Dear Sponsors/ Stakeholders,
The TGA’s public consultation on proposed changes to the Australian medical device Essential Principles is now open.
In 2019, the TGA undertook a consultation on: proposed changes to the Australian (AUS) medical device Essential Principles (EPs) for safety and performance. Feedback on this consultation indicated strong support for alignment with the General Safety and Performance Requirements (GSPR) of the European Regulations.
This second consultation paper seeks to confirm views on, where appropriate, AUS EPs should align with the GSPR of the European Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 for in vitro diagnostic medical devices (IVDR). We invite you to provide your input on the consultation paper by answering a survey on the TGA Consultation Hub using this link: https://consultations.tga.gov.au/tga/aus-essential-principles-aligning-eu-regulation. Please read the consultation paper and attachment 1, and keep them available for reference when responding to the survey.
The consultation will close on 16 October 2024.
Webinars:
The TGA will be hosting webinars to briefly discuss the consultation paper and answer related questions on the below dates. Further information on these webinars and a registration link will be circulated shortly.
Webinar 1: Wednesday 11th September 2024 – 5pm-6pm
Webinar 2: Thursday 12th September 2024 -12pm – 1 pm
If you have any questions or concerns, please email us at devicereforms@tga.gov.au.
Kind regards
TGA Medical Device Reforms Projects Team