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CMDE（医疗器械技术审评中心）

中国NMPA下属的技术审评机构，负责评估医疗器械注册申请。CMDE对II类和III类器械进行科学评估，类似于FDA的CDRH。

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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相关术语

上市许可持有人(MAH)