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.
For more questions, please contactinfo@bradyknowsmedical.com.