Qserve China is officially launching Certificate Authority (CA) for NMPA E-submission

China’s National Medical Products Administration’s (NMPA), formerly referred to as  CFDA, Electronic Regulated Product Submission system (e-RPS) went live on June 24, 2019 with transition time until the 31st of October 2019. This new electronic system is intended to replace on-site paperwork submissions. Starting on the 1st of November 2019, most NMPA applications will only be accepted through Certificate Authority (CA) on the new electronic platform. Qserve has this digital certificate in hand for login, submission, signature/stamp authorization, and status/record tracking. 

What is CA?

CA is a certified USB stick inserted in an applicant’s computer for secured digital document transfer and application. CA is a legal valid corporate stamp that shall be carefully controlled by the applicant.

Who should apply for CA?

Domestic class III medical device or IVD manufacturers, and/or Chinese agents for imported medical devices or IVDs.

If a domestic manufacturer is also a Chinese agent for other imported devices, the company would still apply for only one CA and choose corresponding registration route based on the actual situation.

If a foreign manufacturer appoints several Chinese agents for a number of applications, each of their Chinese agents needs to apply for their own CA.

How to apply for CA?

Applications can be submitted through the NMPA website Once the CA application is approved, the applicant needs to appoint a representative employee within 60 working days of the acceptance notice, in order to collect the CA on-site.  Otherwise, a new application is required.

What the scope of the CA?

CA includes initial registration, supplement, renewal, amendment/change, high-risk Class III devices’ clinical trial request, modification of Instruction for Use (IFU), and Innovation Approval applications.

Application packages, including technical dossiers, should be submitted online and available for the assigned reviewer at the Centre for Medical Device Evaluation (CMDE).

New applications through CA will not impact ongoing project processes or old approved registration records. CA entrance only lists applications submitted under the ERPS system.

How to login to ERPS?

There are two routes to login, one is through the ERPS website, and another is to download and install the client setup. The table below summarizes the differences between the two approaches.


Website log in

Client setup log in

CA insertion requirement:


Not Required: X

Not available: N/A

Link with directory


Fill in application form


Submit new application


Submit supplementary dossiers



Technical File preparation off-line


Export Technical File


Project status review and track

All products registered under ERPS

Only projects registered under client setup


Activities not covered by CA include:

  • Class I and class II domestic applications
  • Class I imported product filing
  • Replacement, correction, self-deregistration, and self-revocation of certificates, regardless of classification or domestic/foreign nature.

NMPA is expected to expand applied areas of using CA, such as making technical consultation appointments, and integrating CA with other existing NMPA functions in the near future.



  1. Technical guidelines for electronic submissions found in Order 29 (2019)
  2. Notice on the Application of Certificate Authority (CA) certificate for Medical Device Registration Service Platform (2019)
  3. Notice on Implementation of Electronic Submission System for Medical Device Registration” and “Technical Guideline on Registration Material Requirements for Electronic Submission System”.
Stephanie (Xing) Huang
Post date: July 01, 2019
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