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Background
Vaping devices and accessories can be supplied as unapproved medical devices, that is, they are not included in the Australian Register of Therapeutic Goods (ARTG). Vaping devices must comply with either the Essential Principles or Therapeutic Goods (Medical Device Standard - Therapeutic Vaping Devices) Order 2023 (MDSO) before being lawfully supplied in Australia.
We may, in exceptional circumstances, grant consent to import, supply or export vaping devices that do not comply with the Essential Principles. Consent to supply, import, export, or supply applications are submitted via the post-market sponsor portal. However, applications for devices not included in the ARTG cannot currently be submitted via the portal. The proposed changes aim to amend the application form for use by sponsors of unapproved devices.
The aim of the webinar is to provide an overview of the proposed amendments to the sponsor portal and provide an opportunity for sponsors to ask questions and provide feedback on the application process.
Speaker
Amanda Craig, A/g Assistant Secretary Medical Devices Surveillance Branch, TGA
Webinar details
When: Wednesday 18 September 2024
Where: online
Time: 10:30 - 11:30am AEST
When: Wednesday 18 September 2024
Where: online
Time: 3:30 - 4:30pm AEST