Skip to content

Australian TGA consults on draft borderlines guidance

Published by Alec Denniff, Medical Device Paralegal on

The Therapeutic Goods Administration (TGA) – the national regulator for medical devices in Australia – is seeking public feedback on its draft guidance regarding the boundary between medical devices and similar products. The consultation period on the draft, titled "Boundary and combination products, concerning medicines, medical devices and biologicals", will close on 20 November 2022.

The guidance addresses the regulatory status of therapeutic goods (an umbrella term used by the TGA that includes medicines, biologicals and medical devices) that do not fit clearly within existing definitions, including combination products. It aims to provide clarity on which regulatory pathway is appropriate for these products. 

The draft guidance will update industry on the TGA's views in response to significant changes in the regulation of therapeutic goods. As noted by TGA, its existing guidance on the topic dates back to 2005 and only dealt with the medical device-medicine boundary. The regulatory framework for biologicals was introduced in 2011 to cover human tissue, cell-derived products and live animal cells, tissues or organs. The guidance therefore required updating to address possible confusion between devices, medicines and biologicals.

Key definitions and approach

The draft guidance starts by outlining definitions for medicines, medical devices, and biologicals, which are set out in Sections 3, 41BD and 32A of the Therapeutic Goods Act 1989 respectively. The guidance then goes on to outline the key differences between these groups of products. In particular, in determining if a product is expressly excluded from the definition of a medical device, TGA notes that it is necessary to consider whether the principal intended action (i.e. the main mechanism of how the product exerts its therapeutic effect) of the product is by pharmacological, immunological or chemical means. In defining these three terms, the TGA’s draft guidance adopts the definitions used by the EU’s MDCG in Guidance 2022-5 on Borderlines between Medical Devices and Medicinal Products.

The draft guidance goes on to discuss boundary products, i.e. those therapeutic products that have attributes that are characteristic of two or more categories of therapeutic goods, and those for which the appropriate regulatory pathway is not immediately obvious. In deciding how such products are regulated, TGA notes that it will consider;

  • Which component or ingredient of the product provides the most important therapeutic effect of the product; 
  • The principal therapeutic effect achieved by the product when used consistently with the intended use provided by the manufacturer’s claims, and;
  • The primary mode of action of the product in achieving its therapeutic effect, and how this relates to the definitions of medicines, medical devices and biologicals. 

Finally, the draft guidance describes different types of combination products. There is also a list of examples in Appendix I, indicating the regulatory framework that is likely to apply to each of the products listed.

Medicine-device interface

Noting the interface between medicines and devices, including those devices that incorporate, or are used to administer a medicine, TGA observes three types of medicine-device combination products, and how these should be regulated depending on the primary intended purpose of the product:

  1. Medical devices that are used to administer a medicine (e.g. medicine spoons, droppers, syringes marketed empty). If supplied separately, such products are regulated as medical devices. If medicine measures are co-packaged with, or contained within the same pack as the medicine, and where the device is to be used to measure or administer the medicine in the pack, the entire product is regulated as a medicine (e.g. a paracetamol oral liquid and an accompanying measuring syringe.) 

  2. Medical devices for administering medicines, where the medicine and device form a single integral product, designed to be used exclusively in a given combination, which is not re-usable or refillable (e.g. a syringe marketed pre-filled with a medicine). Such products are specifically excluding from being regulated as medical devices because they are listed in the Therapeutic Goods (Articles that are not Medical Devices) Order No.1 of 2010. These products are regulated as medicines, and the relevant essential principles in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 are additionally applied to the safety and performance features of the device. This approach is identical to that used by the EU, as determined by Article 1 (9) EU MDR.

  3. Devices which incorporate, as an integral part, a substance that, if used separately, would be considered a medicine, and this substance is liable to act upon the body with action ancillary to that of the device (e.g. a heparin coated catheter.). Such products are regulated as medical devices but the safety, quality and usefulness of the medicinal substance must be verified by TGA’s Medicines Regulation Division. Again, this approach is identical to that used by the EU, as determined by Article 1 (8) EU MDR.

Biological-device interface

At the biological-device combination level, TGA advises that biologicals which are presented as a combination product because they have a medical device component (such as a metal stent which is coated with a matrix and endothelial cells), will be subject to regulation as biologicals under the Biologicals Regulatory Framework. This would be supplemented by an additional assessment of the device components under the medical device regulatory requirements. The combination product would also be included in the Australian Register of Therapeutic Goods (ARTG) as biologicals. (The device component would not separately appear in the ARTG.)

Biological-medicine interface

The TGA has taken the same approach at the biological-medicine interface, determining that the biological framework would take precedence. This means that biologicals presented as combination products with a medicine component are regulated under the Biologicals Regulatory Framework. 


Those interested in expressing their views on the draft guidance may do so until 20th November 2022.

The Regtik platform provides an AI-powered guide through the regulatory maze, including up-to-date consideration of guidance from regulatory bodies such as the TGA. You will be able to determine your product’s regulatory status and assess available regulatory pathways with step-by-step requirements for those pathways. The Regtik assessment provides a fully reasoned report detailing how and why your product will be regulated. We can take you from a state of confusion to a place of clarity and confidence on your next regulatory steps. If you are interested in learning more about Regtik or would like a demo, please contact any member of the team or register your interest below.