NMPA Notice On Expansion Of The Pilot Medical Device MAH

NMPA in Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, Shaanxi provinces (autonomous regions and municipalities) Bureau:

In order to thoroughly implement the “Opinions on Deepening the Reform of the Review and
Approval System and Encouraging Innovation in Drugs and Medical Devices” issued by the General
Office of the Central Committee of the Communist Party of China and the General Office of the
State Council (No. [2017] 42), we will accelerate the development of the medical device industry
innovation and development. Implementing the medical device MAH to further accumulate
experience. Based on the pilot work of the medical device MAH in the Shanghai, Guangdong, and
Tianjin Free Trade Zones, the NMPA (hereinafter referred to as the National Bureau) decided to
further expand the medical device MAH for the pilot work, the relevant matters are hereby notified
as follows:

The scope of the pilot

Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, Shaanxi provinces (autonomous regions, municipalities).