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CATÉGORIE: ORGANIZATIONS
CMDE (Centre d'évaluation des dispositifs médicaux)
L'organisme chinois d'évaluation technique sous la NMPA responsable de l'évaluation des demandes d'enregistrement.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
CMDE (Center for Medical Device Evaluation) is NMPA’s technical review center for medical device registration dossiers in China.
PROCESS / STEPS
- Prepare Chinese technical dossier aligned to CMDE expectations.
- Complete required testing at recognized labs.
- Respond to CMDE questions during review.
- Coordinate with the Chinese MAH on commitments.
EXAMPLES
- Class III innovative devices face the most intensive CMDE technical review.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to CMDE (Centre d'évaluation des dispositifs médicaux) across 27 authorities in real time.
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