gb9706.1-2020 standard

GB 9706.1-2020 "medical electrical equipment Part 1: basic safety and basic performance of the General Requirements", issued by the State Drug Administration on April 9, 2020, since May 1, 2023, its supporting side-by-side standards have been released, the special standards are being released batch by batch. Up to now, GB 9706.1-2020 series of standards have been released 59, in addition to 2 (availability, closed-loop controller) for the recommended standards, the remaining 57 are mandatory standards. One of the general standards, seven parallel standards and 39 special standards will be implemented on May 1, 2023, eight special standards will be implemented on May 1, 2024 or August 1, four special standards will be implemented on May 1, 2025 or June 1,. At the regulatory level, the "supervision and management of the production of medical devices" Article 39 provides that, after the implementation of the new mandatory standards, the medical device registrant, the filing should be timely identification of the differences between the technical requirements of the product and the mandatory standards, the need to change the registration or filing changes should be in accordance with the provisions of the registration and filing regulations for the relevant procedures. In the "medical device registration and filing management measures" of Article 83, the new mandatory standards for medical devices issued and implemented, apply for renewal of registration of medical devices can not meet the new requirements, not renewed registration. At the same time, the "medical device registration and record management measures" Article 82 provides that the expiration of the registration certificate for medical devices need to continue the registration, the registrant should be in the expiration of the certificate of registration of medical devices before the expiration of six months, to the original registration department to apply for renewal of registration, and in accordance with the relevant requirements for the submission of the application information. Therefore, the registration applicant should be in accordance with the provisions of the above regulations and combined with the implementation date of the GB 9706.1-2020 series of standards, and actively identify the product to comply with the new mandatory standards for the changes made in the "Registration and Filing of Medical Devices Management Measures" (State Market Supervision and Administration Decree No. 47) in the provisions of the circumstances that should be dealt with for the change of registration. If it is in line with the change of registration, the applicant for registration should prepare the relevant information and submit the application for change of registration in accordance with the requirements of Annex 7 of the Announcement on the Publication of the Requirements for the Declaration of Information for Registration of Medical Devices and the Format of Approval Certification Documents (No. 121 of 2021). GB 9706.1-2020 series of standards and implementation dates can be found in the "Data Query" section of the website of the Standards Management Center of the China Academy of Food and Drug Control.