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Administration (TGA) – the national regulator for medical devices in Australia – is seeking public feedback on its draft guidance regarding the boundary between medical devices and similar products.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The draft guidance will update industry on the TGA's views in response to significant changes in the regulation of therapeutic goods.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.
The draft guidance starts by outlining definitions for medicines, medical devices, and biologicals, which are set out in Sections 3, 41BD and 32A of the Therapeutic Goods Act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 In defining these three terms, the TGA’s draft guidance adopts the definitions used by the EU’s MDCG in Guidance 2022-5 on Borderlines between Medical Devices and Medicinal Products.
The draft guidance goes on to discuss boundary products, i.e. those therapeutic products that have attributes that are characteristic of two or more categories of therapeutic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;
Finally, the draft guidance describes different types of combination products.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.
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:
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.)
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.
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