March 30th – April 2nd 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 TGA has published its position on UDI consent to supply. Sponsors will be able to use a streamlined process, with corresponding fees, for applications submitted on or after 1 July 2026. (noting that there will be NO refund provision if payment is made before 1 July 2026). Read more on the TGA website.
-
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 will provide an update about TGA’s various pathways to facilitate and support emerging supply disruptions at the meeting scheduled on Friday 10 April 2026.
- The Department of Health, Disability and Ageing has released the Health Provider Compliance Priorities for 2026 on 25 March 2026, that can be viewed by clicking on the link. The TGA has asked to share these Health Provider Compliance Priorities with relevant members within your organisation. If you have any questions regarding this publication, please feel to email regulatoryCompliance@health.gov.au.
-
The TGA released guidance clarifying how advertising requirements apply to software-based medical devices (SaMD). It emphasises that digital content, including apps and websites, must comply with the Therapeutic Goods Advertising Code, particularly around accuracy and avoiding misleading claims.
- We are going to be launching a daily quiz on RegConnect later this month. Top performers will go into a draw to win RegConnect Summit tickets. Stay tuned!
Action Items
- Conformity Assessment Procedures – our draft response has been uploaded onto the forum groups on RegConnect. If you hadn’t received the notification from the site for the same, please reach out to lwaheed@mtaa.org.au
Hope you all have a restful break.
