April 13th – 17th 2026

Inform Items

1. The TGA has reviewed feedback on its consultation on aligning the Australian Medical Device Essential Principles (Part 2) with European regulation, alongside further stakeholder discussions. This has informed its current position, including where alignment is appropriate and where Australian-specific considerations may apply. The TGA will host a webinar on 13 May (1:00–2:30 pm AEST) to outline their approach, rationale, and key themes from consultation. Stakeholders are invited to register using this link. If you have any questions regarding this event, please contact the TGA at devicereforms@tga.gov.au.

2. The International Medical Device Regulators Forum (IMDRF) draft AI Life Cycle Management document has been published for public consultation, with comments closing on July 10, 2026.  

Action Items

1. Predetermined Change Control Plans – Please share your feedback on the clarity of the PCCP guidance consultation via this link. The consultation will be open for 8 weeks, with submissions due by 27 May to be included in MTAA’s response.