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CMDE (Center for Medical Device Evaluation)

Chinas technische Prüfbehörde unter der NMPA für die Bewertung von Registrierungsanträgen für Medizinprodukte.

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

  1. Prepare Chinese technical dossier aligned to CMDE expectations.
  2. Complete required testing at recognized labs.
  3. Respond to CMDE questions during review.
  4. Coordinate with the Chinese MAH on commitments.

EXAMPLES

  • Class III innovative devices face the most intensive CMDE technical review.

RELATED GUIDES & TOOLS

SOURCES

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VERWANDTE BEGRIFFE

Zulassungsinhaber (MAH)