Starting from 2020, impacted by the COVID-19, the China NMPA extended the supplemental phase for the medical device registration over one year.
In a recent notice from the NMPA, with the release of the COVID-19 prevention measures in China, the NMPA has changed the requirements for the supplemental phase as follows:
- For registration submission that received the supplemental notice before February 20, 2023, the supplementary phase will still be extended to 2 years.
- For registration submission that receives the supplemental notice after February 20, 2023 (including February 20), the supplemental phase will be reverted back to 1 year.
BradyKnows reminders medical device manufacturers to pay high attention on received date of your supplemental notice and response to the NMPA before the deadline to avoid rejection of the submission.
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