On March 23th, 2016, Good clinical practice for medical devices is issued by CFDA and National Health and Family Planning Commission and will be implemented from June 1st, 2016, to replace current regulations on clinical trials of medical devices in force since 2014. This practice covers the whole process of clinical trials, including plan design, implementation, audition, review and the collection, recording, analysis, summarizing and reporting of data. This practice explicates the precautions in the activities of clinical trials in the form of standard specification to control the quality of medical devices from the beginning.

Valid data from clinical trials is one of the important ways to evaluate the safety of clinical trials. Based on the practical situation of China, referring to relevant international standards and advanced foreign management experience, and for the purpose of protecting the rights of subjects, the practice mainly stresses the following aspects to regulate the behavior of clinical trials and guarantee authentic, reliable, accurate, scientific and integrated results:

1. Define the duties of sponsors, test facilities, researchers and supervising departments of clinical trials, and stress the management responsibilities of sponsors to clinical trials and refine the responsibilities and duties of clinical trial facilities and researchers.

2. Reinforce the protection of the rights of subjects and optimize relevant regulatory regimes and requirements; highlight the role of ethical commission and the informed consent of subjects; explicate the requirements for sponsors to cover any therapeutic fee and relevant financial compensation for injuries or deaths of subjects caused in relation to the trials.

3. Regulate the risk management to clinical trials; stress the risk control through the whole process; explicate the suspending and termination system for clinical trials; specify the duties of sponsors as the main body and guarantee the safety and controllability of clinical trials process.