Feedback sought on proposed changes to medical devices that are substances


AusBiotech is seeking feedback from members that may be impacted by proposed TGA regulation changes through the Proposed refinements to the regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin.

The TGA is committed to aligning Australian medical device regulations with the EU framework – where possible and appropriate. The AusBiotech AusMedtech Regulatory Affairs Advisory Group is considering responding to the consultation and seeks to better understand how this proposed rule deviation will affect AusBiotech members, given the overlap in the medicine and medical device regulatory frameworks for some products.

Following a public consultation, the TGA amended the regulations for medical devices by introducing new classification rules for medical devices that are substances intended to go into the human body through an orifice or be applied to the skin, and are absorbed or dispersed. The new rules take effect on 25 November 2021. This consultation seeks to further refine this regulation.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Members are invited to read the consultation paper here and to contact AusBiotech’s Director, Industry Policy and Advocacy, Khaled Chakli, with your feedback by 2 August 2021.