China opened up again in 2023 and lifted travel restrictions associated with Covid since December 2022. Now NMPA released a revision notice of supplement phase on February 20, 2023, ending the 2nd year grace period for submitting deficiency documents. Now manufacturers must complete all its deficiency requirements and submit within 1 year from its initial deficiency notice date. This change has significant implications for device/IVD companies who are asked to do long term tests such as subchronic toxicity (not often) as well as new clinical trial requirements. Plan ahead and be more thorough during the initial submission becomes more important with this notice change.
The notice states:
- 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 resumed to one year.
Guideline on Supplement Phase
The NMPA released the "Medical Device Submission Dossier Administrative Measures during the Supplement Phase" on January 16, 2020. Commonly known as "deficiency" by U.S. FDA. During the Supplement Phase, NMPA requests manufacturers to address the deficiencies in the initial registration dossiers.
The Measures, referring to FDA Guidance of "Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions", specifies the situations to initiate the Supplement Phase, suggests content and format in notification letters by NMPA, and format in response letters and submission materials by manufacturers.
When to Submit Additional Dossiers
The Administrative Measures list five scenarios when Supplement Phase is initiated:
- Safety and efficacy evaluation of technical information (e.g. physical and chemical properties, electrical safety, biological evaluation, clinical evaluation, etc.) are not scientific, inadequate
- The relevant supporting dossiers or regulatory information do not meet NMPA requirements
- Problems of content expression, text standard or Chinese translation occur in materials for the registration submission
- The format, signature, stamp, and special binding of the application materials are incompliant with NMPA regulations
- Other information required for further supplement and revision.
Takeaways for Manufacturers
The Notice specifies the different requests by NMPA and applicants:
- NMPA will only issue ONE TIME request for additional information
- After receiving NMPA's request, applicants shall submit additional documents for completeness in ONE TIME within A YEAR
- Applicants can request online consultation meetings with NMPA THREE TIMES in the given ONE YEAR
- Before the final submission, applicants can request ONE TIME Pre-Assessment from NMPA.
Love to hear any challenges or questions you may have during supplement phase for NMPA registration submission. Please let me know if you have any particular concerns with this notice.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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