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:
- Treat or diagnose rare diseases with no currently available or adequate existing treatment in China
- Address paediatric needs where no suitable device for children is available
- Are truly innovative — first-in-class technology with significant clinical advantage
- Are urgently needed in emergency situations
- Have been granted priority or expedited access by a recognised overseas reference authority (FDA Breakthrough, EU MDR Art. 59, etc.)
Application process
- Applicant submits a priority review designation request (优先审批申请) to NMPA/CMDE, including a justification for eligibility
- CMDE evaluates the request (typically 20 working days)
- If granted, the device is placed on a priority list and reviewed with shortened CMDE review timelines
- Priority status must be maintained — the applicant must continue to meet responsiveness requirements
Benefits
| Standard review | Priority review |
|---|---|
| Up to 90 working days technical review | Up to 60 working days |
| Multiple supplemental rounds may occur | CMDE may provide pre-submission guidance |
| Standard NMPA processing time | Expedited administrative processing |
Priority review does not reduce the evidence requirements — the same safety and performance data is required.
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.