Background
Vaping devices can be supplied in Australia either by being included in the Australian Register of Therapeutic Goods (ARTG) or via the unapproved goods pathway. Sponsors of vaping devices have ongoing regulatory responsibilities to ensure their devices continue to comply with regulatory requirements and are safe to use.
We may send sponsors post-market compliance regulatory notices requiring information to be provided through the post-market review compliance portal. However, regulatory notices for devices not included in the ARTG cannot currently be sent or received via the portal. The proposed changes will amend the post market review compliance portal to allow sponsors of unapproved devices to receive and respond to regulatory notices.
The aim of the webinar is to provide an overview of the proposed amendments to the compliance portal and provide an opportunity to ask questions and provide feedback on the process of viewing and responding to regulatory notices.
Speaker
Amanda Craig, A/g Assistant Secretary Medical Devices Surveillance Branch, TGA
Webinar details
When: Friday 20 September 2024
Where: online
Time: 10:30 - 11:30am AEST
When: Friday 20 September 2024
Where: online
Time: 3:30 - 4:30pm AEST