Consultation on Medical Devices – AUS Essential Principles – Part 2: Alignment with the EU General Safety and Performance Requirements
The above consultation is currently open on the TGA Consultation Hub until 16 October 2024.
The TGA Medical Device Reforms Project Teams are holding two webinars for stakeholders to raise any questions or topics related to the proposals in the Essential Principles consultation. There will be a short presentation followed by a panel discussion which will initially focus on addressing any pre-submitted questions. If time permits there will be an opportunity to ask additional questions.
Register for webinar session:
The presentation and discussion on pre-submitted questions will be the same in both sessions.
Please select your preferred session time and register through the link on the webpage:
Pre-submit questions/topics for discussion:
We strongly encourage you to send through your questions or specific topics you would like our panel to discuss. This will help us to provide the appropriate technical expertise and efficiently address as many questions as possible in the time available.
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You may submit a question or topic when completing the registration for the webinar in the “pre-webinar questions” field, however there is a 900-character limit.
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If you cannot fit your question in the registration form “pre-webinar question” field, please send through your questions to: devicereforms@tga.gov.au by COB Friday 6 September 2024.
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For any questions submitted after 6 September 2024, these may or may not be included in the webinar, depending on time.
If you have any questions or concerns, please email devicereforms@tga.gov.au.
