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NMPA Class II Path

NMPA Path

Regulatory filing and registration path for digital pulse hardware and doctor-assistive AI.

Product classification & framing

Pulse capture hardware is classified per the NMPA medical-device catalogue and proceeds through type testing, clinical evaluation and registration / filing.

Doctor-assistive AI software follows the "Medical Device Software / AI medical software" path with a clearly stated "doctor-assistive" intended use — explicitly avoiding "auto-diagnosis / auto-prescription" framing.

Milestones

  • 01
    Project initiation
    Define intended use, risk control and clinical evaluation path.
  • 02
    Type testing
    Type-test reports completed at designated institutions.
  • 03
    Registration filing
    Submit registration to NMPA per classification.
  • 04
    Post-market supervision
    Adverse-event monitoring, version-change management, continuous compliance.