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    National Medical Products Administration

    China's regulatory authority for drugs, medical devices, and cosmetics.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    NMPA (formerly CFDA) regulates the registration, manufacture, import, and post-market surveillance of medical devices in mainland China through a three-class risk-based framework.

    What this means in practice

    Most Class II and III devices require in-country clinical evaluation or trials, type testing at NMPA-designated labs, and a local agent. Recent reforms have introduced an innovative-device fast track and accept some overseas data.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    NMPA·1FDA·1European Commission·1
    1. 1
      NMPA English portal
      Verified
      NMPAenglish.nmpa.gov.cn
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.