NMPA Meeting on GB 9706 Standards Implementation

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 as follows:

1. To highlight the significance of implementing the 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. To fully implement the responsibility of registrants. Registrants shall strictly adhere to the new series of standards in accordance with the requirements and ensure that their products comply with those standards.
3. To fully implement the responsibility of medical device inspection agencies. All inspection agencies shall participate in training for the 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 prioritize handling them.
4. To 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.

Reference:

https://www.nmpa.gov.cn/yaowen/ypjgyw/20221014081216138.html