Recently, the State Food and Drug Administration issued the “Notice on the Implementation of GB 9706.1-2020 and its supporting parallel standards and special standards” (No. 14 of 2023, hereinafter referred to as the “Notice”). The background and relevant content of the announcement are hereby explained as follows:
1. Background
GB 9706.1-2020 and supporting parallel standards and special standards (hereinafter referred to as the new GB 9706 series of standards) are important guidelines for the development and production of medical electrical equipment by my country’s medical device companies, and are of great significance to the overall improvement of the quality and safety of my country’s active medical devices.
GB 9706.1-2020 “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance” was released on April 9, 2020. All the supporting parallel standards have been released, and special standards are being released gradually. As of February 2023, the new version of GB 9706 series standards has released 69 items, except for 2 items (usability, closed-loop controller) which are recommended standards, and the remaining 67 items are mandatory standards.
In order to ensure the high-quality development of the medical device industry and the safety of public devices, and steadily promote the implementation of the new version of the GB 9706 series of standards, the State Food and Drug Administration issued a circular No. 14 in 2023. The four aspects of standard implementation requirements and strengthening the supervision and management of standard implementation put forward clear requirements for the work of product registrants, record holders, technical review, inspection, supervision and management.
2. Interpretation of relevant requirements for registration and filing
(1) About the implementation time of the standard
If the product has specific supporting standards applicable to GB 9706.1-2020 (“Special Standards” in the attached table of the announcement), GB 9706.1-2020 and supporting parallel standards can be implemented simultaneously with the last specific standards implemented. For example, the last applicable standard for pulse oximeter equipment is YY 9706.261-2023 “Medical Electrical Equipment Part 2-61: Special Requirements for Basic Safety and Basic Performance of Pulse Oximeter Equipment”. For this type of product, GB 9706.1- 2020 and supporting parallel standards can be implemented simultaneously with YY 9706.261-2023 on January 15, 2026; the special standard YY 9706.278 “Medical Electrical Equipment Part 2-78: Rehabilitation, Evaluation” applicable to medical robots for rehabilitation, evaluation, compensation or relief , Compensation or mitigation of the special requirements for the basic safety and basic performance of medical robots” is being formulated and has not yet been released. For this type of products, GB 9706.1-2020 and supporting parallel standards can be implemented simultaneously on the implementation date stipulated in the announcement of the YY 9706.278 standard.
If the product does not have special supporting standards for GB 9706.1-2020, GB 9706.1-2020 and supporting parallel standards will be implemented on May 1, 2023.
(2) Regarding the implementation of relevant standards for registration and filing
First, there are applicable special standards for the product, and the implementation date specified in the announcement of the special standard is before December 31, 2025, or there is no applicable special standard for the product:
For products that have obtained registration certificates or have been filed before the date of implementation of the new standard, considering that the inspection work of the new standard has been greatly affected by the epidemic since 2020, the change registration or change filing of the product for the implementation of the new standard , were given a 3-year and 2-year extension period. For example, if there are special standards applicable to the product, if the implementation date stipulated in the announcement of the special standards is May 1, 2024, the registration of changes to registered products shall be completed before May 1, 2027, and the filing of changes to filed products shall be Completed before May 1, 2026; if there is no applicable special standard for the product, or the implementation date of the applicable special standard for the product is May 1, 2023, the corresponding change registration shall be completed before May 1, 2026, and the corresponding change shall be filed It should be completed by May 1, 2025.
For products that apply for medical device registration or filing for the first time after the date of implementation of the new standard, an inspection report that meets the requirements of the new standard should be submitted, and the market can only be marketed after obtaining a registration certificate or filing.
The second is that there are special standards applicable to the product, and the implementation date stipulated in the announcement of the special standards is after December 31, 2025:
Considering that there is still a transition period of about 3 years for the implementation of the standard, and the General Office of the State Food and Drug Administration and the General Office of the State Administration for Market Regulation jointly issued the “Notice on Promoting the Capacity Building of Medical Device Inspection Institutions to Guarantee the Qualification of the New Version of GB 9706 Series Standards” “(Pharmaceutical Administration Comprehensive Machinery Note [2022] No. 87), jointly deploy and promote the qualification certification of the new version of GB 9706 series standards; registrants and filers should arrange time reasonably and speed up the preparations before the implementation of the new standards.
For products that have obtained registration certificates or have been filed before the date of implementation of the new standards, no extension period will be given for changes in registration or change of records to implement the new standards. For example, the implementation date of the special standards applicable to the product is January 15, 2026, the product that has obtained the registration certificate should complete the change registration before January 15, 2026, and the product that has been filed should complete the change record before January 15, 2026 .
For products that apply for registration or filing for the first time after the date of implementation of the new standard, an inspection report that meets the requirements of the new standard should be submitted, and the market can only be marketed after obtaining a registration certificate or filing.
3. About the expert consultation mechanism
Led by the China National Institutes for Food and Drug Control (Medical Device Standards Management Center of the State Drug Administration), together with the Medical Device Technology Review Center of the State Drug Administration and the Medical Device Standardization Technical Committee under the jurisdiction of relevant standards, an expert consultation mechanism was established to conduct timely research Solve major technical problems in the implementation of the new GB 9706 series standards. Regarding the overall and common problems of the full implementation of the new version of the GB 9706 series of standards, the China Institute for Food and Drug Control (Medical Device Standard Management Center of the State Drug Administration) took the lead in organizing the drafting of explanatory documents to facilitate a unified understanding of the standards. Standardize the implementation scale and promote the smooth implementation of standards.