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

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 will be in effect from 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 consulted on proposals to further refine the regulations for medical devices fitting the above description.

We hoped feedback on the proposed amendment would help us identify any issues that may arise if the Therapeutic Goods Regulations are changed as well as enable us to tailor our stakeholder education program in relation to these products.

For more information on the consultation, including its outcomes, visit our consultation hub - external site.

Consultation documents

• 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 (pdf,248kb)
• 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 (docx,100kb)