Medical Device Go back »

2023-10-18 | All chapters

Due to the limited workload of testing institutes and relevant government departments, many medical devices could not fulfil the tests and registration requirements of the State Council’s Decree 739, Measures for the Supervision and Administration of Medical Device Manufacturing by the deadline of 1^st May 2023.

The European Chamber Healthcare Equipment Working Group has been advocating on this issue since 2022, calling for solutions by maintaining close communication and cooperation with the National Medical Products Administration (NMPA). On 16^th March 2023, the NMPA published the Implementation Measures for GB9706.1-2020 and its Supporting Standards (Announcement #14/2023), which grants a three-year extension for the completion of product registration changes, providing the industry with sufficient time to complete the implementation of the new standards and avoid compliance risks.

For more information on the Healthcare Equipment Working Group, please click here.