Skip to main content

Technical Review Process

For Class III and imported medical devices, the Centre for Medical Device Evaluation (CMDE) conducts the technical review of the registration dossier. Understanding the CMDE process helps applicants anticipate timelines and prepare effective responses.

CMDE review stages​

Application submitted to NMPA
    │
    ▼
NMPA completeness check (5 working days)
    │  If incomplete → rejection with written reasons
    ▼
CMDE technical review assigned
    │  (up to 60 working days, extendable for complex devices)
    ▼
Supplemental information request (if required)
    │  Applicant has up to 3 months to respond
    │  CMDE has 30–60 working days to review response
    ▼
Expert consultation (if required)
    │  CMDE may convene an expert panel for novel technologies
    ▼
CMDE technical review opinion issued
    │  Positive: recommend approval
    │  Negative: recommend rejection (with reasons)
    ▼
NMPA administrative decision
    │  (20 working days)
    ▼
Registration certificate issued (or rejection)

Common causes of supplemental information requests​

  • Incomplete biocompatibility testing (missing ISO 10993 endpoints)
  • Clinical evaluation not meeting NMPA clinical data requirements
  • Insufficient shelf-life / stability data
  • Labelling errors (missing Chinese mandatory elements)
  • Software documentation incomplete (for SaMD)
  • Sterility validation incomplete

Responding to supplemental requests​

A well-organised, point-by-point response to each deficiency significantly reduces the risk of a second supplemental request. NMPA/CMDE guidance on common deficiencies is published on the CMDE website.

Appeal (复审)​

If NMPA issues a rejection decision, the applicant may request a technical re-review (复审) within 60 days of receiving the rejection. The re-review is conducted by a different CMDE reviewer. If the re-review upholds the rejection, the applicant may pursue administrative reconsideration (行政复议) or administrative litigation.

Disclaimer

Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.