GB9706 standards are important reference guidelines to the development and production of medical electrical equipment for selling in China.
The GB 9706.1-2020 medical electrical equipment Part 1: General requirements for basic safety and basic performance was issued on April 9, 2020. As of February 2023, the GB9706.1-2020 supporting standards consists a total of 67 mandatory standards and 2 recommended standards.
On March 16, 2023, the China National Medical Products Administration (NMPA) announced (No.14-2023) the related work implementation measures for GB9706.1-2020 and its supporting standards, namely the “parallel standards” and the “special standards”. The objective is to help applicants determine the deadlines of applicable standards in order to stay compliant in China:
Implementation date of GB9706.1-2020
- Applicants should keep in mind to check if there is a special standard applicable to the product, because the implementation date of the special standard can be referred to as the deadline to implement GB9706.1-2020 and parallel standards respectively.
- For cases when there is a new special standard applicable to the product but still in draft, applicants may wait until the official implementation date of the special standard is announced to determine the implementation date for GB9706.1-2020 and parallel standards.
- If there is no special standard applicable to the product, applicants should refer to May 1, 2023, as the implementation date for GB9706.1-2020 and parallel standards.
Change in registration / filing applications
- For new standards with implementation dates before December 31, 2025, the Chinese regulatory authority will grant a 3-year and 2-year extension period to applicants applying for change in registration or change in filing.
- If the implementation dates of special standards are after December 31, 2025, applicants shall complete the change in registration or change in filing before the deadline stipulated in the respective standard.
For registration or filing applications submitted after the new standard is implemented, testing reports should be prepared according to the new standard requirements.
For guidance on how the GB9706.1 affects your medical electrical equipment or for more information on our medical device and IVD registration services, please contact us.