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China launches electronic registration system for medical device approval

China NMPAformer CFDArecently announced that the implementation of Electronic Regulated Product Submission system (e-RPS) will come into effect on June 24, 2019.  The format and arrangement of content stipulated are now part of the regulatory requirements to file for NMPA submission.

The e-RPS system was initially proposed by IMDRF (International Medical Device Regulators Forum) work group in March 2012.  China, as an IMDRF member and 2018 rotating presidency, agreed to adopt these documents, and adapt them to meet local regulatory requirements where appropriate.  

Following the announcement, NMPA issued a series of notices, that further explain the adoption and implementation of the policies and concepts in IMDRF documents within the NMPA’s regulatory framework. These include Notice on Implementation of Electronic Submission System for Medical Device Registration (No. 46, 2019), Technical Guideline on Registration Material Requirements for Electronic Submission System trial version (No. 29, 2019), Notice on Processing of Medical Device Registration Electronic Declaration Information System (No. 4, 2019), and Notice on the structure of folders of RPS ToC (No. 5, 2019).

Why China adopt the e-RPS

- To keep pace with internationally harmonized format for use when filing medical device submissions for various market approval;

- To lift the burden of carrying heavy documents and traveling to Beijing for on-site submission;

- To facilitate technical files access and exchange across NMPA departments and quicker search function to improve review efficiency;

- To further standardize the submission technical requirements, and consider regulatory inputs from product design and development phase;

- To strengthen Post Market Surveillance. NMPA officers can easily go back to the records in pre-market submission when the adverse events or vigilance occur;

-  To secure data transmission and storage of paperless working;

Key Timeline of action transitional period

Before 24th June 2019

Option 1: submit paperwork version as current practice with no change

Option 2: submit E-filing online under e-RPS structure, with no paperwork

After 24th June 2019, but before 31th October 2019

Option 1: submit paperwork version as current pratice, plus a e-copy of e-RPS structured files stored in a USB stick

Option 2: submit E-filing online under e-RPS structure, with no paperwork

From 1st November 2019

Option 1: submit paperwork version built up according to e-RPS structure, plus an e-copy of e-RPS structured files stored in a USB stick

Option 2: submit electronic version online under e-RPS structure, with no paper version

* For option 2, legal manufacturers and/or its China agent need to apply for a Certificate Authority (CA), a digital key, to access the e-RPS System and affix stamp electronically.

What are the differences

ERPS is in principle not introducing new regulatory requirements.  However, the Table of Contents (ToC) and the classification matrix are comprehensive in nature, so e-RPS may appear to include some new requirements.  Besides, although not all headings are required for all submission types, numbering of headings remain consistent regardless of whether the heading is required or not.

The hierarchical presentation of China submission is the same as IMDRF structure, which has common contents and regional elements.  The headings, code, content explanation, and display name are also the same, but provided in Chinese language.  Some regional specific elements are adapted to China situation, which are reflected in Row ID 1.01, 1.04, 1.06, 1.07, 1.10, 1.12.05, 1.12.07, 1.14, 2.02, 3.04.01, 3.04.02, 3.05.08, 3.05.09, 3.07, 4.02, 5.02, 5.03, and 6A.03.02.  Additional variations such as the combination products, and the request approval to conduct clinical trials for high-risk products are also covered in e-RPS scope in China.

NMPA will monitor the use of these structures and continually improve the documents based on China users’ feedback and experience.

Affected submissions and listings categories

The e-RPS system affects domestic class III, imported class II and III, medical devices and IVDs. The table below shows the applicable scopes

Number

Item

Description

1

Domestic Products

Domestic class III Non-IVD Initial application

2

Domestic class III IVD Initial application

3

Domestic class III Non-IVD Change Application with Registry

4

Domestic class III Non-IVD Change Application with Permission

5

Domestic class III IVD Change Application with Registry

6

Domestic class III IVD Change Application with Permission

7

Domestic class III Non-IVD Renewal Application

8

Domestic class III IVD Renewal Application

9

Domestic class III High-risk Product Clinical Trial Pre-Approval Application

10

Foreign Products

Foreign class II & III Non-IVD Initial application

11

Foreign class II IVD Initial application

12

Foreign class III IVD Initial application

13

Foreign class II & class III Non-IVD Change Application with Registry

14

Foreign class II & class III Non-IVD Change Application with Permission

15

Foreign class II & class III IVD Change Application with Registry

16

Foreign class II & class III Non-IVD Change Application with Permission

17

Foreign class II & class III Non-IVD Renewal Application

18

Foreign class II & class III IVD Renewal Application

19

Foreign class III High-risk Product Clinical Trial Pre-Approval Application

20

Others

Notification of Changes in IFU

21

Review of Change with Registry and Permission Application

22

Special Procedure for Innovative Medical Device Application

Qserve Group China can help you establish the e-RPS format documents, consult with NMPA on your behalf, do the submission, and take the role to support or be your legal China agent. For any inquiries, please email info@qservegroup.com.

Reference:

Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVDMAToC)

In Vitro Diagnostic Device Market Authorization Table of Contents (lVDMAToC)Notice on Implementation of Electronic Submission System for Medical Device Registration (No. 46, 2019)

Technical Guideline on Registration Material Requirements for Electronic Submission System trial version (No. 29, 2019)

Notice on Processing of Medical Device Registration Electronic Declaration Information System (No. 4, 2019)

Notice on the structure of folders of RPS ToC (No. 5, 2019). 

Stephanie (Xing) Huang
Post date: September 01, 2019
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