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Borderline, Combination & SaMD

Borderline Products​

A product is borderline if it sits between a medical device and a pharmaceutical. The key question: what is the principal mechanism of action?

  • Mechanical/physical principal action → likely a medical device (MDACS)
  • Pharmacological/immunological/metabolic principal action → likely a pharmaceutical (Pharmacy and Poisons Ordinance)

If uncertain, consult the MDD for a product scope determination.

Combination Products​

Products combining a device and medicinal component are classified based on which component provides the primary intended purpose. The medicinal component must be documented and risk-assessed.

Software as a Medical Device (SaMD)​

SaMD is classified using standard TR-003 rules based on:

  • The clinical severity of the condition addressed
  • The significance of the software's output to clinical decisions

High-risk diagnostic AI (e.g., cancer detection) → typically Class III or IV. General clinical decision support → may be Class II. See SaMD Overview.