Technical Guideline for Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices
In order to better meet the public's clinical needs for medical devices and promote technological innovation in medical devices, according to the Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (Office  No. 42) issued by General Office of the CPC Central Committee and General Office of the State Council as well as the national requirements for medical device registration management, this Guideline is hereby formulated. This Guideline is intended to provide technical guidance for applicants to apply for registration using data derived from overseas clinical trials of medical devices and for supervision authorities to review such clinical trial data, to avoid or reduce repetitive clinical trials and speed up marketing of medical devices in China.
This Guideline is applicable to guiding the acceptance of data derived from overseas clinical trials of a medical device (including IVD reagent) as the materials for clinical evaluation, when the applicant applies for registering the medical device in China.
II. Basic Principles for Acceptance of Overseas Clinical Trial Data
(1) Ethical Principle
Overseas clinical trials shall abide by the codes of ethics determined by the World Medical Association Declaration of Helsinki. In addition, the applicant shall describe the norms and standards specified by the ethics, laws and regulations of the country (region) where the clinical trial is carried out, or international norms and standards.
(2) Legal Principle
Overseas clinical trials shall be carried out in countries (regions) that implement quality management of clinical trials and meet the Chinese regulatory requirements for the clinical trials of medical devices (including IVD reagents). Any difference existing between the clinical trial quality management documents used in the overseas clinical trials and the Good Clinical Practice for Medical Devices (GCP) shall be explained in detail, and it shall be fully demonstrated that such difference will not affect the authenticity, scientificity, reliability and traceability of the research results and that the rights and interests of the subject are protected. The applicant and clinical trial institutions shall be subject to the supervision and inspection of the China Food and Drug Administration.
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