GB 9706.1-2020 Standards Interpretation

This article is focus on how to deal with the renewal of existing registrations, the adoption of new and recommended standards, and the modification of product instructions and labels.

1. Renewal of Existing Registrations: If medical devices applying for registration renewal can’t meet the new mandatory standards, the renewal will not be granted. Existing registrations will continue to be valid if they meet all requirements, and renewal should be applied for 6 months before the expiry of the validity period.

2. Implementation of New Standards: Products applying for renewal before the implementation date of the new standards can be reviewed and approved according to the original standards. However, those applying after the new standards are implemented will have to adhere to the new version of the GB 9706 series of standards.

3. Special Recommended Standards: For recommended standards like GB/T 9706.266, enterprises have the choice to implement it or not. If chosen, it can be implemented alongside other parallel standards.

4. Special Standards with Future Implementation Dates: For standards with an implementation date after December 31, 2025, products applying for registration for the first time should meet the new GB 9706 series of standards.

5. Changes in Product Instructions and Labels: After completing the change registration based on new standards, companies are allowed to modify their product instruction manuals and labels.

For more information about the standard GB9706.1-2020, please contact us at info@gvmmedical.com.