China NMPA(former CFDA)recently 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).