The Therapeutic Goods Administration (TGA) is looking for public comment from the industry to
help them refine the regulations for certain types of medical devices such as IPLs and Lasers
before they change on 25th November 2021.


Please note that your opportunity to comment will close on 13th August 2021.

This new public consultation process is about substances that are made to go onto the skin,
or inside the body through an orifice, and are absorbed or dispersed. A new classification rule for these devices will take effect on 25 November 2021, due to an amendment to Australia’s medical device regulations that became law in December 2019.


Those changes followed a public consultation process conducted by the TGA in early 2019.
The TGA believes the rules may need further refinement after listening to consumers,
healthcare professionals, hospitals, and medical device companies, so, they have decided to
open up for another public consultation.


The new classification rule could mean that some of these products – substances that are
made to go on the skin, or inside the body through an orifice, and are absorbed or dispersed
– fit the definition of medicine as well as a medical device. Their proposed refinements
address this.


Find more information in our consultation paper and make a submission on the Department
of Health’s Consultation Hub: https://consultations.health.gov.au/tga/proposed-refinements-to-the-regulation-of-medical/

This consultation closes on 13 August 2021.
If you have any questions, please email devicereforms@health.gov.au.
Kind regards,
TGA Medical Devices & Product Quality Division

Give your comment here: https://consultations.health.gov.au/tga/proposed-refinements-to-the-regulation-of-medical/consultation/subpage.2021-06-08.2354496080/