To implement the general office of the CPC Central Committee General Office of the State Council Opinions on deepening the reform of review and approval system and encouraging innovation of drugs and medical devices Hall word 2017 42number ,Realize the electronic declaration of medical device registration application,The State Drug Administration has organized the development of the electronic declaration information system for medical device registration eRPS .The matters related to the implementation of electronic declaration of medical device registration are hereby announced as follows
one Scope of application
at present,eRPSThe business scope of the system is the registration of medical devices of the State Drug Administration,Including domestic category III and imported category II Class III medical device registration Registration change Continuation registration,Clinical trial approval of class III high-risk medical devices,And notification of changes to medical device instructions Review of changes in medical device registration and licensing matters Special review of innovative medical devices, etc.
Filing of imported class I medical devices,Reissue of registration certificate and change document error correction Self cancellation Self withdrawal,Medical device registration, designated inspection and other matters are not included in theeRPSWithin the business scope of the system.
two Schedule
one CAapply
since2019year5Month on,Medical device registration applicant Registrant applicationeRPSDigital authentication certificate used with the system Certificate Authority,CA .Please pay attention to the website of the medical device technical evaluation center of the State Drug Administration for the specific application notice www.cmde.org.cn .
two System enable
2019year6month24day,Officially enabledeRPSsystem.Medical device registration applicant The registrant can make electronic declaration of online medical device registration,Paper materials are not required.meanwhile,The State Drug Administration shall retain the submission channels of paper materials.
2019year10month31Recently,The paper data shall be submitted according to the current medical devices In vitro diagnostic reagent registration and application materials are required.
2019year11month1From the day,Paper materials shall be submitted in accordance with Technical guide for electronic submission of medical device registration application Try out Requirements,Consistent with the form of electronic declaration catalogue.
See Annex for specific matters and requirements Electronic declaration information system for medical device registration eRPS Enable description .

It is hereby announced.

enclosure Electronic declaration information system for medical device registration eRPS Enable description

State Food and Drug Administration

2019year5month29day