The new version of GB9706 series standards is about to be fully implemented. How should medical device enterprises respond?
2022-10-21
After the release of the new version of GB9706.1 in 2020, China has successively issued 55 supplementary standards of 9706 series. Most of these standards are implemented on May 1, 2023. Active medical device enterprises should complete the changes and verification of the corresponding medical device products before May 1, 2023, in line with the requirements of the new version of 9706 series standards.
Compared with the new version of GB9706.1, the 2020 version and the 2007 version have been greatly changed from the structure to the content. It is necessary to provide risk management documentation to verify compliance with standards in the testing of medical devices.
New version 9706 also requires the identification of basic performance, basic performance identification process should be reflected in the risk management. If the basic performance is not identified, all the performance of the product is considered as the basic performance in the test process, which makes it difficult for the product to pass the EMC test.
Another intuitive change is the need to provide usability engineering documentation. The research on usability has less requirements in the past medical device research and development, so the enterprises have insufficient knowledge and consideration in this regard, which has become a major difficulty for enterprises to meet the requirements of the new 9706.
The new standard is about to be implemented, so how should active medical device enterprises deal with it?
1) Medical device products that have not yet been tested
As there are still about 7 months to go before the implementation of the new standard, during this period, it is very difficult for enterprises that have not yet submitted for inspection to quickly complete the preparation of registration data to complete the registration application and acceptance, so it is suggested that the products that have not yet completed the testing should be tested directly in accordance with the requirements of the new version of GB9706.
2）Medical device products that have obtained test reports but have not been registered for acceptance
For medical device products that have obtained test reports but have not been registered and accepted, if they can be accepted before May 1, 2023, they can directly use the report of the old version of GB9706.
3）Medical device products that have been registered
For medical device products that have completed registration, product technical requirements shall refer to mandatory standards in the form of “direct reference to specific contents of mandatory standard clauses”, “standard number” or “standard number + era number”.
In view of the significant changes in the content of GB9706, active medical device enterprises should apply for the change of registration. Some provincial bureaus can accept changes in mandatory standards during the extension, and the specific operation details can be communicated and confirmed with the local provincial bureaus. The active medical device products should meet the requirements of the new GB9706 series standards after May 1, 2023. Therefore, the test of the new GB9706 series should be completed before May 1, 2023 at least to ensure that the products can meet the requirements of the new standards, and the registration of changes should be completed as soon as possible.
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