The Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices (Decree of the State Council, No. 680, “the Decision”) has been published and implemented on May 4, 2017. It is hereby announced in terms of implementing the Decision that:

According to the Decision, the clinical trial facilities of medical devices shall be subject to recordation management rather than qualification accreditation. The CFDA is accelerating the formulation of condition and recordation management methods for medical device clinical trial facilities together with the National Health and Family Planning Commission (NHFPC). Before the release of relevant management methods, the sponsors should choose the facilities for drug clinical trials identified by the CFDA and the NHFPC for medical device clinical trials. For in vitro diagnostic reagent clinical trials, it shall be subject to the Circular of the CFDA on Implementing Measures for the Administration of Medical Device Registration and Administrative Measures for the Registration of In vitro Diagnostic Reagent (SYJXG [2014] No. 144).

China Food and Drug Administration

June 20, 2017