The Electronic Regulated Product Submission (eRPS) was activated on 24th June 2019 and the business scope covered the medical device registration of domestic class III and imported class II & III devices, amendment, renewal, notification of IFU revision, special review of innovative medical devices etc.
To improve the online registration system, it is proposed to include corrective action of medical devices into the business scope of eRPS from 20th April 2023. The qualified registrants are encouraged to deal with the relevant business by eRPS.
Meanwhile, to guide the registrants in preparing the online submission dossier, Center for Medical Device Evaluation (CMDE) issued the structure for compiling the submission dossier related to corrective action, which can be found in the attachment.
NMPA Announcement on Adjusting the Business Scope of the Electronic Regulated Product Submission (eRPS) for Medical Device Registration (No. 11 of 2023)