＂Quality management standard for clinical trials of medical

In order to strengthen the management of clinical trials of medical devices, safeguard the rights and interests of subjects in the process of clinical trials of medical devices, and ensure that the clinical trials of medical devices are standardized and the results are authentic, scientific, reliable and traceable, according to the regulations on the supervision and administration of medical devices, the State Food and Drug Administration and the state health and Family Planning Commission formulated and promulgated the quality of clinical trials of medical devices The specification for quantity management (hereinafter referred to as the code) will be implemented from June 1, 2016.
 
It is the first time that the drug regulatory departments at or above the provincial level shall be responsible for the supervision and management of clinical trials of medical devices, and to carry out verification for serious or repeated clinical trial protocol deviation and suspected fraud. Industry insiders pointed out that the promulgation of the "specification" indicates that after the drug clinical trial data verification storm, the medical device field will also usher in the clinical data verification storm this year.