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Devices Incorporating a Medicine

Overview​

Some medical devices incorporate a medicinal substance as an integral part of their design — for example, antibiotic-coated catheters, drug-eluting stents, and bone cement containing antibiotics. These combination products sit at the boundary between medical device and medicine regulation and require careful determination of the primary mode of action to establish the correct regulatory pathway.

Primary Mode of Action​

The key question is whether the product's principal intended action is achieved by the device component or the medicinal component:

  • Device is primary: If the medicinal component plays an ancillary role to the device's primary mechanical or physical function, the product is regulated as a medical device incorporating a medicine. The device must comply with the Essential Principles, and the medicine component must be assessed for quality, safety, and performance.
  • Medicine is primary: If the principal action is pharmacological, immunological, or metabolic, the product is regulated as a medicine, not a device.

Classification​

A device incorporating a medicine is generally classified as Class III under Rule 5.1 of Schedule 2, regardless of what class the device would otherwise be. This reflects the higher risk of combining device and medicinal actions.

The TGA's Boundary and Combination Products Guidance​

The TGA has published guidance specifically addressing the boundaries between medicines, biologicals, and medical devices, and how combination products are regulated:

👉 Boundary and combination products — TGA

Conformity Assessment​

For devices incorporating a medicine, the manufacturer must demonstrate compliance with the Essential Principles for both the device component and the medicinal component. This typically requires:

  • Device testing per relevant IEC/ISO standards
  • Pharmaceutical assessment of the medicinal component (stability, compatibility, drug release)
  • Biocompatibility assessment
  • Clinical evidence for the combined product

Official Sources​