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.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.