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

Closed 20 Nov 2022

Opened 7 Oct 2022

Feedback updated 8 Dec 2023

We asked

We asked your feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’ which will replace the existing guidance ‘Australian medical devices guidelines: 35. Device-medicine boundary products’.

The guidance aims to assist sponsors and manufacturers understand how TGA regulates boundary and combination products that may not fit clearly within existing definition of medicines, medical devices or biologicals.

You said

Thirty-one (31) responses were received from stakeholders, including sponsors, manufacturers, industry peak bodies, regulatory affairs consultants, transplant donation organisations, contract research companies and other health regulators.

Alignment of guidance with respondent’s understanding

Overall, a majority of respondents (55%, n=17) indicated that the draft guidance material aligns with their current understanding of medicines, medical devices, and biologicals.

Out of those respondents who disagreed (45%, n=14) on the alignment with their current understanding, most suggested examples that were not addressed in the draft guidance, and that there were products listed in Appendix 1 where:

  • further clarification of the product, category or mode of action is needed,
  • the rationale for the product category designation was not clear, or counter-intuitive, and
  • the product category is not in alignment with international jurisdictions.

Products that are not in alignment with the definitions

Some respondents (24%, n=13) indicated that there were products on the market that were not aligned with the definition and product category mentioned in the draft guidance for example:

  • products for lice on the head and body
  • products for removal of warts
  • corn and callus removal products
  • oral care toothpastes
  • products used to cleanse dentures
  • throat lozenges
  • sunscreens that work through creating a physical barrier (zinc oxide-based)
  • compounded and uncompounded emollient & moisturising preparations for therapeutic use
  • anticoagulation solution bags used during blood cell separation (apheresis)
  • carbon crucible required to make Technegas
  • alcohol swabs containing an active ingredient or medicine claiming use for cleaning skin only
  • non-antibiotic-based antimicrobial catheter lock solutions sold separately from a catheter
  • personal lubricants used during sexual activity
  • douches (e.g., douche applicator, solution, applicator-solution combined)

Interim arrangements for change of product category

Out of those who responded (n=29) to the question, majority (67%, n=12) suggested that special, interim arrangements would be required to ensure continued supply of products if the product category was changed whereas, six respondents (33%) suggested interim arrangements would not be required. Remaining stated that the question is not applicable to them.

In general, respondents advised that the timing of interim arrangements would depend on requirements from the TGA.

Respondents raised several issues and challenges regarding transitioning of products to new categories including:

  • manufacturers may not be able to provide the required regulatory evidence to support product inclusion under a new category,
  • transitioning products supplied as a medical device to a medicine will be difficult, as these products will now need to be manufactured according to GMP requirements, and
  • potential costs for industry might result in business decision to withdraw products from the Australian market.

There were several other suggestions provided by respondents to improve the draft guidance across the range of submissions. These included:

  • harmonising with international definitions for pharmacologic, physical and metabolic means
  • use of decision trees or tools to help sponsors decide product categories
  • adding guidance on regulatory evidence required for combination products
  • adding more:
    • information on boundaries between medicines, food and cosmetics, 
    • information explaining how TGA regulates and categorises boundary and combination products and the rationale for regulatory decisions,
    • information on regulation of biologicals and biological combination products,
    • information on excluded goods, kits that contains medicines and biologicals,
    • adding links to TGA guidance on reclassification of medical devices, and
    • examples of each of the categories.

There were suggestions to improve the list of boundary products indicating product categories in Appendix 1 of the draft guidance. These included:

  • suggested changes to the list, clarifying or adding products and their categories,
  • adding an additional column to the list that explains the rationale for why products are categorised as a medicine, medical device, biological or another product category,
  • harmonisation with international jurisdictions where appropriate, with any differences clearly communicated,
  • advising sponsors if there is any action required to accommodate the updated guidance,
  • clarifying boundary and combination products by making greater use of powers under the Therapeutic Goods Act 1989 (the Act) to specify particular goods to be medical devices and to declare that a particular class of goods to not be medical devices.

We did

In response to your feedback, we revised and published updated guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’ with several changes including:

  • more information and examples on regulation of boundary and combination products,
  • explanation on how TGA regulates and categorises boundary and combination products,
  • links to additional TGA guidance that may help you decide your product category,
  • TGA contacts for sponsors and manufacturers who are unsure about the category and regulation of their boundary and combination products,
  • improving readability by moving detailed background information on the definitions of medicine, medical device and biologicals and differentiating terms to the end of the document into an Appendix.

We acknowledge your feedback on the list of boundary products indicating the category of therapeutic good in Appendix 1. In response, we removed the list of boundary products (Appendix 1) from the guidance to enable us to publish the updated guidance while we continue to address your feedback on the list. 

What is next

We are finalising an updated list of boundary and combination products (formerly Appendix 1 in the draft guidance) based on your feedback. We will notify you once the updated list is published on our website.

We are currently considering further targeted consultation on the list of boundary and combination products (formerly Appendix 1) to address your feedback and whether the updated list (formerly appendix 1) is sufficient to provide regulatory certainty, or if legislative changes would be required.

If legislative changes are proposed, the TGA will consult with stakeholders and consider transitional arrangements for potentially impacted stakeholders. We will continue to engage with you around any further changes.

Published responses

View submitted responses where consent has been given to publish the response.


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