Class III Registration
Class III medical devices β those presenting the highest risk, or which are implantable or life-sustaining β are registered with national NMPA. Technical review is conducted by CMDE (Centre for Medical Device Evaluation).
Who regulates Class IIIβ
- NMPA: administrative authority β accepts applications, issues certificates, makes final registration decisions
- CMDE: technical review body β evaluates the safety and performance data in the dossier, requests supplemental information, and issues a technical review opinion
Registration dossierβ
See Dossier Requirements for the full list. Class III dossiers require comprehensive evidence across all technical domains.
Review timeline (indicative)β
| Stage | Working days |
|---|---|
| Completeness review (NMPA) | 5 days |
| Technical review (CMDE) | 60β90 days (extendable) |
| Supplemental information response period | Up to 3 months (applicant) |
| Post-supplemental review | 30β60 days |
| Administrative decision | 20 days after positive review |
Total elapsed time (good dossier, no supplementals): approximately 12β18 months. Complex devices or multiple supplemental rounds: 18β24+ months.
Pre-approval GMP inspectionβ
For domestic Class III manufacturers, a pre-approval GMP inspection by NMPA is conducted before the registration certificate is issued. The certificate is not issued until the inspection is passed. See NMPA GMP Inspections.
Supplemental information requests (θ‘₯ε θ΅ζιη₯)β
CMDE may issue one or more supplemental information requests during review. Each request pauses the review clock. The applicant has up to 3 months per request to respond. Failure to respond within 3 months results in withdrawal of the application.
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.