Building on the recent update to the "Guidance on Boundary and Combination Products" in December 2023, the Therapeutic Goods Administration (TGA) of Australia has released a complementary document titled "Examples of Boundary and Combination Products and their Product Category." This new resource is designed to assist manufacturers and sponsors in navigating the classification of products that straddle the line between medicines, medical devices, and biologicals.

By providing a clear list of common boundary products and their corresponding TGA classifications, the document aims to streamline the process of determining the appropriate regulatory pathway for these complex goods.

Some notable products include:

  • Absorbable implants (Collagen injections, Hyaluronic acid injections);
  • Contact lens care products;
  • Diagnostic imaging or similar agents (Laser fluorescent dyes, Tracers);
  • Hemostatic agents;
  • Multi-component packs (Kits containing medicine, System or procedure packs (SOPPs));
  • Products used to cleanse dentures such as dental cleansing solutions and brushes for cleaning dentures;
  • Products incorporating both a medicine and a medical device;
  • Drug-eluting stents;

The TGA acknowledges this list is not exhaustive and will be updated to include further products and clarifications as needed. Discussions are currently underway regarding the regulation of head and body lice products, moisturizers and emollients, and toothpastes. The document will be revised to reflect these decisions once finalized.

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Guidance on boundary and combination products

Examples of Boundary and Combination Products