QUALITY MANAGEMENT REGULATIONS FOR MEDICAL DEVICE CLINICAL TRIALS
On March 23, 2016, the CFDA has released its Quality Management Regulations for Medical Device Clinical Trials (CFDA Decree 2016 No, 25). The Regulations will come into effect on June 1, 2016. 1. The formulation background of the Regulations In 2004, the former SFDA released the Provisions for Medical Device Clinical Trials. However, […]
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