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 food and drug administration, together with the national health and Family Planning Commission, formulated and promulgated the code for the quality management of clinical trials of medical devices (hereinafter referred to as the code), It will come into force on June 1st, 2016.

For the first time, the regulation stipulates that the drug administration departments at or above the provincial level are responsible for the supervision and management of clinical trials of medical devices, and carry out verification against serious or repeated deviation of clinical trial schemes, suspected fraud, etc. Industry insiders pointed out that the introduction of the regulation indicates that after the storm of data verification of drug clinical trials, the field of medical devices will also usher in the storm of clinical data verification this year.