How to Interact with NMPA for Your Innovative & Priority Device? Guideline Issued

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The NMPA released the “Communication Standards for Innovation Approval and Priority Review” on December 1, effective from the date of publication. The standards are to direct manufacturers on what to expect for CMDE (center for medical device evaluation) responses and how to communicate with reviewers.

Highlights from the Standards

  1. Reviewers will initiate first meeting in 10 days after the device is granted Innovative Device Status.
  2. The discussion in the first meeting shall include:
    • Progress in product development
    • Major technical problems encountered by the applicant at this stage
    • Applicant’s application timeline and arrangement
    • Work plan of the next meeting and the tasks of both parties
  3. Review department and clinical department will keep the notice of each meeting.
  4. CMDE will discuss with applicant 1 time each year as least
  5. Applicant shall appoint one RA personnel as representative
  6. CMDE will establish a platform online “Medical Device Technology Review Consulting-Innovation & Priority Communication”
  7. For general questions, communication by phone call and email is available
  8. The follow-up meeting will be held under the circumstances below:
    • Major technical issues
    • Major safety issues
    • Clinical trial plan
    • Summary and evaluation of clinical trial results
    • Supplementary materials
    • Other important issues
  9. The project manager of the evaluation department or clinical department shall notify the applicant within 3 working days after the meeting request is approved.
  10. Meetings shall be held within 20 working days after the request is approved
  11. The project manager shall send the meeting minutes to the applicant within 20 working days after the meeting, which will be saved for future reference.

The standards also address the issues involving the expert panel on priority review. For more information, please email info@ChinaMedDevice.com.