Second, the implementation of clinical trials of medical devices and supervision and inspection, shall be in accordance with these provisions.
Article 3 The provisions of the referred to in the clinical trials of medical devices refers to: obtaining the qualification of medical devices clinical trials of medical institutions (hereinafter referred to as medical institutions) to apply for the registration of medical devices in the normal use of the conditions of safety and efficacy in accordance with the provisions of the trial or validation of the process.
The purpose of the clinical trials of medical devices is to evaluate whether the subject product has the expected safety and effectiveness.
Article IV Clinical trials of medical devices shall comply with the ethical principles of the Declaration of Helsinki of the World Medical Assembly (Annex 1), impartiality, respect for human dignity, and strive to maximize the benefit of the subjects and avoid harm as far as possible.
Article V. Clinical trials of medical devices are divided into clinical trials of medical devices and clinical verification of medical devices.
Medical device clinical trial refers to the clinical use to verify the theoretical principles of the medical device, the basic structure, performance and other elements can ensure the safety and effectiveness.
Medical device clinical verification refers to the clinical use to verify that the medical device and the main structure, performance and other elements of the listed products are substantially equivalent, whether the same safety and effectiveness.
The scope of the clinical trial of medical devices: the market has not yet appeared, the safety and effectiveness of medical devices to be confirmed.
The scope of clinical verification of medical devices: similar products have been marketed, the safety and effectiveness of medical devices need to be further confirmed.
Article VI of the prerequisites for clinical trials of medical devices:
(a) the product has a review of the registered product standards or the corresponding national and industry standards;
(b) the product has a self-test report;
(c) the product has the State Council's food and drug supervision and management department in conjunction with the State Council's quality and technical supervision departments recognized testing organizations Type test report issued by the product, and the conclusion is qualified;
(d) the test product for the first time for the implantation of medical devices, should have the product's animal test report;
Other need to confirm the safety of the product by the animal testing of human clinical trials of the product, should also be submitted to the animal test report.
Chapter II Protection of Rights and Interests of Subjects
Article VII Clinical trials of medical devices shall not be charged to the subjects.
Article VIII The person in charge of the clinical trial of medical devices or his/her delegate shall explain the following matters in detail to the subjects or their legal representatives:
(1) The subjects participate in the clinical trial voluntarily and have the right to withdraw from it at any stage of the clinical trial;
(2) The confidentiality of the subjects' personal data. The ethics committee, the (food) drug regulatory authority, and the implementer may access the subject's information, but may not disclose its contents to the public;
(iii) the medical device clinical trial program, in particular, the purpose, process, and duration of the medical device clinical trial, the possible benefits expected from the subject, and the risks that may be incurred;
(iv) during the medical device clinical trial, the medical institution has the (d) during the clinical trial of medical devices, the medical institution has the obligation to provide the subjects with information related to the clinical trial;
(e) due to the trial product causes damage to the subjects, the implementer shall give the subjects the corresponding compensation; the relevant compensation shall be set out in the contract for the clinical trial of medical devices.
Article IX subjects in the full understanding of the content of the clinical trial of medical devices on the basis of the "informed consent". In addition to the provisions of the Informed Consent shall include the items listed in Article 8, shall also include the following:
(a) the signature of the person in charge of the clinical trial of medical devices and the date of the signature;
(b) the signature of the subject or his legal representative and the date of the signature;
(c) the medical institution in the clinical trial of medical devices found to be subject to the clinical effects of the product other than the expected effects, the relevant contents of the Informed Consent Form must be revised and re-confirmed by the signature of the subject or his/her legal representative.
Chapter III Clinical Trial Program for Medical Devices
Article 10 The clinical trial program for medical devices is a document stating the purpose of the trial, risk analysis, overall design, test methods and steps. Medical device clinical trials should be developed before the start of the test program, medical device clinical trials must be conducted in accordance with the test program.
Article XI of the medical device clinical trial program should be to maximize the protection of the rights and interests of the subjects, safety and health as the overriding principle, should be responsible for the clinical trial of medical institutions and implementers in accordance with the prescribed format (Annex 2) *** with the design of the development of the Ethics Committee approved the implementation of; if there is any modification, the Ethics Committee must agree.
Article XII of the market has not yet appeared Class III implanted in the body or borrowed from the theory of Chinese medicine made of medical devices, clinical trial program should be filed with the medical device technical review body.
Article XIII has been on the market of similar medical devices adverse events, or the efficacy of medical devices is not clear, the State Food and Drug Administration may develop a unified clinical trial program provisions.
To carry out clinical trials of such medical devices, implementers, medical institutions and clinical trial personnel shall implement the provisions of the unified clinical trial program.
Article XIV of the clinical trial program for medical devices should be specific to the characteristics of the product under test, to determine the number of cases of clinical trials, duration and clinical evaluation criteria, so that the results of the test are statistically significant.
Medical device clinical trial program should prove the theoretical principles of the subject product, the basic structure, performance and other elements of the basic situation as well as the safety and effectiveness of the subject product.
Medical device clinical validation program should prove that the main structure, performance and other elements of the test product and the marketed products are substantially equivalent, whether the same safety, effectiveness.
Article 15 The clinical trial program for medical devices shall include the following:
(1) the title of the clinical trial;
(2) the purpose, background and content of the clinical trial;
(3) the clinical evaluation criteria;
(4) an analysis of the risks and benefits of the clinical trial;
(5) the name of the clinical trial personnel (vi) overall design, including analysis of the possibility of success or failure;
(vii) duration of the clinical trial and the rationale for its determination;
(viii) number of cases of the clinical trial for each disease and the rationale for its determination;
(ix) scope of the selection of the subject, the number of subjects, and the rationale for the selection, and the setup of the control group, if necessary;
(j) therapeutic products should have a clear indication or scope of application;
(k) clinical performance evaluation methods and statistical treatment;
(l) side effect prediction and measures that should be taken;
(m) the subjects of the "Informed Consent";
(xiv) the responsibilities of all parties.
Article 16 The medical institution and the implementer sign the clinical trial program agreed by both parties, and sign a clinical trial contract.
Article XVII clinical trials of medical devices shall be conducted in more than two (including two) medical institutions.
Chapter IV Medical Device Clinical Trial Implementers
Article 18 The implementer is responsible for initiating, implementing, organizing, funding and monitoring the clinical trial. Implementers for the application for registration of the medical device product units.
Article 19 Responsibilities of the Implementer:
(1) Select medical institutions in accordance with law;
(2) Provide the medical institutions with the "Instructions for Clinical Trials of Medical Devices";
(3) Design and formulate the clinical trial program of the medical device with the medical institution***, and sign the mutually agreed upon clinical trial program of the medical device and contract;
(4) Provide the subjected clinical trial with the medical institution free of charge;
() (D) to the medical institutions free of charge to provide the products under test;
(E) the training of medical device clinical trial personnel;
(F) to the medical institutions to provide a guarantee;
(G) the occurrence of serious side effects should be truthful and timely, respectively, to the acceptance of the application for the registration of the medical device to the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments and the State Food and Drug Administration report, and at the same time to the conduct of the medical devices, the State Food and Drug Administration to report to the medical institutions. Drug Administration to report, and at the same time to other medical institutions conducting clinical trials of the medical device notification;
(viii) the implementer to discontinue the clinical trial of the medical device, shall notify the medical institution, the Ethics Committee and the acceptance of the application for registration of the medical device provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department and the State Food and Drug Administration, and the reasons for this;
(IX) subject to product damage to the subject, the implementer shall give the subject compensation in accordance with the contract for clinical trials of medical devices.Article 20 of the "Instructions for Clinical Trials of Medical Devices" shall include the following:
(1) the principle of the product under test, indications, functions, expected to achieve the purpose of use, the use of the requirements of the instructions, installation requirements of the instructions;
(2) the technical specifications of the product under test;
(3) the State Council Food and Drug Administration, in conjunction with the State Council Quality and Technical Supervision Department of the State Council in conjunction with the recognized testing organizations issued by the type test report of the subject product;
(d) the risks that may arise from the recommended preventive and emergency treatment methods;
(e) confidentiality issues that may be involved.
Chapter V Medical Institutions and Clinical Trials of Medical Devices
Article 21 The medical institutions undertaking clinical trials of medical devices refer to the clinical trial bases of medicines recognized by the Food and Drug Administration under the State Council in conjunction with the health administrative department of the State Council.
Article 22 The medical device clinical trial personnel shall have the following conditions:
(1) have the professional expertise, qualifications and ability to undertake the clinical trial;
(2) be familiar with the implementer of the information and literature related to the clinical trial.
Article 23 Responsible for clinical trials of medical devices and clinical trial of medical institutions and clinical trial staff responsibilities:
(1) should be familiar with the relevant information provided by the implementer, and familiar with the use of the product under test;
(2) and the implementer *** with the design and development of clinical trial program, the two sides to sign the clinical trial program and the contract;
(3) truthfully explain the test product to the Subjects to explain the details of the product under test, before the implementation of clinical trials, the subjects must be given sufficient time to consider whether to participate in clinical trials;
(d) truthfully record the side effects and adverse events of the product under test, and analyze the causes; adverse events and serious side effects, should be truthful and timely, respectively, to the acceptance of the application for registration of the medical device to the provinces, autonomous regions, municipalities directly under the Central Government (food) drug Supervision and management department and the State Food and Drug Administration report; the occurrence of serious side effects, should be reported within twenty-four hours;
(e) in the occurrence of side effects, the clinical trial staff should make timely clinical judgment, take measures to protect the interests of the subjects; if necessary, the Ethics Committee has the right to immediately suspend the clinical trial;
(f) the suspension of the clinical trial, should be (F) the clinical trial suspension, should be notified to the subjects, the implementer, the Ethics Committee and the acceptance of the application for registration of medical devices in the provinces, autonomous regions and municipalities directly under the Central (food) Drug Administration and the State Food and Drug Administration, and explain the reasons;
(VII) put forward the clinical trial report, and is responsible for the correctness and reliability of the report;
(VIII) the confidentiality of information provided by the implementer is liable for the obligation of confidentiality.
Article 24 of the medical institutions responsible for clinical trials of medical devices shall determine the host clinical trials of professional and technical personnel 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 Medical Device Clinical Trial Report
Article 25 After the completion of the clinical trial of medical devices, the medical institution responsible for the clinical trial shall be in accordance with the requirements of the medical device clinical trial program and the prescribed format (Annex 3) issued a clinical trial report. Medical device clinical trial report should be signed and dated by the clinical trial personnel, and by the clinical trial of the medical institution to undertake clinical trials in the clinical trial management department to sign the opinion, date and seal.
Article 26 The report of clinical trials of medical devices shall include the following:
(1) the type of disease tested, the total number of cases and the gender, age and grouping analysis of cases, and the setup of the control group (if necessary);
(2) the methodology of the clinical trial;
(3) the statistical methodology and evaluation methodology adopted;
(4) Clinical evaluation criteria;
(v) Clinical trial results;
(vi) Clinical trial conclusions;
(vii) Adverse events and side effects found in the clinical trial and their treatment;
(viii) Analysis of clinical trial effects;
(ix) Indications, scope of application, contraindications and precautions;
(x) Existing problems and suggestions for improvement. ) Problems and suggestions for improvement.
Article 27 The clinical trial of medical devices shall be properly preserved and managed. Medical institutions shall save the clinical trial data until five years after the termination of the trial. Implementers should save clinical trial information to the final production of products put into use ten years later.
Chapter VII Supplementary Provisions
Article 28 The State Food and Drug Administration is responsible for the interpretation of these provisions.
Article 29 The provisions of this April 1, 2004 shall come into force.
Annexes:
1. Declaration of Helsinki of the World Medical Assembly
2. Clinical Trial Programs for Medical Devices
3. Clinical Trial Reports for Medical Devices
Annex 1:
Declaration of Helsinki of the World Medical Assembly
Ethical Guidelines for Medical Research on Human Subjects
Adopted by the 18th World Medical Assembly. , Helsinki, Finland, June 1964
Revised: 29th World Medical Assembly, Tokyo, Japan, October 1975
35th World Medical Assembly, Venice, Italy, October 1983
41st World Medical Assembly, Hong Kong, September 1989
48th World Medical Assembly SomersetWest, South Africa, October 1996
52nd World Medical Congress, Edinburgh, Scotland, October 2000
I. PREFACE
1. The Declaration of Helsinki, drafted by the World Medical Congress, is a statement of ethical norms for human subjects medical research to guide physicians and other participants in human subjects medical research. The Declaration of Helsinki is a statement of ethical guidelines to guide physicians and other participants in human medical research. Human medical research includes the study of the human body itself and related data or information.
2. The promotion and protection of human health is the duty of physicians. It is the knowledge and ethics of the physician that are designed to fulfill this duty.
3. The Geneva Declaration of the World Medical Assembly binds physicians in the language that "the health of the patient must be our first concern". The International Code of Medical Ethics declares that "medical measures that may adversely affect the physical and psychological well-being of the patient should be provided only when it is in the patient's interest to do so."
4.
4. Advances in medicine are based on research that ultimately depends, to some extent, on experimentation with human subjects.
5. In human medical research, consideration of the health of the subject should take precedence over scientific and social interest.
6. The main purpose of medical research on human subjects is to improve methods of prevention, diagnosis and treatment, and to increase the understanding of the etiology and pathogenesis of disease. Even the best proven preventive, diagnostic and therapeutic methods should be continuously tested for their effectiveness, efficiency, feasibility and quality through research.
7. Most preventive, diagnostic, and therapeutic treatments carry risks and burdens in current medical practice and medical research.
8. Medical research should be conducted in accordance with ethical standards that respect and protect the health and rights of all people. Some subject populations are vulnerable and require special protection. The special needs of the economically and medically disadvantaged must be recognized. Particular attention should be paid to subjects who are unable to give or refuse informed consent, subjects who may be coerced into giving informed consent, subjects who do not personally benefit from the research, and subjects who are receiving concurrent therapy.
9. Investigators must be aware of the ethical, legal, and regulatory requirements for human subjects research in their country of residence and meet international requirements. No national ethics, laws and regulations will be allowed to diminish or eliminate the protections afforded to subjects in this Declaration.
II. Basic Principles of Medical Research
10. In medical research, it is the duty of physicians to protect the life and health of subjects and to preserve their privacy and dignity.
11. Human medical research must follow generally accepted scientific principles and be based on a thorough understanding of the scientific literature and relevant information, as well as 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 laboratory animals used in research.
13. The design and conduct of each human trial should be clearly stated in the trial protocol, which should be submitted to an Ethics Approval Committee for review, comment, guidance and, where appropriate, approval. This ethics committee must be independent of the investigator and sponsor and free from any other influence. The ethics committee should comply with the laws and systems of the country in which the trial is conducted. The committee is authorized to monitor the ongoing trial. It is the responsibility of the investigator to submit monitoring information to the committee, especially information on all serious adverse events. The investigator shall also submit other information to the committee for approval, including information on funding, sponsors, institutions, and other potential conflicts of interest or incentives for subjects.
14. The research protocol must include a statement of ethical considerations and demonstrate that the protocol is consistent with the principles stated in this Declaration.
15. Medical research on human subjects should only be carried out by professionally qualified personnel and under the guidance and supervision of clinical medical specialists. The medically qualified person must always be responsible for the subject and never the subject himself or herself, even if he or she has given informed consent to participate in the research.
16. Every human medical study should begin with a careful evaluation of the expected risks, burdens, and benefit ratios for the subject or other persons. This does not preclude healthy subjects from participating in medical research. All study designs should be publicly available.
17. Physicians should conduct human research only when they are confident that the risks of the trial can be adequately anticipated and well managed. The physician should stop the study if the risks are found to outweigh the possible benefits or if positive conclusions and favorable results have been reached.
18. Human medical research should be conducted only when the importance of the purpose of the experiment outweighs the risks and burdens to the subjects themselves. This is especially important when the subjects are healthy volunteers.
19. Medical research should only be conducted when the subject population can benefit from the results of the research.
20. Subjects must volunteer and have a good understanding of the research project.
21. The right of subjects to protect themselves must always be respected. Wherever possible, measures will be taken to respect the privacy of the subject, the confidentiality of patient information, and to minimize the physical and mental impact on the subject and his or her personality.
22. In any human subjects research, each candidate shall be fully informed of the purpose, methodology, source of funding, possible conflicts of interest, the investigator's affiliation with the research organization, the anticipated benefits and potential risks of the research, and possible discomforts. Subjects should be informed of their right to refuse to participate in the trial or to withdraw from the trial at any time and without retaliation. After confirming that the subject understands this 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. In obtaining informed consent for a research project, special attention should be paid to whether the subject has a dependent relationship with the physician or may be coerced to agree to participate. In such cases, informed consent should be obtained from a physician who is fully aware of the research and who is not participating in the study and with whom the subject has no dependence whatsoever.
24. In the case of research subjects who are legally ineligible, physically or mentally incapable of giving informed consent, or who are minors, the investigator must obtain informed consent from their legal representative in accordance with applicable law. These persons may be included in the study only if the study is necessary to promote the health of the group they represent or cannot be conducted in a legally eligible population.
25. When an ineligible subject, such as a minor child, is in fact able to make the decision to participate in the research, the researcher must obtain his or her own consent, in addition to that of a legally authorized representative.
26. Some research cannot obtain consent from subjects, including principal or prior consent, and should be conducted only when the physical/mental condition of the subject does not allow informed consent to be a necessary characteristic of the population. The particular reasons that prevent subjects participating in the study from giving informed consent should be articulated in the trial protocol and submitted to the ethics committee for review and approval. The protocol should also state that informed consent should be obtained as soon as possible from the subjects themselves or from a legally authorized representative for the continuation of the study.
27. Both authors and publishers have ethical responsibilities. When publishing the results of a study, it is the responsibility of the investigator to ensure the accuracy of the results. As with positive results, negative results should be published or otherwise made public. Sources of funding, research affiliations, and any possible conflicts of interest should be stated in publications. Research that is inconsistent with the principles published in this Declaration cannot be accepted for publication.
III. Additional Principles for Integrating Medical Research with Medical Treatment
28. Physicians may combine medical research with medical treatment only if the research has been shown to have potential preventive, diagnostic and therapeutic value. When medical research is combined with medical measures, the patient is protected as a subject of the research by additional regulations.
29. The benefits, risks, burdens and effectiveness of new approaches should be compared with the best available preventive, diagnostic and therapeutic methods. This does not preclude the use of placebo or no treatment as a control in studies where no effective prevention, diagnosis and treatment currently exists.
30 At the end of the study, each enrolled patient should be assured of the most effective prophylactic, diagnostic, and therapeutic methods confirmed by the study.
31. Physicians should fully inform patients of the part of their treatment that is relevant to the study. A patient's refusal to participate in research should in no way affect the patient's relationship with the physician.
32. In the treatment of patients, in the absence of proven prophylactic, diagnostic and therapeutic methods, or in cases where their use has been ineffective, an unproven or new prophylactic, diagnostic and therapeutic method which, in the judgment of the physician, has the potential to save lives, restore health and alleviate suffering should be applied without restriction, subject to the informed consent of the patient. Where possible, these methods should be subject to research and systematic evaluation of their safety and efficacy. New information obtained from all relevant cases should be recorded and published when appropriate. Other relevant principles of this declaration should also be followed.