June 15th – 19th 2026
Inform Items
- The Road to RegConnect quiz is coming soon! Running from 29 June to 31 July, it’s a month-long quiz challenge featuring a new regulatory question posted daily on the RegConnect platform. Members accumulate points for correct answers, with the top two scorers winning tickets to the RegConnect Summit (24–25 September, ICC Sydney)! More details to come in next week’s update, so keep an eye out.
- The TGA is hosting a webinar on 23 June 2026 on its proposal to confidentially share commercially sensitive therapeutic goods data with government authorities, to support health emergency preparedness and supply chain vulnerability responses. The webinar will update respondents to the TGA’s earlier 2026 consultation on how the proposal has evolved based on feedback received. The session is co-hosted with the Department of Industry, Science and Resources’ Office of Supply Chain Resilience. Register here.
Action Items
- Proposed regulatory amendments to allow Instructions for Use (IFUs) for medical devices to be provided in more flexible formats are scheduled for consideration by the Executive Council at its August meeting. If approved, implementation is anticipated between August and September 2026. The TGA’s eIFU guidance document is currently being updated to reflect the proposed changes. Members with feedback are encouraged to share input via RegConnect by 23 June.
- The IMDRF Quality Management Systems Working Group is seeking feedback on its draft Guidance on the Control of Products and Services Obtained from Suppliers, ahead of finalisation for publication. Members are encouraged to share views by 29 June.
- The IMDRF has opened public consultation on its draft Technical Framework for Artificial Intelligence Life Cycle Management (Document N93). Members with feedback are encouraged to share input via RegConnect by 3 July.
- The UK MHRA has published proposed changes to pre-market regulatory requirements for medical devices and IVDs in Great Britain, including a reliance mechanism for manufacturers with TGA conformity assessment certification. MTAA is treating this as a priority consultation given strong TGA interest in industry input. Members with feedback are encouraged to share input via RegConnect by 3 July.
