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.

BradyKnows provides turn-key solutions to help overseas manufacturers facing the regulatory challenges in China. Pls contact us for any questions via info@bradyknowsmedical.com