Boundary and combination products guidance - medicines, medical devices, and biologicals

Closed 20 Nov 2022

Opened 7 Oct 2022


The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals

The purpose of this draft guidance is to assist sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices. The draft guidance aims to provide clarity on which regulatory pathway is appropriate for therapeutic goods. In developing the list at Appendix 1, 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 (the Act).

This draft guidance is intended to replace the existing guidance on boundary products, ‘Australian medical devices guidelines: 35. Device-medicine boundary products’, dated November 2005, which is available on the TGA website or downloadable via a link at the bottom of this page. The existing guidance is out of date and requires updating to reflect significant changes in the regulation of therapeutic goods since 2005, including the introduction of the biological regulatory framework and new requirements needed to appropriately regulate emerging types of products continually entering the market.

Why your views matter

This consultation process is your opportunity to contribute to helping the TGA deliver guidance that strengthens Australia’s regulatory framework for all therapeutic goods, ensuring they are regulated under the scheme most appropriate to their effects on the human body and the risks they might pose, by providing clarity, removing sources of ambiguity. The perspectives and experiences of all stakeholders are valued and will be important in informing the draft guidance.

In this consultation, we are seeking your views on the following questions:

  • Does the draft guidance align with your understanding of what medicines, medical devices and biologicals are?

  • Are you aware of currently marketed products that are not in alignment with the definitions in this draft guidance, and if so, what are they?

  • Are special, interim arrangements required to ensure continued supply of products that have to date been represented and sold as a type of therapeutic good inconsistent with this guidance?

  • Are there any other issues that should be addressed in the draft guidance?

For further background and information, please refer to the draft guidance 'Boundary and combination products - medicines, medical devices, and biologicals', downloadable via a link at the bottom of this page

We invite you to complete our online survey (click on the link below)

If you prefer, you can make a submission directly to the Department via post or email at the following addresses:

Advanced Biological Therapies Section
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please make any proposed amendments using tracked changes. Please also download and complete a copy of the Cover Sheet. Both are available via links at the bottom of this page.

What happens next

Feedback collated during this consultation process will inform the draft guidance.


  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Local governments
  • Health professionals
  • Health workforce
  • Community groups
  • Businesses
  • HPRG (TGA) Staff
  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Medical Devices & IVDs
  • Biologicals


  • Legislation
  • Regulatory policy