Background
Due to the limited workload capacity of testing institutes and relevant government departments, many medical devices were unable to fulfil the testing and registration requirements under the State Council’s Decree 739, Measures for the Supervision and Administration of Medical Device Manufacturing, by the deadline of 1st May 2023. This posed significant compliance challenges for the industry.
Result
Since 2022, the European Chamber Healthcare Equipment Working Group has been actively advocating for solutions by maintaining close communication and cooperation with the National Medical Products Administration (NMPA).
On 16th March 2023, the NMPA published the Implementation Measures for GB9706.1-2020 and its Supporting Standards (Announcement No. 14/2023), granting a three-year extension for completing product registration changes.
Impact
- Provided sufficient time for companies to comply with updated standards;
- Reduced compliance risk for medical device manufacturers;
- Demonstrated effective policy adjustment through industry-government collaboration.
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