NMPA held a meeting to promote the implementation of the GB 9706 series standards on October 13th, 2022.
Since April 2020, GB 9706.1-2020 “Medical electrical equipment – Part 1: General requirements for safety and performance” and supporting regulations have been released one after another and will be implemented from May 1st, 2023. The new series of standards has 76 items, and the main purposes are the following:
1. To identify the significance of implementation of new series standards. Changes in standards not only have significant impacts on the medical device industry, but also bring up higher requirements for related administration.
2. Fully implement the responsibility of registrants. Registrants shall strictly implement the new series of standards in accordance with the requirements and ensure that the products comply with the requirements of the standards.
3. Fully implement the responsibility of the medical device inspection agencies. All inspection agencies shall participate in training for new standards to ensure that inspectors can master and apply relevant standards to carry out inspections. For inspection applications related to the new series of standards, all inspection agencies should give priority to handling them.
4. Fully implement the responsibility of provincial medical products administrations. All provincial medical products administrations should analyze the actual conditions for the implementation of the new series of standards, formulate specific measures and ensure the effective implementation of the new series of standards.