and treatment, and to improve the understanding of the etiology and pathogenesis of diseases. Even the best prevention, diagnosis and treatment methods that have been proved should be constantly tested for their effectiveness, efficiency, feasibility and quality through research.
7. In current medical practice and research, most prevention, diagnosis and treatment involve risks and burdens.
8. Medical research should follow ethical standards, respect all people and protect their health and rights. Some subjects are vulnerable groups and need special protection. We must recognize the special needs of people who are economically and medically disadvantaged. Special attention should be paid to those subjects who can't give informed consent or refuse to give informed consent, subjects who may give informed consent under coercion, subjects who can't benefit from the research and subjects who are receiving treatment at the same time.
9. Researchers must understand the ethical, legal and regulatory requirements of the host country for human research and meet international requirements. The ethics, laws and regulations of any country are not allowed to reduce or cancel the protection provided for subjects in this declaration.
Second, the basic principles of medical research
10. In medical research, the doctor's duty is to protect the life and health of the subjects and safeguard their privacy and dignity.
1 1. Human medical research must follow generally accepted scientific principles and be based on a comprehensive understanding of scientific literature and related materials and adequate laboratory and animal experiments (if necessary).
12. Research that may affect the environment must be conducted with caution, and the rights of experimental animals used for research should be respected.
13. The design and implementation of each human trial should be clearly stated in the trial plan, which should be submitted to the ethics review and approval committee for review, comment, guidance and review and approval when appropriate. The ethics committee must be independent of the researchers and organizers and not influenced by any other aspects. The ethics committee shall abide by the laws and regulations of the country where the experiment is conducted. The Committee has the right to supervise the ongoing experiment. It is the responsibility of researchers to submit monitoring data to the Committee, especially all serious adverse events data. Researchers should also submit other information for approval by the Committee, including information about funds, applicants, research institutions and other potential conflicts of interest or encouraging subjects.
14. The research plan must have an ethical explanation and show that the plan conforms to the principles stated in this statement.
15. Human medical research can only be conducted by qualified personnel under the guidance and supervision of clinical medical experts. The person in charge of the subject must always be a medically qualified person, but it is by no means the subject himself, even if the subject knowingly agrees to participate in the study.
16. Before each human medical research begins, the expected risk, burden and benefit ratio of the subjects or other personnel should be carefully evaluated. This does not exclude healthy subjects from participating in medical research. All research designs should be made public.
17. Doctors can only conduct this human research if they are sure that they can fully foresee the risks in the experiment and handle them well. If it is found that the risk exceeds the possible benefit or positive conclusions and favorable results are obtained, the doctor should stop the research.
18. Only when the importance of the experimental purpose exceeds the risk and burden of the subjects themselves can human medical research be carried out. This is especially important when the subjects are healthy volunteers.
19. Only when the subjects can benefit from the research results can medical research be carried out.
20. Subjects must participate voluntarily and have a full understanding of the research project.
2 1. The subjects' right to protect themselves must always be respected. Take measures as far as possible to respect the privacy of the subjects, keep the patient's information confidential, and minimize the impact on the subjects' body, spirit and personality.
22. In any human research, each candidate should be fully informed of the research purpose, methods, sources of funds, possible conflicts of interest, research subsidiary where the researcher belongs, expected benefits and potential risks of the research, and possible discomfort. The subjects should be informed that they have the right to refuse to participate in the experiment or withdraw from the experiment at any time without any retaliation. When confirming that the subject knows this information, the doctor should obtain the informed consent voluntarily given by the subject, preferably in writing. If written consent cannot be obtained, the process of obtaining non-written consent must be formally recorded and witnessed.
23. When obtaining the informed consent of the research project, special attention should be paid to whether the subjects and doctors are dependent or may be forced to agree to participate. In this case, the informed consent form should be obtained by a doctor who fully understands but does not participate in this study and is independent of the co-subjects.
24. For research subjects or minors who do not have legal qualifications and are not allowed to give informed consent due to their physical or mental conditions, researchers must obtain informed consent from their legal plenipotentiaries according to relevant laws. Only when the research is necessary to promote the health of the group they represent, or if it cannot be carried out among people with legal qualifications, can these people be included in the research.
25. When unqualified subjects, such as underage children, can actually make a decision to participate in the research, the researcher must obtain the consent of himself in addition to the consent of the legally authorized representative.
26. Some studies can't get the consent of the subjects, including the client's or previous consent. Only when the physical/mental condition of the subject does not allow informed consent is a necessary feature of this population can the study be carried out. The special reasons why subjects can't give informed consent should be made clear in the experimental scheme and submitted to the ethics Committee for examination and approval. The plan also needs to explain that the informed consent of the subject himself or his legally authorized agent should be obtained as soon as possible in continuing the study.
27. Both authors and publishers should bear moral responsibility. When publishing research results, researchers have the responsibility to ensure the accuracy of the results. Like positive results, negative results should be published or made public in other ways. The sources of funds, research affiliates and any possible conflicts of interest should be stated in the publication. Research reports that do not conform to the principles declared in this declaration cannot be accepted and published.
Third, the additional principle of combining medical research with medical treatment.
Doctors can combine medical research with medical measures, but only if the research has been proved to have potential preventive, diagnostic and therapeutic value. When medical research is combined with medical measures, patients as research objects should be protected by additional laws and regulations.
29. The benefits, risks, burdens and effectiveness of new methods should be compared with the best existing prevention, diagnosis and treatment methods. This does not rule out the use of placebo or no treatment as a control in studies with no effective prevention, diagnosis and treatment methods at present.
30. At the end of the study, each selected patient should ensure that the most effective prevention, diagnosis and treatment methods confirmed by the study can be obtained.
3 1. Doctors should fully inform patients which part of their treatment is related to the research. The patient's refusal to participate in the study should not affect the relationship between the patient and the doctor.
32. In the treatment of patients, if there is no proven prevention, diagnosis and treatment method, or the use is ineffective, if doctors judge that an unconfirmed or new prevention, diagnosis and treatment method is expected to save lives, restore health and alleviate pain, they should apply this method without restriction with the informed consent of patients. If possible, these methods should be taken as research objects and their safety and effectiveness should be evaluated in a planned way. Record the new information obtained from all relevant cases and publish it in due course. At the same time, we should follow other relevant principles of this declaration.