China’s Medical Device Supplementary Notice Period reverts to a one-year period following its temporary extension to a 2-year period.
As part of the Chinese government’s ongoing efforts to adjust registration processes during the Coronavirus epidemic, the National Medical Products Administration (NMPA) had granted an additional one-year extension to provide supplementary information. The supplementary notice requires medical device manufacturers to submit additional supporting information for their medical device registration applications.
This additional one-year extension has now been withdrawn as the China moves back to normality.
This means that:
- if a Medical Device Supplementary Information Notice is received from the NMPA before February 20, 2023, the period for providing the supplementary information is 2 years – the initial year plus a one-year extension
- if a Medical Device Supplementary Information Notice is received from the NMPA on or after February 20, 2023, the time limit for providing the supplementary information is 1 year only.
It is important to be aware of these changes and to actively prepare the necessary supplementary information, should you receive a notification from the NMPA. This will help to ensure timely submission of relevant information otherwise the registration application will be rejected. This clearly has implications for medical device and IVD manufacturers who are asked to undertake long-term tests or supplementary clinical trials.
The process should you receive a request for Supplementary Information is:
- The NMPA will only issue a Supplementary Notice Request once
- After receiving the NMPA’s request, registration applicants must submit the supporting additional documents for completeness in one go within the time limit of one year
- Applicants can request up to three online consultation meetings with the NMPA during the one-year period
- Before the final submission, registration applicants are allowed to request a Pre-Assessment from NMPA.
Read the original CMDE announcement on medical device supplementary notice period adjustments in China.
At Cisema, we understand the complexity of navigating these regulatory changes and the importance of compliance with all requirements. Our team of experts can provide guidance and support to ensure that your medical device registration and filing processes run smoothly and successfully in China.
Stay informed and up-to-date with the latest regulatory changes to ensure the continued success of your medical device products in the Chinese market.