27 October 2022

Draft Guidance on boundary and combination products published by TGA



On 08th of October 2022, the Australian Therapeutic Goods Administration (TGA), published the draft guidance Boundary and combination products – medicines, medical devices, and biologicals and is open for comments until 20th of November, 2022.


These Guide is to assist sponsors and manufacturers in determining the most appropriate regulatory pathway for a product and the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices. In developing the list, the status of each product in the US and the European Union was considered with the desire that distinctions recognised in those jurisdictions be adopted where consistent with the Therapeutic Goods Act 1989.


Under the Therapeutic Goods Act 1989, therapeutic goods are regulated as medicines, biologicals, medical devices, or other therapeutic goods. However, in some cases, determining which therapeutic goods definition applies to a product and the appropriate regulatory pathway can be complex. There are some products that may appear to fall within more than one definition and require further analysis to determine which therapeutic goods definition applies, these are often referred to as boundary products. The guidance sets out, in broad terms, principles to assist in determining which requirements within the Australian regulatory framework may apply to a certain product and lists some examples of these boundary products. Within medical devices there are also other borderlines (for example with cosmetics, personal protective equipment, biocides etc). However, the document relates specifically to the differentiation between medical devices, medicines, and biologicals. The list of products within Appendix 1 includes guidance on the regulatory framework likely to apply to such products. In the case of products containing both medicine and device components, the TGA will evaluate both components even if the product overall is regulated as a medical device or medicine.


Guidance also sets out the definition and explanation on combination products (medicine – medical device and biological – medical device combinations); medical devices that incorporate, or are used to administer, a medicine / biological are regulated as either medical devices or as medicinal products, depending on the primary intended purpose of the product. The document defines three types of medicine-device combinations:

  • devices that are used to administer a medicine;
  • devices for administering medicines where the device and the medicine form a single integral product designed to be used exclusively in the given combination and that are not re‐usable or refillable;
  • devices incorporating, as an integral part, a substance, that, if used separately, may be considered to be a medicine and where the substance is liable to act upon the body with action ancillary to that of the device.

There is a specific guidance available for medicine devices combinations covered by system or procedure packs; System or procedure packs (November 2021).