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CATEGORY: ORGANIZATIONS

CMDE (Center for Medical Device Evaluation)

China's technical review body under NMPA responsible for evaluating medical device registration applications. CMDE conducts scientific assessments of Class II and III devices, similar to FDA's CDRH.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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.

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SOURCES

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RELATED TERMS

Marketing Authorization Holder (MAH)