Good Clinical Practice for Medical Device Trials
Good Clinical Practice for Medical Device Trials
Good Clinical Practice for Medical Device Trials
Order of the China Food and Drug Administration and the National Health and Family Planning Commission of the People's Republic of China No.25
March 1, 2016
The Good Clinical Practice for Medical Device Trials adopted upon deliberation at an executive meeting of the China Food and Drug Administration and a director meeting of the National Health and Family Planning Commission is hereby promulgated with effect as of June 1, 2016.
Bi Jingquan, Minister of the China Food and Drug Administration
Li Bin, Director of the National Health and Family Planning Commission
Good Clinical Practice for Medical Device Trials
Chapter I General Provisions
Article 1 This Good Clinical Practice for Medical Device Trials (hereinafter referred to as the "GCP") is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices in order to strengthen the administration of medical device clinical trials, protect the rights and interests of subjects participating in medical device clinical trials, and ensure standard medical device clinical trials and authentic, scientific, reliable and traceable results.
Article 2 Medical device clinical trials within the territory of the People's Republic of China shall be governed by this GCP.
This GCP applies to the overall process of a medical device clinical trial from protocol design, implementation, monitoring, auditing and inspection to data collection, recording, analysis and final reporting.
Article 3 For the purpose of this GCP, a medical device clinical trial (hereinafter referred to as a "device trial") refers to the process designed to verify or test the safety and effectiveness of a medical device proposed to be registered under normal working conditions in an eligible device trial institution.
Article 4 Device trials shall be carried out in a lawful, ethical and scientific manner.
Article 5 Food and drug administrations at the provincial level or above shall be responsible for the supervision and administration of device trials.
Competent health and family planning departments shall, to the extent permitted by their duties, strengthen the administration of device trials.
Food and drug administrations and competent health and family planning departments shall establish an information notification mechanism for the administration of device trials, in order to strengthen the information notification on the approval of clinical trials regarding Class III medical devices and the medical devices listed in the National Large Medical Device Catalog for Configuration and Management, as well as the corresponding supervision and administration data about clinical trials.
Chapter II Preparations before Clinical Trials
Article 6 Device trials shall have sufficient scientific basis and specific objectives, and consider both expected benefits and risks to the health of subjects and the public. The expected benefits shall outweigh any potential harm.
Article 7 Before launching a device trial, the sponsor shall conduct a preclinical study on the test device, including product design (structure, working principle and functional mechanism, intended use and scope of application, and applicable technical specification), quality inspection, animal testing, and risk analysis, and the results shall be positive to the clinical trial. Quality inspection results shall include a self-inspection report and a registration inspection report valid within one year and issued by an eligible inspection institution.
Article 8 Before launching a device trial, the sponsor shall prepare a sufficient number of test devices. The development of the test device shall meet the relevant requirements of the applicable quality management system for medical devices.
Article 9 A device trial shall be conducted in two or more device trial institutions.
The device trial institutions selected shall have the required qualifications, and have the facilities and conditions qualified for safe and effective clinical trials. Investigators shall have the expertise, qualifications and capabilities to undertake the clinical trial, and shall get the relevant training.
The Administrative Measures for Qualification Certification of Device Trial Institutions are formulated separately by the China Food and Drug Administration in concert with the National Health and Family Planning Commission.
Article 10 Before launching a device trial, the sponsor shall reach a written agreement with clinical trial institutions and investigators on the design, quality control, assignment of responsibilities, and fees to be assumed by the sponsor regarding the trial, as well as the principles for handling possible harm in the trial.
Article 11 Device trials are subject to approval from the ethics committees of clinical trial institutions. For the medical devices listed in the Class III medical device catalog subject to approval for clinical trials, approval from the China Food and Drug Administration shall be obtained.
Article 12 Before launching a device trial, the sponsor shall file with the food and drug administration of the province, autonomous region, or municipality directly under the Central Government where the sponsor is located.
The food and drug administration accepting the filing shall report the filing to the food and drug administration and competent health and family planning department at the same level in the place where the clinical trial institution is located.
Chapter III Safeguarding of Subjects' Rights and Interests
Article 13 Device trials shall comply with the ethical principles set in the World Medical Association Declaration of Helsinki.
Article 14 Ethical review and informed consent are major measures to safeguard the rights and interests of subjects.
The parties participating in a clinical trial shall assume the ethical obligations corresponding to their respective duties in the trial.
Article 15 The sponsor shall avoid improper influence or misleading on the participants such as subjects, clinical trial institutions and investigators, and relevant parties of the clinical trial.
Clinical trial institutions and investigators shall avoid improper influence or misleading on the participants such as subjects and sponsor, and relevant parties of the clinical trial.
Article 16 The sponsor, clinical trial institutions and investigators shall not induce subjects to participate in clinical trials by exaggerating the compensation for the participation.
Article 17 Before launching a device trial, the sponsor shall, through investigators and the clinical trial institution's device trial management department, submit the following documents to the ethics committee:
1. the protocol;
2. the investigator's brochure;
3. the informed consent form and any other written materials for subjects;
4. the procedural documents for subject recruitment and advertisement;
5. the case report form;
6. the self-inspection report and registration inspection report;
7. the resume of investigators and other documents showing their expertise, capabilities, training experience and other qualifications;
8. a summary stating that clinical trial institutions have the facilities and conditions qualified for trials;
9. a statement stating that the development of the test device meets the relevant requirements of the applicable quality management system for medical devices; and
10. other documents required for ethical review.
The ethics committee shall review and supervise the implementation of clinical trials under the ethical and scientific principles.
Article 18 The investigator shall, in a timely manner, report any of the following matters in a clinical trial to the clinical trial institution's device trial management department, through which reporting to the sponsor and the ethics committee in a timely manner:
1. serious adverse events;
2. the progress report, including a summary of safety and deviations;
3. any revision to the documents approved by the ethics committee. No prior reporting is required for the revisions that have no impact on the rights and interests, safety and health of subjects or the nonmaterial revisions irrelevant to the objectives or endpoint of the clinical trial, provided that notification shall be made in writing afterwards.
4. suspension or termination of the clinical trial or request for resuming the suspended clinical trial; and
5. any deviation from the protocol that has an impact on the rights and interests, safety and health of subjects or the scientific nature of the clinical trial, including requested deviation and reported deviation.
To protect the rights and interests, safety and health of subjects, any deviation under emergencies where timely reporting is unavailable shall be reported in writing as soon as possible afterwards in accordance with the relevant provisions.
Article 19 In the process of a clinical trial, a written approval from the ethics committee shall be obtained prior to a revision to the protocol, informed consent form or other documents, a requested deviation, or the resumption of the suspended clinical trial.
Article 20 To the extent possible, subjects shall not be selected from legally incompetent minors, pregnant women, old people, mentally incapacitated people or patients in critical condition. If necessary, additional requirements by the ethics committee shall be complied with, and a protocol shall be designed specially for such subjects based on their physical conditions, and be beneficial to their health.
Article 21 Before subjects participate in a clinical trial, investigators shall provide the subjects or guardians of persons without or with limited capacity for civil conduct with extensive details about the clinical trial, including known and foreseeable risks and possible adverse events. After full and detailed explanation, the subjects or their guardians and investigators shall sign the informed consent forms with their names and dates.
Article 22 Generally, an informed consent form shall include the following content and the information about relevant matters:
1. names of and related information about investigators;
2. names of clinical trial institutions;
3. name, objectives, method and details of the trial;
4. process and duration of the trial;
5. source of funds and possible conflicts of interests;
6. possible benefits, known and foreseeable risks, and possible adverse events for subjects;
7. alternative treatments, potential benefits and risks for subjects;
8. if required, the groups to which subjects may be assigned;
9.
......
Order of the China Food and Drug Administration and the National Health and Family Planning Commission of the People's Republic of China No.25
March 1, 2016
The Good Clinical Practice for Medical Device Trials adopted upon deliberation at an executive meeting of the China Food and Drug Administration and a director meeting of the National Health and Family Planning Commission is hereby promulgated with effect as of June 1, 2016.
Bi Jingquan, Minister of the China Food and Drug Administration
Li Bin, Director of the National Health and Family Planning Commission
Good Clinical Practice for Medical Device Trials
Chapter I General Provisions
Article 1 This Good Clinical Practice for Medical Device Trials (hereinafter referred to as the "GCP") is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices in order to strengthen the administration of medical device clinical trials, protect the rights and interests of subjects participating in medical device clinical trials, and ensure standard medical device clinical trials and authentic, scientific, reliable and traceable results.
Article 2 Medical device clinical trials within the territory of the People's Republic of China shall be governed by this GCP.
This GCP applies to the overall process of a medical device clinical trial from protocol design, implementation, monitoring, auditing and inspection to data collection, recording, analysis and final reporting.
Article 3 For the purpose of this GCP, a medical device clinical trial (hereinafter referred to as a "device trial") refers to the process designed to verify or test the safety and effectiveness of a medical device proposed to be registered under normal working conditions in an eligible device trial institution.
Article 4 Device trials shall be carried out in a lawful, ethical and scientific manner.
Article 5 Food and drug administrations at the provincial level or above shall be responsible for the supervision and administration of device trials.
Competent health and family planning departments shall, to the extent permitted by their duties, strengthen the administration of device trials.
Food and drug administrations and competent health and family planning departments shall establish an information notification mechanism for the administration of device trials, in order to strengthen the information notification on the approval of clinical trials regarding Class III medical devices and the medical devices listed in the National Large Medical Device Catalog for Configuration and Management, as well as the corresponding supervision and administration data about clinical trials.
Chapter II Preparations before Clinical Trials
Article 6 Device trials shall have sufficient scientific basis and specific objectives, and consider both expected benefits and risks to the health of subjects and the public. The expected benefits shall outweigh any potential harm.
Article 7 Before launching a device trial, the sponsor shall conduct a preclinical study on the test device, including product design (structure, working principle and functional mechanism, intended use and scope of application, and applicable technical specification), quality inspection, animal testing, and risk analysis, and the results shall be positive to the clinical trial. Quality inspection results shall include a self-inspection report and a registration inspection report valid within one year and issued by an eligible inspection institution.
Article 8 Before launching a device trial, the sponsor shall prepare a sufficient number of test devices. The development of the test device shall meet the relevant requirements of the applicable quality management system for medical devices.
Article 9 A device trial shall be conducted in two or more device trial institutions.
The device trial institutions selected shall have the required qualifications, and have the facilities and conditions qualified for safe and effective clinical trials. Investigators shall have the expertise, qualifications and capabilities to undertake the clinical trial, and shall get the relevant training.
The Administrative Measures for Qualification Certification of Device Trial Institutions are formulated separately by the China Food and Drug Administration in concert with the National Health and Family Planning Commission.
Article 10 Before launching a device trial, the sponsor shall reach a written agreement with clinical trial institutions and investigators on the design, quality control, assignment of responsibilities, and fees to be assumed by the sponsor regarding the trial, as well as the principles for handling possible harm in the trial.
Article 11 Device trials are subject to approval from the ethics committees of clinical trial institutions. For the medical devices listed in the Class III medical device catalog subject to approval for clinical trials, approval from the China Food and Drug Administration shall be obtained.
Article 12 Before launching a device trial, the sponsor shall file with the food and drug administration of the province, autonomous region, or municipality directly under the Central Government where the sponsor is located.
The food and drug administration accepting the filing shall report the filing to the food and drug administration and competent health and family planning department at the same level in the place where the clinical trial institution is located.
Chapter III Safeguarding of Subjects' Rights and Interests
Article 13 Device trials shall comply with the ethical principles set in the World Medical Association Declaration of Helsinki.
Article 14 Ethical review and informed consent are major measures to safeguard the rights and interests of subjects.
The parties participating in a clinical trial shall assume the ethical obligations corresponding to their respective duties in the trial.
Article 15 The sponsor shall avoid improper influence or misleading on the participants such as subjects, clinical trial institutions and investigators, and relevant parties of the clinical trial.
Clinical trial institutions and investigators shall avoid improper influence or misleading on the participants such as subjects and sponsor, and relevant parties of the clinical trial.
Article 16 The sponsor, clinical trial institutions and investigators shall not induce subjects to participate in clinical trials by exaggerating the compensation for the participation.
Article 17 Before launching a device trial, the sponsor shall, through investigators and the clinical trial institution's device trial management department, submit the following documents to the ethics committee:
1. the protocol;
2. the investigator's brochure;
3. the informed consent form and any other written materials for subjects;
4. the procedural documents for subject recruitment and advertisement;
5. the case report form;
6. the self-inspection report and registration inspection report;
7. the resume of investigators and other documents showing their expertise, capabilities, training experience and other qualifications;
8. a summary stating that clinical trial institutions have the facilities and conditions qualified for trials;
9. a statement stating that the development of the test device meets the relevant requirements of the applicable quality management system for medical devices; and
10. other documents required for ethical review.
The ethics committee shall review and supervise the implementation of clinical trials under the ethical and scientific principles.
Article 18 The investigator shall, in a timely manner, report any of the following matters in a clinical trial to the clinical trial institution's device trial management department, through which reporting to the sponsor and the ethics committee in a timely manner:
1. serious adverse events;
2. the progress report, including a summary of safety and deviations;
3. any revision to the documents approved by the ethics committee. No prior reporting is required for the revisions that have no impact on the rights and interests, safety and health of subjects or the nonmaterial revisions irrelevant to the objectives or endpoint of the clinical trial, provided that notification shall be made in writing afterwards.
4. suspension or termination of the clinical trial or request for resuming the suspended clinical trial; and
5. any deviation from the protocol that has an impact on the rights and interests, safety and health of subjects or the scientific nature of the clinical trial, including requested deviation and reported deviation.
To protect the rights and interests, safety and health of subjects, any deviation under emergencies where timely reporting is unavailable shall be reported in writing as soon as possible afterwards in accordance with the relevant provisions.
Article 19 In the process of a clinical trial, a written approval from the ethics committee shall be obtained prior to a revision to the protocol, informed consent form or other documents, a requested deviation, or the resumption of the suspended clinical trial.
Article 20 To the extent possible, subjects shall not be selected from legally incompetent minors, pregnant women, old people, mentally incapacitated people or patients in critical condition. If necessary, additional requirements by the ethics committee shall be complied with, and a protocol shall be designed specially for such subjects based on their physical conditions, and be beneficial to their health.
Article 21 Before subjects participate in a clinical trial, investigators shall provide the subjects or guardians of persons without or with limited capacity for civil conduct with extensive details about the clinical trial, including known and foreseeable risks and possible adverse events. After full and detailed explanation, the subjects or their guardians and investigators shall sign the informed consent forms with their names and dates.
Article 22 Generally, an informed consent form shall include the following content and the information about relevant matters:
1. names of and related information about investigators;
2. names of clinical trial institutions;
3. name, objectives, method and details of the trial;
4. process and duration of the trial;
5. source of funds and possible conflicts of interests;
6. possible benefits, known and foreseeable risks, and possible adverse events for subjects;
7. alternative treatments, potential benefits and risks for subjects;
8. if required, the groups to which subjects may be assigned;
9.
......