GB9706.1-2020 implementation has been explained further by the National Medical Products Administration (NMPA) in a recent Interpretation of the Circular on the Implementation of GB 9706.1-2020 (No.14-2023) which was announced on March 16, 2023.
The latest clarification addresses several questions on how to implement the new standards, supporting standards and concurrent standards for medical electrical equipment in China.
How to continue the registration if already registered before the implementation date of GB9706.1-2020 and its supporting standards?
For those who apply for renewal registration before the implementation date of the new GB9706 series standards specified in Notice No.14-2023, they can be evaluated for approval according to the requirements of the original standards. For those who apply for renewal registration after the implementation date of the new GB9706 series standards specified in Notice No.14-2023, they should be evaluated and approved according to the requirements of the new GB9706 series standards.
How to implement the new version of GB9706 series standards in product registration and filing work for specialized standards that are recommended standards?
The recommended standard GB/T9706.266 “Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems” has not yet been published. In order to encourage the implementation of the recommended standard, for the product registration work applicable to GB/T9706.266, GB9706.1-2020 and its supporting parallel standards can be chosen by the enterprise:
- If an enterprise chooses to implement GB/T9706.266, GB9706.1-2020 and its supporting parallel standards can be implemented together with GB/T9706.266 after its release.
- If the enterprise chooses not to implement GB/T9706.266, GB9706.1-2020 and its supporting parallel standards should be implemented from May 1, 2023.
For products with implementation dates of specialized standards after December 31, 2025, how will product registration and filing be carried out according to the new GB9706 series standards?
For proprietary standards with implementation dates after December 31, 2025, products that are first registered or filed for recordation after the implementation date of the relevant standards specified in Notice No.14-2023 shall submit inspection reports that comply with the requirements of the new version of the GB9706 series standards. For products that were registered and accepted before this date, inspections, evaluations, and approvals may be conducted in accordance with the original standards.
How to change the product manual and label for registered products?
After the product completes the registration or filing of changes in the new GB9706 series standards, it can modify the instructions and labels based on the change documents.
Further Information
Read our article on GB9706.1-2020 and its supporting standards.
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