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Priority Review (优先审批)

NMPA operates a Priority Review (优先审批) programme that provides expedited technical review for medical devices meeting specified criteria. The programme is designed to accelerate market access for innovative and high-need devices.

Eligibility criteria​

Priority review is available for devices that:

  1. Treat or diagnose rare diseases with no currently available or adequate existing treatment in China
  2. Address paediatric needs where no suitable device for children is available
  3. Are truly innovative — first-in-class technology with significant clinical advantage
  4. Are urgently needed in emergency situations
  5. Have been granted priority or expedited access by a recognised overseas reference authority (FDA Breakthrough, EU MDR Art. 59, etc.)

Application process​

  1. Applicant submits a priority review designation request (优先审批申请) to NMPA/CMDE before formal registration dossier submission, including detailed justification documenting how the device meets one or more eligibility criteria; request should cite relevant NMDCC classification and clinical evidence
  2. CMDE evaluates the request (typically 20 working days)
  3. If granted, the device is placed on a priority list and reviewed with shortened CMDE review timelines
  4. Priority status must be maintained — the applicant must continue to meet responsiveness requirements

Benefits​

Standard reviewPriority review
Up to 90 working days technical reviewUp to 60 working days
Multiple supplemental rounds may occurCMDE may provide pre-submission guidance
Standard NMPA processing timeExpedited administrative processing

Priority review does not reduce the evidence requirements — the same safety, performance, and clinical evidence standards apply. Instead, it reduces administrative processing time. Some major deficiencies identified during review may cause loss of priority status.

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.