The Informatization and Normalization of NMPA

Since the electronic Regulated Product Submission (eRPS) system was implemented on June 24, 2019, CMDE has issued 2,626 Certificate Authority (CA) by December 31, 2019. The number of medical device registration applications submitted through online channels has reached 10,652, accounting for 80% of the total registration applications, which makes the working process more effective and convenient. In the future, CMDE will further expand the business scope of eRPS system and may include services such as domestic ClassⅡ medical device registration and Class I medical device filing. Bradynuoen could help evaluate and offer support on the registration.

Link: https://www.cmde.org.cn/CL0004/20764.html