NMPA Latest Announcement On Implementation Of China GB 9706.1-2020 And Related Standards On March 16, 2023
2023-03-19
NMPA released the latest announcement on the implementation key issues of the new China GB 9706.1-2020 and collateral standards on March 16, 2023.
GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance has been released (IEC 60601-1:2012, MOD) on April 9, 2020, and will take effective since May 1, 2023. Its collateral standards have been released, and specialized standards are being published successively.
Implementation key issues for GB 9706 series standards taking effective:
For the products with applicable specialized standards of GB 9706.1-2020, GB 9706.1-2020 and collateral standards can be implemented simultaneously with the final specialized standards. For the products with no specialized standards, GB 9706.1-2020 and collateral standards will be implemented since May 1, 2023.
For the products with applicable specialized standards taking effective before December 31, 2025, or the products with no applicable specialized standards, the product registration and filing shall be handled in the following circumstances:
For the products that have obtained the registration certificate or filing, considering that the test of the new standard has been greatly affected by COVID since 2020, a 3-year extension period and a 2-year extension period have been given for the change registration or change filing of the product. For example, for the product with applicable specialized standard, if the effective date of specialized standard is May 1, 2024, the change registration of the registered product shall be completed before May 1, 2027, and the change filing of the filed product shall be completed before May 1, 2026; If there is no applicable specialized standards for the product, or the effective date of applicable specialized standard for the product is May 1, 2023, the corresponding change registration shall be completed before May 1, 2026, and the corresponding change filing shall be completed before May 1, 2025.
As for the products for new registration or new filing after the implementation of the new standards, the manufacturers shall submit the test report meeting the requirements of the new standards, and then can be approved for marketing only after obtaining the registration certificate or filing.
For the products with applicable specialized standards with the effective date after December 31, 2025:
Considering that the standard still has about 3 years of implementation transition period, the registrant and filing entity shall arrange the test and speed up the preparation before the implementation of the new standard.
For products that have obtained the registration certificate or filing before the effective date of new standards, no extension period will be granted to change registration or change filing. For example, the implementation date of the specialized standard is January 15, 2026, and the change registration or change filing of the product shall be completed by January 15, 2026.
Since May 1, 2023, NMPA departments at all levels will supervise and inspect the implementation of the new standards to enhance the regulatory surveillance.
