GB 9706.1-2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance released on April 9, 2020 will come into force on May 1, 2023. All its supporting collateral standards have been released and its specialized standards are being released in succession. The implementation of the GB 9706.1-2020 series standards (hereinafter referred to as the new standards) will be of great significance to the overall improvement of the quality and safety of active medical devices in China. In order to steadily advance the implementation of the new standards, related work requirements are hereby announced as follows:

I.    Strictly implementing relevant standard requirements
Medical device registrants and filing parties shall carefully implement the requirements of the Standardization Law of the People’s Republic of China, the Regulation on the Supervision and Administration of Medical Devices, the Measures for the Administration of Registration and Filing of Medical Devices and the Measures for Supervision and Administration of Medical Device Production and ensure the relevant products they produce comply with compulsory standards and technical requirements for registered or filed products. Medical device registrants and filing parties are encouraged to implement the new standards in advance.

II.    Requirements for implementing standards related to registration and filing
(I)    For relevant products that GB 9706.1-2020 supporting specialized standards apply to, GB 9706.1-2020 and its supporting collateral standards may be implemented synchronously with the specialized standard finally implemented. For relevant products that GB 9706.1-2020 supporting specialized standards do not apply to, GB 9706.1-2020 and its supporting collateral standards shall be implemented from May 1, 2023.

(II)    For standards whose implementation date is before December 31, 2025 as stipulated in the notifications of relevant standards, product registration and filing shall be processed according to the following situations:

First, from the date of implementation of relevant standards specified in item (I), for Class III and Class II medical electrical equipment applied for registration for the first time, inspection reports showing conformance with the requirements of the new standards shall be submitted. For those whose applications for registration were submitted and accepted before this date, inspection, review and approval may be conducted according to the original standards.

For Class III and Class II medical electrical equipment approved for registration, applications for changes in registration shall be timely submitted, inspection reports showing conformance with the requirements of the new standards shall be submitted, and changes in product registration shall be completed according to the requirements of the new standards within three years from the date of implementation of relevant standards specified in item (I).

Second, from the date of implementation of relevant standards specified in item (I), for Class I medical electrical equipment processed filing for the first time, inspection reports showing conformance with the requirements of the new standards shall be submitted at the time of product filing.

For filed Class I medical electrical equipment, the time for changes in filing shall not exceed two years from the date of implementation of relevant standards specified in item (I) at the latest, and inspection reports showing conformance with the requirements of the new standards shall be submitted at the time of processing changes in filing.

(III) For specialized standards whose implementation date is after December 31, 2025 as stipulated in the notifications of relevant standards, relevant medical electrical equipment approved for registration or filed shall be completed changes in product registration or changes in filing according to the requirements of the new standards before the date of implementation of relevant standards specified in item (I).

III.    Requirements for implementing standards related to inspections

(I)    Inspection reports submitted at the time of applying for registration or processing filing can be self-inspection reports from the registration applicants or filing parties or inspection reports issued by qualified medical device inspection bodies entrusted by them.

(II)    Medical device inspection bodies shall associate inspection reports simultaneously issued in relation to GB 9706.1-2020 and supporting collateral standards or specialized standards and indicate sample consistency and product rectification in the inspection report remarks. Medical device inspection bodies without full inspection qualifications in relation to the new standards may subcontract inspections. Medical device inspection bodies capable of inspections in relation to relevant supporting collateral and specialized standards should actively undertake relevant subcontracted inspections. Inspection bodies that issue product inspection reports showing conformance with GB 9706.1-2020 and its supporting collateral standards or specialized standards shall be responsible for the inspection reports.

(III)    For major issues such as basic performance and criteria as well as typical model descriptions involved in the process of self-inspections or inspections by qualified medical device inspection bodies entrusted, relevant opinions shall be contained in the inspection reports for reference by the technical review departments.

(IV)    Medical device inspection bodies should make overall arrangements to ensure the inspections of products related to the implementation of the new standards and issue inspection reports within the contracted time limits.

IV.    Strengthening supervision and management of standard implementation

Medical products administration departments at different levels shall supervise and inspect the implementation of the new standards by registrants and filing parties as required in the Regulation on the Supervision and Administration of Medical Devices and its supporting rules from May 1, 2023. For those who have completed changes in registration or changes in filing, local medical products administration departments shall require the registrants or fling parties to organize production in strict accordance with compulsory standards and product technical requirements. For those who fail to complete changes in registration or changes in filing after the date of implementation stipulated in the notifications of the new standards, the registrants or filing parties shall make relevant commitments and complete changes in product registration or changes in filing within the time specified in the announcement. Local medical products administration departments shall strengthen supervision and guidance to ensure smooth and orderly implementation of the new standards.

The National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration NMPA) shall take the lead and work with relevant entities to establish an expert consulting mechanism, so as to timely study and solve major technical issues in the implementation of the new standards.

It is hereby announced.

Annex: Information Table of GB 9706.1-2020 and Supporting Collateral and Specialized Standards


National Medical Products Administration
February 28, 2023