The GB 9706.1-2020 <Medical electrical equipment - Part 1: General requirements for basic safety and essential performance > is vital for China to improve the safety and quality of active medical devices. GB 9706.1-2020 was therefore announced on 9th April 2020 and has been put into effect from 1st May 2023 onwards.

The respective announcement of the requirements can be found in attachment 1 below.

The detailed interpretations are provided in attachment 2 and the following key aspects are worth noting:

I. The time for implementation of the standard:

For products which apply to specialized standards of GB 9706.1-2020, GB 9706.1-2020 and collateral standards of GB 9706.1-2020 can be implanted simultaneously with the latest implemented specialized standard.

For products which do not apply to the specialized standards of GB 9706.1-2020, GB 9706.1-2020 and collateral standards of GB 9706.1-2020, they shall be implemented from 1st May 2023

II. Implementation of relevant standards for registration and filing:

  1. (1) For products which apply to the specialized standards of GB 9706.1-2020 that are implanted by 31st December 2025, or for products which do not apply to the specialized standards of GB 9706.1-2020:
    1. ● For products registered or filed before the implementation of the new standards, it is given a 3-year-transition-period and a 2-year-transition-period, respectively. For example, if the relevant specialized standard is implemented on 1st May 2024, the registered product shall be amended by 1st May 2027.
    2. ● For products registered or filed later than the implementation of the new standards, test reports that comply with the new standards shall be submitted and approved before the products are placed on the market.
  2. (2) For products which apply to the specialized standards of GB 9706.1-2020 that are implanted after 31st December 2025:
    1. ● For products registered or filed before the implementation of the new standards, no extension is provided for the amendment caused by the new standards. For example, if the applied standard is implemented on 15th Jan 2026, the registered/filed product shall be amended by the date of implementation.
    2. ● For products registered or filed later than the implementation of the new standards, test reports that comply with new standards shall be submitted and approved before the products are placed on the market.

Moreover, the information on inspection qualification certification for GB 9706 as of 1st March 2023 is provided in attachment 3.

 

Attachment:

  1. 1. NMPA Announcement on the implementation of GB 9706.1-2020 and related collateral standards and specialized standards (No. 14 of 2023).
  2. 2. Interpretation of the announcement on the implementation of GB 9706.1-2020 and related collateral standards and specialized standards.
  3. 3. Announcement on the relevant situation of the inspection qualification certification for GB 9706 series standards (March 2023).

 

 

Reference:

● NMPA Announcement on the implementation of GB 9706.1-2020 and related collateral standards and specialized standards (No. 14 of 2023)

Interpretation of the announcement on the implementation of GB 9706.1-2020 and related collateral standards and specialized standards

● Announcement on the relevant situation of the inspection qualification certification for GB 9706 series standards (March 2023)

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