Increase in supervision and management of clinical trials for medical device in China


China Food and Drug Administration (CFDA) and National Health and Family Planning Commission of China (NHFPC) have jointly issued the Good Clinical Practice for medical devices (CFDA Order No. 2) in order to further strengthen the supervision and management of clinical trials of medical devices. The Good Clinical Practice for medical devices has been implemented since June 1, 2016. It comprises of 96 articles in 11 chapters, including general provisions, preparation before clinical trials, protection of rights and benefits of trial subjects, clinical trials protocol, responsibilities of ethics committee, responsibilities of sponsors, responsibilities of clinical trial institutions and investigators, record and report, management of investigational medical devices, management of essential documents, and supplementary provisions.


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