NMPA issues the Notice on Expanding the Pilot of the Medical Device Registrant System

As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Review & Approval System to Encourage Innovation in Drugs and Medical Devices (General Office [2017] No. 42), to accelerate the innovation and development of the medical device industry, on the basis of the early pilots of medical device registrant system in Shanghai, Guangdong and Tianjin Free Trade Zones, on August 1, 2019, NMPA issued the Notice on Expanding the Pilot of the Medical Device Registrant System (NMPA Department for Medical Device Registration [2019] No. 33, hereinafter referred to as the Notice, to further expand the pilot program of the medical device registrant system, and further accumulate experience for the full implementation of it. 

The Notice stipulates the corresponding conditions and obligations for the registrants and the entrusted manufacturers participating in the pilot, clarifying that both parties should sign the entrustment contract and quality assurance agreement; it also stipulates the procedures for product registration, alterations and manufacturer license. At the same time, it is emphasized that drug regulatory authorities at all levels should strengthen supervision and management of registrants' performance of obligations such as guaranteeing quality of medical devices, market sales and services, monitoring and evaluation of adverse events of medical devices, and recall of medical devices, etc.