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What Is a Medical Device?

Under MDACS, a medical device is any instrument, apparatus, appliance, software, material, or other article — used alone or in combination — intended by the manufacturer to be used in or on humans for:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment or compensation for an injury or handicap
  • Investigation, replacement or modification of anatomy or a physiological process
  • Control of conception

The principal action must not be pharmacological, immunological, or metabolic — that distinction separates devices from medicines.

Software as a Medical Device (SaMD)​

Software with a medical intended purpose is captured within the device definition, consistent with IMDRF SaMD guidance. See SaMD Overview.

IMDRF Alignment​

Hong Kong's MDACS adopts IMDRF principles for definitions and classification, ensuring close alignment with Singapore, Australia, Canada, and other IMDRF members.

Next step

Once you confirm your product is a medical device, determine its risk class. See How Classification Works.