Last Call For Testing & Modification Registration Of The GB 9706.1-2020 Standard Upgrade!

If your active medical device was approved by the China NMPA before 2021, most likely, you are not compliant with the newly upgraded Chinese national standard GB 9706.1-2020.

Standard Upgrade

The newly revised GB 9706.1-2020 Chinese standard will replace the GB 9706.1-2007 version. The newly upgraded GB 9706.1 standard is synchronized with the international standards IEC 60601-1:2012 (edition 3.1).

Implementation Date

At present, all seven parallel standards supporting GB9706.1-2020 have been released, and special standards are being released in batches. Regarding the implementation date of GB 9706.1-2020 and the supporting parallel standards, there are two key time points:

1. If the product does not involve special standards, the implementation date of GB 9706.1-2020 and the supporting parallel standards will be May 1, 2023.

2. If the product involves special standards, the implementation date of GB 9706.1-2020 will follow the implementation date of the special standards.

Cited from “GB 9706.1-2020 and its supporting juxtaposition and special standard implementation rules (draft for comments)”

For example, YY 9706.252-2021 standard (Medical electrical equipment — Part 2-52: Requirements for the basic safety and essential performance of medical beds) will be implemented on May 1, 2024, the implementation date of GB 9706.1-2020 for medical beds will be synchronized to May 1, 2024.

Major Changes

Compared with GB 9706.1-2007, the biggest change in the new version of the standard is the introduction of the concept of risk management, and the evaluation of basic performance is required. It is not enough to consider only basic safety, but also the basic performance of the product. A detailed comparison between the 2007 and 2020 version is available on request at info@bradyknowsmedical.com

Modification Registration

For medical device manufacturers who have products approved in China, you need to implement the standard upgrade by its implementation date. You need to complete China local testing, obtain test reports and submit a modification registration to the NMPA for approval. If you fail to complete the modification registration before the deadline, you will not be able to continue your sales in China and your future renewal registration will be jeopardized.

Considering the large difference between the 2020 version and 2007 version of the standard and the limited testing resources in China, to smoothly transition to the new version of the standard, it is recommended that you plan early and do adequate preparations.

If you have not started the testing and modification registration process for the GB 9706.1-2020 standard upgrade, call BradyKnows for help.

Initial Registration

For manufacturers who have ongoing product initial registration in China, please check if your type testing is following the GB 9706.1-2020 version standard. If not, you may need to start a GB 9706.1-2020 testing in parallel to your existing registration to make sure that your newly approved product will be compliant with the upgraded standards.