Medical device registrant system pilot work forum was held in Shanghai

On April 19, the pilot work symposium of the medical device registrant system was held in Shanghai. The meeting summarized and analyzed the pilot implementation of the medical device registrant system, and studied and deployed the pilot work in the next stage. Xu Jinghe, deputy Director of the State Drug Administration, attended the meeting.

At the meeting, the drug regulatory departments of Shanghai, Guangdong and Tianjin respectively exchanged views on the preliminary pilot work; Relevant experts introduced the holder system of drug marketing authorization in China; The participants conducted in-depth discussions on key issues such as the essence of the medical device registrant system, how to further release the dividend of the registrant system, how to implement the main responsibility of the quality management of the medical device registrant throughout the life cycle, and how to further improve the regulatory working mechanism.

In October 2017, the State Office of the Central Government issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceutical Medical Devices (Office Word [2017] No. 42), clearly proposing to promote the full implementation of the listing authorization holder system. The implementation of document 42 requirements, in accordance with the deployment of the State Drug Administration, Shanghai, Guangdong, Tianjin three places have carried out the pilot work of the medical device registrant system. At present, the pilot work is being carried out in an orderly manner, and initial results have been achieved.

The meeting pointed out that the implementation of the medical device registrant system is an important measure to seriously implement the new development concept, implement the innovation-driven development strategy, and encourage medical device innovation. Judging from the pilot work in the three places, the medical device registrant system is conducive to encouraging product innovation, optimizing resource allocation, implementing the main responsibility, promoting management innovation, and promoting the high-quality development of the medical device industry. In order to further accumulate experience, the State Food and Drug Administration will further expand the scope of the medical device registrant system pilot.

A total of more than 50 persons in charge of the relevant departments and bureaus of the State Food and Drug Administration and directly affiliated units of the State Food and Drug Administration of 19 provinces (municipalities) and relevant experts participated in the meeting.