Medical Device Electronic Submission System (eRPS)

On 31.05.2019 and 06.06.2019, the NMPA (National Medical Products Administration) and CMDE (Center for Medical Devic Evaluation) released three announcements regarding the eRPS (NMPA No. 46-2019; CMDE No. 4-2019; CMDE No. 5-2019). The eRPSystem serves the electronic management of medical device registrations. Starting on 01.11.2019, all documents for class II and III registration, change and renewal applications shall be submitted through this system. No hard copy documents will be accepted – except for class I medical devices. In order to log into the eRPS, a CA (Certificate Authority) has to be applied for. Once a CA is received, the applicant is only allowed to use the eRPS for further applications.