China NMPA Newsletter – March 2022


Featured Articles

Impacts From China Standard Update On Medical Device Registration

During the whole process of medical device lifecycle, the standards will be updated periodically. For example, GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD) was published in April, 2020, but will take effect since May 1, 2023.

How to handle such standard update during the registration? BradyKnows has helped overseas manufacturers conduct the test under new standard for new registration and certificate modification.

Below is the case study for different scenarios.

Scenario 1: Standard (e.g., GB 9706.1-2020) update during registration or modification

If the standard has been released, but not effective, as per recommendations from NMPA, the manufacturers submit the test report as per new standard. For more cautious practice, our clients are doing the two tests as per the old and new standard. The purpose for this practice is to avoid the test failure based on new standard. If fails in new standard, we can submit the test report based on old standard.

Scenario 2: Standard (e.g., GB 9706.1-2020) update during renewal

It is not very clearly how to handle standard update during renewal as per regulations. As per BradyKnows experiences, if the manufacturer has done substantial changes on product in order to comply the mandatory standard update, such as replacing critical components (Type A components), such changes are the scenario requiring certificate modification. Then, the manufacturer should apply the certificate modification first, followed by renewal. Some of our clients has experiences such scenarios that NMPA did not accept the renewal, so they should do modification first. If the mandatary standard updates will not make any substantial change on product, as per standard comparison and justification or new test, the product is in compliance with new mandatory standard, then during the renewal, a scenario statement and proof documents (such as standard justification or new test report) can be provided, rather than additional certificate modification first.

China New GCP Effective Since May 1, 2022

On March 31, 2022, NMPA officially released China new GCP (Medical Device Clinical Trial Quality Management Provisions, i.e., Medical Device Good Clinical Practice). The new GCP will take effective since May 1, 2022.

Key points in China new GCP are listed as below:


Key Updates In New Version Of China GMP Compared With Old Version

On March 22, 2022, NMPA published the updated version of China GMP (Good Manufacturing Practice) and GSP (Good Supply Practice). The new GMP and GSP will take effective since May 1st, 2022. BradyKnows QA team made assessment and summarized key updates in new version of China GMP compared with old version as below:

1.Fully implement the medical device registrant filing entity system, and strictly implement the main responsibility of the enterprise. The following impacts are mainly aimed at enterprises that entrust production.

2.Simplify relevant application materials and procedural requirements. The following impacts are mainly aimed at production enterprises.

3.Enrich and improve supervision means, improve operability, and solve practical problems in supervision.

4.Strengthen risk management and increase penalties for illegal acts.


NMPA Gives Full Support To China Real World Data Application Pilot Projects

On April 22, 2022, NMPA published a Communication Procedure for Medical Device Real World Data Application Projects in Hainan Boao Lecheng Medical Tourism Pilot Zone. As per this Procedure, NMPA will enhance the guide on medical device pilot program in Hainan to help apply RWD for China registration.

Hainan Medical Tourism Pilot Zone

Urgent Use Policy & RWD

What Products are Qualified ?


Hainan Pilot Zone Benefits: Commercial & Regulatory​

Real World Data Application​

NOTE: Currently, real world data cannot be used as sole clinical evidence; however, it can be used to support product registration as a supplement to existing evidence.


Resources – Documents Download