GB 9706.1-2020 "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Basic Performance" was issued on April 9, 2020 and has been implemented since May 1, 2023. Its supporting parallel standards have been fully issued, and special standards are being issued in succession. The implementation of the GB 9706.1-2020 series of standards (hereinafter referred to as the new standards) is of great significance to the overall improvement of the quality and safety level of active medical devices in China. In order to steadily promote the implementation of the new standard, the relevant work requirements are hereby notified as follows:

1、 Strictly implement relevant standard requirements

The registrant of medical devices shall conscientiously implement the requirements of the Standardization Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, the Administrative Measures for the Registration and Filing of Medical Devices, and the Administrative Measures for the Supervision and Administration of the Production of Medical Devices, to ensure that the relevant products they produce comply with mandatory standards and the technical requirements of registered or filed products. Encourage medical device registrants to implement the new standards in advance.

2、 Implementation requirements for registration and filing related standards

（1） If the product is applicable to the supporting special standards of GB 9706.1-2020, GB 9706.1-2020 and the supporting parallel standards can be implemented simultaneously with the final implemented special standards. If there is no applicable GB 9706.1-2020 supporting special standard for the product, GB 9706.1-2020 and the supporting parallel standard will be implemented on May 1, 2023.

（2） For standards whose implementation date specified in the relevant standard release announcement is before December 31, 2025, product registration and filing shall be handled according to the following circumstances:

First, from the date of implementation of the relevant standards specified in paragraph (1), for Class III and Class II medical electrical equipment that apply for registration for the first time, inspection reports that meet the requirements of the new standards should be submitted. Those who apply for registration and have been accepted before may undergo inspection, review and approval in accordance with the original standards.

"For Class III and Class II medical electrical equipment that have been approved for registration, they shall promptly apply for change of registration, submit inspection reports that meet the requirements of the new standard, and complete product change registration in accordance with the requirements of the new standard within 3 years from the date of implementation of the relevant standards specified in paragraph (1).".

Second, since the implementation date of the relevant standards specified in paragraph (1), for Class I medical electrical equipment that has been filed for the first time, an inspection report that meets the requirements of the new standard should be submitted when the product is filed.

For Class I medical electrical equipment that has been filed, the time for filing changes shall not exceed 2 years from the date of implementation of the relevant standards specified in paragraph (1). When filing changes, an inspection report that meets the requirements of the new standard shall be submitted.

（3） For special standards whose implementation date specified in the relevant standard release announcement is after December 31, 2025, medical electrical equipment that has been approved for registration or filed shall complete product change registration or change filing in accordance with the requirements of the new standard before the implementation date of the relevant standard specified in paragraph (1).

3、 Implementation requirements for inspection related standards

（1） The inspection report submitted when applying for registration or filing may be a self-inspection report from the registration applicant or the filing person, or may be an inspection report issued by a qualified medical device inspection institution entrusted by the registration applicant or the filing person.

（2） The medical device inspection institution shall associate the inspection reports issued simultaneously with GB 9706.1-2020, supporting parallel standards, and special standards, and specify the consistency of the samples submitted for inspection and the product rectification in the inspection report notes. Medical device inspection institutions that do not have the qualification for the full range of new standard inspections can implement subcontracting inspections. Medical device inspection institutions that have the ability to undertake relevant matching and special standard inspections should actively undertake relevant subcontracting inspections. The inspection agency shall issue a product inspection report that conforms to GB 9706.1-2020, supporting parallel standards, and special standards, and shall be responsible for the inspection report.

（3） For major issues such as basic performance and criteria, model typicality descriptions, etc. involved in the process of self inspection or commissioning a qualified medical device inspection institution, relevant comments should be included in the inspection report for reference by the technical review department.

（4） Each medical device inspection institution shall make overall arrangements to ensure the implementation of the new standard and the inspection of related products, and issue an inspection report within the time limit agreed in the contract.

4、 Strengthen the supervision and management of standard implementation

Starting from May 1, 2023, drug regulatory authorities at all levels should conscientiously supervise and inspect the implementation of new standards by registrants in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and its supporting regulations. For those who have completed the change registration or change filing, the local drug regulatory department shall require the registrant's registrant to organize production in strict accordance with mandatory standards and product technical requirements; For those who have not completed the change registration or change filing after the implementation date specified in the announcement of the new standard, the registrant's registrant shall make relevant commitments and complete the product change registration or change filing within the time specified in the announcement. The local drug regulatory department shall strengthen supervision and guidance to ensure the smooth and orderly implementation of the new standard.

The China Institute for Food and Drug Control (China National Drug Administration Medical Device Standards Management Center) takes the lead in establishing an expert consultation mechanism with relevant units to promptly study and solve major technical issues related to the implementation of the new standard.

It is hereby announced.

Annex: Information Sheet of GB 9706.1-2020 and Supporting Parallel Standards and Special Standards

State Drug Administration

February 28, 2023