Notice Of NMPA On Expanding The Pilot Work Of The Medical Device Registrant System


Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, Shaanxi Province (autonomousregion and municipality) drug supervision and administration Bureau:

In order to thoroughly implement the “Opinions on Deepening the Reform of the Reviewand Approval System to Encourage the Innovation of Drugs and Medical Devices” (Tingzi [2017] No. 42) issuedbytheGeneral Office of the Central Committee of the Communist Party of China and the General Officeof theState Council, and to accelerate the innovation and development of the medical device industry, Inordertofurther accumulate experience in the full implementation of the medical device registrant system, onthebasis of the pilot work of the medical device registrant system in Shanghai, Guangdong and TianjinFreeTrade Zones, the State Drug Administration (hereinafter referred to as the National Bureau) has decidedtofurther expand medical device registration. The pilot work of the personnel systemis hereby notifiedasfollows: