Recently, the State Pharmacovigilance Administration issued the Circular on the Implementation of GB 9706.1-2020 and Supporting Concurrent Standards and Special Standards (No. 14 of 2023, hereinafter referred to as the Circular). The background and relevant contents of the circular are explained as follows:
        
         1. Background
        
         GB 9706.1-2020 and supporting parallel standards, special standards (hereinafter referred to as the new GB 9706 series of standards) is an important guideline for medical device enterprises in China to develop and produce medical electrical equipment, which is of great significance to the overall improvement of the quality and safety level of active medical devices in China.
        
         GB 9706.1-2020 "Medical electrical equipment Part 1: General requirements for basic safety and basic performance" has been released on April 9, 2020, and all its supporting parallel standards have been released, and the special standards are being released gradually. As of February 2023, 69 standards in the new GB 9706 series have been released, with the exception of two (usability and closed-loop controllers) which are recommended standards, the remaining 67 are mandatory standards.
        
         In order to protect the high-quality development of the medical device industry and the safety of the public with the armament, and steadily promote the implementation of the new GB 9706 series of standards, the State Drug Administration issued Notice No. 14 of 2023, from the strict implementation of the relevant standard requirements, registration and filing-related standard implementation requirements, inspection-related standard implementation requirements, strengthen the supervision and management of the implementation of standards and other four aspects, the product registrant filer, technical review, inspection, the Supervision and management and other aspects of the work carried out a clear requirement.
        
         2. the relevant requirements of the registration and filing interpretation
        
         (A) on the implementation of the standard time point
        
         If a product has a special standard that applies to GB 9706.1-2020 (the "special standard" in the schedule of the notice), GB 9706.1-2020 and the accompanying parallel standards can be implemented simultaneously with the last implemented special standard. For example, the last special standard applicable to pulse oximetry equipment is YY 9706.261-2023 "Medical Electrical Equipment Part 2-61: Basic Safety and Basic Performance Special Requirements for Pulse Oximetry Equipment", for such products, GB 9706.1-2020 and the accompanying parallel standards can be implemented in parallel with YY 9706.261-2023 on January 15, 2026. YY 9706.278 "Medical electrical equipment Part 2-78: Basic safety and basic performance requirements for rehabilitation, assessment, compensation or relief medical robots" is under development and has not yet been published. For such products, GB 9706.1-2020 and the accompanying standards may be implemented at the same time as the implementation date specified in the standard release announcement.
        
         If the product does not apply to GB 9706.1-2020 supporting special standards, GB 9706.1-2020 and supporting parallel standards from May 1, 2023 implementation.
        
         (B) on the registration and filing of relevant standards implementation
        
         First, for products with applicable special standards, and the implementation date of the special standards release notice specified in the December 31, 2025, or products without applicable special standards:
        
         For the implementation of the new standard before the registration certificate has been obtained or has been for the record of the product, taking into account the new standard inspection work since 2020 by the epidemic, therefore, for the implementation of the new standard for the product to carry out changes to the registration or change the record, respectively, given a three-year and two-year extension period. For example, for products with applicable special standards, such as special standards issued by the announcement of the implementation date of May 1, 2024, the registered product change registration should be completed before May 1, 2027, has been filed in the product change filing should be completed before May 1, 2026; for products without applicable special standards, or products applicable to the implementation date of the special standards for May 1, 2023 For products without applicable special standards, or products with a special standard implementation date of May 1, 2023, the corresponding change in registration should be completed before May 1, 2026, and the corresponding change in filing should be completed before May 1, 2025.
        
         For the first application for registration or filing of medical devices after the implementation of the new standard, the product should be submitted to meet the requirements of the new standard inspection report, obtain a registration certificate or for the record before listing.
        
         Secondly, for products with applicable special standards, and where the implementation date specified in the announcement of the release of the special standards is after 31 December 2025:
        
         Considering that there is still a transitional period of about three years for the implementation of the standard, and the comprehensive department of the State Drug Administration and the General Office of the State Administration of Market Regulation jointly issued the "Notice on Promoting Capacity Building of Medical Device Inspection Organizations to Safeguard the Qualification of the New Version of GB 9706 Series Standard" (Drug Administration Comprehensive Arm Note [2022] No. 87), jointly deploying to promote the qualification of the new version of GB 9706 series standard; registrants The registrant should make reasonable arrangements to expedite the preparation work before the implementation of the new standard.
        
         For products that have obtained a registration certificate or have been filed before the date of implementation of the new standard, the extension period will no longer be granted for the implementation of the new standard and the change of registration or change of filing. For example, if the implementation date of the applicable special standard is January 15, 2026, the product that has obtained the registration certificate should complete the change of registration before January 15, 2026, and the product that has been filed should complete the change of filing before January 15, 2026.
        
         For products that first apply for registration or for filing after the implementation of the new standard, they should submit inspection reports that meet the requirements of the new standard and obtain a registration certificate or apply for filing before they can be listed.
        
         3. on the expert consultation mechanism
        
         Led by the China Academy of Food and Drug Administration (State Drug Administration Medical Device Standards Management Center), in conjunction with the State Drug Administration Medical Device Technical Review Center, the relevant standards under the Medical Device Standardization Technical Committee, the establishment of expert consultation mechanism, timely research to solve the new GB 9706 series of standards implementation of major technical issues.
        
         For the full implementation of the new GB 9706 series of standards of the overall, common issues, China Academy of Food and Drug Administration (State Drug Administration Medical Device Standards Management Center) to take the lead in organizing the drafting of explanatory documents, in order to help unify the understanding and awareness of the standard, standardize the implementation scale, and promote the smooth implementation of the standard.

Content source: State Medical Products Administration