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CMDE（醫療器材技術審評中心）

中國NMPA下屬的技術審評機構，負責評估醫療器材註冊申請。CMDE對II類和III類器材進行科學評估，類似於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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相關術語

上市許可持有人(MAH)