March 23rd – 27th 2026
Inform Items
- The TGA is developing automated email status updates for Level 2 Application Audits. These are in the final stages of testing and development, and they aim to go into production within the next 2 months.
- The Post Market Review (PMR) compliance portal has been updated to allow sponsors of medical devices exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG), such as therapeutic vaping devices and device accessories, as well as medical devices included in the ARTG, to view and respond to notifications. Please refer to Post market review compliance dashboard | Therapeutic Goods Administration (TGA) for guidance on how to view or respond notifications relating to post market reviews of medical devices.
- The TGA continues to monitor disruptions or impacts to the supply of medical devices to Australia. If you are aware of emerging disruptions or impacts from recent developments, you are welcome to communicate with them via MD.SupplyDisruptions@health.gov.au Clear and measured communication with customers can help support responsible purchasing and ongoing availability. They are progressing and will provide a separate update for further information about TGA’s various pathways to facilitate and support emerging supply disruptions.
Action Items
- Conformity Assessment Procedures – our draft response has been uploaded onto the forum groups on RegConnect, and has been attached here for your reference. Please comment any feedback you may have by April 1st. If you hadn’t received the notification from the site for the same, please reach out to lwaheed@mtaa.org.au
