Photographer: Hitesh Choudhary

Overview:

On January 16, 2020, NMPA published the final guideline on “Medical Device Submission Document, Administrative Measures during the Supplement Phase”. This guideline explains how medical device manufacturers should respond to a letter of deficiency from NPMA.

MAIN REASONS FOR RECEIVING A LETTER OF DEFICIENCY FROM THE NMPA:

  1. Inadequate, incomplete or incorrect technical information on safety and effectiveness of the medical device evaluation.
  2. Missing supporting documents or regulatory information.
  3. Issues with translated documents in Chinese.
  4. Administrative issues: using incorrect application form, missing a signature or using the incorrect binder.

HIGHLIGHTS OF NMPA GUIDELINE ON SUPPLEMENTS

  1. NMPA will only send one [1] request for additional information 
  2. Applicants shall submit all additional documents once and within one [1] year of the request. 
  3. Applicants can request up to three [3]  face-to-face meeting with NMPA in the  given one [1] year.
  4. Before the final submission, applicants can request one [1] Pre-Assessment  of the response from NMPA.

RESPONDING TO A LETTER OF DEFICIENCIES: (SUPPLEMENT SUBMISSIONS)

Since the implementation of NMPA electronic Regulated Product Submission (eRPS) system on June 24, 2019, applicants can review deficiency letters on line and submit their responses online as well. Applicant can still submit Paper-based responses for now if desired.

MORE RESOURCES:

China’s NMPA

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