Overview of Medical Device eRPS System in China

The eRPS system displays the current medical device registration application requirements in China, in the form of a directory listing (ToC) of the International Medical Device Regulators Forum’s (IMDRF) Regulated Product Submission (RPS) project, which will help guide registered applicants to submit medical device registration information.

Scope of Application

-Registration of domestic Class III medical devices / IVD reagents

-Registration of imported Class II and III medical devices / IVD reagents

-Continuation registration of domestic / imported medical devices / IVD reagents

-Alteration registration of domestic / imported medical devices / IVD reagents

-Clinical trial approval domestic / imported medical device / IVD reagents

-Special review of innovative medical devices

-Notification of alterations to medical device instructions

-Correction of alteration document of medical device / IVD reagent registration certificate

-Review of medical device / IVD reagents registration / license alteration

Key Benefits

1. Convenient for registered applicants to submit registration documents

The eRPS system can avoid trips or queues when submitting paper materials on site or by mail, and electronic filings are easier to carry and save.

2. Save review approval time and standardize the registration process

It can avoid the paper consumption, reduce the workload, and facilitate the simultaneous review of the project team. Electronic files can avoid artificially modifying replacement behavior because the system has a tracking function to record the operator and the operation process. And documents can be permanently retained for easy review and reference.

3. Complete and clear catalog of required materials

The category where the data is uploaded is further subdivided, and the corresponding data is uploaded according to the directory title. The system has a leak check function, so the data cannot be uploaded if it is incomplete.

4. Adopt CA ( Certification Authority ) to improve data security level

Only the recipient can read the information and the information will not be tampered with during the delivery process.

Directory Structure

Process and Associated Files

Release Time	Standards and Regulations
2019-05-07	Notice on Application for Collection of Digital Certificate (CA) for Medical Device Registration Electronic Declaration Information System
2019-05-31	Announcement on Implementing Electronic Declaration of Medical Device Registration (No. 46 of 2019); Notice on the Technical Guidelines for Electronic Declaration of Medical Device Registration Applications (No. 29 of 2019)
2019-06-06	Notice on Relevant Issues Concerning the Handling of Medical Device Registration Electronic Declaration Information System Business (No. 4 of 2019); Notice on the Structure of the Electronic Filing Directory Folder of the Medical Device Registration Electronic Declaration Information System (No. 5 of 2019)
2019-07-10	Notice on the Relevant Material Requirements for Electronic Declaration of Medical Devices (No. 41 of 2019); Notice of the "Medical Device Product Registration Project Filing Review Requirements (Trial)" (No. 42 of 2019)
2019-10-14	Notice on the Submission of Electronic Registration of Medical Device Registration and Prohibition of Repeated Submission (No. 15 of 2019)

Implementation Process

Since May 10 ^th , 2019 , medical device registration applicants could apply for the Digital Certificate (CA) for the eRPS system.

On June 24 ^th , 2019 , the eRPS system was officially launched. At the same time, the NMPA maintains the submission of paper materials.

From November 1 ^st , 2019 , the submission of paper materials shall be in accordance with the requirements of the "Technical Guide for Electronic Submission of Medical Device Registration Applications (Trial)", which is consistent with the form of the electronic filing catalog.

Declaration Process in eRPS System

More information about CA ( Certification Authority ) : http://www.cirs-md.com/news_and_events/10632.html