Source: sfda.gov.cn

02-24-2009 17:47

The Provisions for Clinical Trials of Medical Devices were passed by the State Food and Drug Administration at the administration affairs meeting on December 22 of 2003, are hereby promulgated and shall go into effect as of April 1,2004.

Zheng Xiaoyu

Commissioner of State Food and Drug Administration

January 17, 2004

 

Provisions for Clinical Trials of Medical Devices

Chapter I General Provisions

Article 1 The provisions are formulated to strengthen the administration of clinical trials of medical devices and to ensure the rights and benefits of testing subjects protected and assuring the truthfulness and reliability of the trials result is based on the Regulations for the Supervision and Administration of Medical Devices.

Article 2 The implementation of, supervision over, and examination into clinical trials of medical devices shall be conducted in accordance with the provisions.

Article 3 Clinical trial under the provisions refers to the process in which the medical institutions qualified for conducting clinical trial of medical devices (medical institutions, for short hereunder) testing and verifying the safety and effectiveness of the medical device submitted to register in normal condition.

The purpose of clinical trials of medical devices is to evaluate the intended safety and effectiveness of the testing products.

Article 4 Clinical trials of medical devices should be conducted in accordance with the ethical principles contained in World Medical Association Declaration of Helsinki (see Appendix 1), respecting human dignity, striving for maximal benefit for the testing subject, and avoiding harm as best one may.

Article 5 The clinical trials of medical devices are divided into clinical testing and clinical verification.

Clinical testing refers to verifying if such factors as the theoretical principle, basic structure and performance of the concerned medical devices are able to guarantee their operating safety and effectiveness, by means of clinical application.

Clinical verification refers to verifying the testing products and the products already in the market are virtually the same in terms of the basic structure, performance, safety and effectiveness.

Scope of clinical testing: those medical devices that have not yet been available in the market, or whose safety and effectiveness are subject to verification.

Scope of clinical verification: those medical devices whose identical products of similar kinds have already been launched onto the market, or whose safety and effectiveness need to be further verified.

Article 6 Medical devices entering clinical trials must possess the following conditions:

(1) The concerned product has measured up to the registered product standard or corresponding state or industrial standard undergoing re-examination.

(2) The concerned product is accompanied by a self-examination report.

(3) The concerned product possess qualified testing report from the testing center recognized by SFDA or State National Quality Standard Supervision department.

(4) If the product to be tested is some medical device that is implanted into human body for the first time, it is necessary to present the animal experiment report for the product.

For other products whose safety to human body in the clinical trials has to be verified by means of animal experiment, it is required to render an animal testing report, too.