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 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.