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Consultation: Draft Guidance: Boundary and Combination products - medicines, medical devices and biologicals

Consultation period:
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Last updated

This consultation closed on 20 November 2022.

We invited stakeholders to provide feedback on the draft guidance for ‘Boundary and combination products - medicines, medical devices, and biologicals’ to replace the existing guidance ‘Australian medical devices guidelines: 35. Device-medicine boundary products’. 

The consultation was open for feedback from Friday 7 October 2022 to Sunday 20 November 2022 through an online survey hosted on the TGA Consultation Hub. 

Outcome of the consultation

In total, 31 responses were received from stakeholders, including sponsors, manufacturers, peak industry bodies, regulatory affairs consultants, researchers, and health regulators. 

A summary of responses and individual responses in accordance with respondent’s consent has been published on the Consultation Hub

In response to the feedback provided, we have updated our guidance and example list on boundary and combination products. 

Next steps

We are undertaking another external consultation on proposal to legislate some boundary and combination products for additional clarity and transparency on the regulatory category. 

Enquiries 

For enquiries relating to the consultation or next steps, email devicereforms@tga.gov.au.