To implement the relevant policies set forth in the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Review & Approval System to Encourage the Innovation of Drugs and Medical Devices (General Office [2017] No.42), and to realize the electronic application of medical device registration, NMPA has organized the development of the electronic Regulated Product Submission (eRPS) system, and announced the relevant issues as follows on May 31, 2019:
I. Scope of application
At present, the eRPS system business scope covers the NMPA medical device registration affairs, including the registration, change in registration and registration renewal of domestic Class III medical devices, imported Class II and Class III medical devices; the examination and approval of clinical trials for Class III high-risk medical devices; notification for revising medical device instructions; re-review of registration of medical devices and change of licensing items; and special review of innovative medical devices, etc.
The record filing of imported Class I medical devices; the replacement, correction, self-deregistration, and self- revocation of registration certificates and change documents; and the designated test for medical device registration, etc., are not included in the scope of the eRPS system.
II. Time schedule
(I) CA application
Since May 2019 , the applicants and registrants of medical device registration can apply for a Certificate Authority (CA) for use in the eRPS system. Please pay attention to the website of the NMPA Center for Medical Device Evaluation (www.cmde.org. cn) for specific notification of application.
(II) System startup
On June 24, 2019, the eRPS system was officially launched. Medical device registration applicants and registrants can apply for online electronic registration of medical devices without submitting paper dossiers. Meanwhile, NMPA reserves the means of submitting paper dossiers.
The submission of paper materials may follow the current requirements for registration of medical devices and in vitro diagnostic reagents prior to October 31, 2019;
From November 1, 2019, the submission of paper materials shall abide by the requirements of the Technical Guidelines for Electronic Submission of Medical Device Registration Applications (Interim) in alignment with the electronic filing form.
