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Consultation: 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

19 July 2021

We have changed the way to make submissions.

Submissions now should be provided through our consultation hub.

This consultation closed on 13 August 2021.

The TGA proposes refinements to the regulation of medical devices that are substances introduced into the human body via an orifice or applied to the skin

In December 2019 an amendment to the regulations for medical devices introduced 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 amendment followed a public consultation process conducted by the Therapeutic Goods Administration (TGA) in early 2019.

Based on feedback from consumers, healthcare professionals, hospitals and medical device companies, we are now consulting on proposals to further refine the regulations for medical devices fitting the above description.

Feedback on this proposed amendment will help us identify any issues that may arise if the Therapeutic Goods Regulations are changed. Feedback will also enable us to tailor our stakeholder education program in relation to these products.

Consultation documents

We aim to provide documents in an accessible format. If you're having problems using this document, please contact devicereforms@tga.gov.au.