The CMDE published a revision of the supplement phase on February 20, 2023, suggesting that it is ending Covid measures on medical device registration.
The notice says that:
- For “medical device supplementary information notice” issued before February 20, 2023, the period for supplementing the information will be extended by one year (two years in total).
- For “medical device supplementary information notice” issued on and after February 20, 2023, the time limit for submitting supplementary materials will be restored to one year.
Guideline on Supplement Phase
The NMPA published the “Medical Device Submission Document Administrative Measures during the Supplement Phase” on January 16, 2020. Commonly known as “deficiency” by U.S. FDA, Supplement Phase provides NMPA an opportunity to request additional information on medical device marketing applications. The supplement phase is needed if the registration documents submitted by the applicant cannot meet the relevant regulations or technical standards.
The document, referring on FDA Guidance of Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provision, specifies the situations to initiate the supplement phase, suggested content and format for notification letters by NMPA, and suggested format for response letters and submission materials by manufacturers.
When to Submit Additional Documents
The Administrative Measures list five scenarios when Supplement Phase is initiated:
- Technical information on safety and effectiveness evaluation (e.g. physical and chemical properties, electrical safety, biological evaluation, clinical evaluation, etc.) are inadequate, incomplete or incorrect
- The relevant supporting documents or regulatory information are missing or do not meet the requirements
- Problems occurs with the textual specification or Chinese translation of the application materials
- The form, signature and special binding of the application materials are incompliant with regulations
- Other information required.
Takeaways for Manufacturers
The document specifies the number of different requests by NMPA and applicants:
- NMPA will only request additional information in ONE TIME
- Applicants shall submit additional documents in full in ONE TIME in ONE YEAR after receiving NNPA’s request
- Applicants can request online meetings with NMPA THREE TIMES in the given ONE YEAR
- Before the final submission, applicants can request Pre-Assessment from NMPA for ONE TIME.