April 7th – 10th 2026
Inform Items
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The TGA thanks you for providing feedback on the consultation paper Australian Medical Device Essential Principles – Part 2: Proposed alignment with the European Regulation. They have carefully considered the feedback received, alongside further targeted discussions with stakeholders. The feedback and discussions have informed the TGA’s current thinking on potential changes to the medical device Essential Principles, including areas where alignment is already achieved and where Australian‑specific considerations may be warranted.
The TGA will be hosting a webinar to outline this current position, explain the rationale for the approach being taken, and highlight key considerations raised during consultation.The session is intended to provide transparency on the outcomes of the consultation and how stakeholder input has informed the TGA’s thinking. Stakeholders are invited to register to attend. The webinar is to be held on Wednesday, 13 May 2026, between 1:00 pm – 2:30 pm (UTC+10:00).
Registration: Please register for the webinar using this registration link. If you have any questions regarding this event, please contact the TGA at devicereforms@tga.gov.au.
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The upcoming regulatory amendments relating to electronic instructions for use (eIFU), pre‑filled saline flush syringes and vascular access devices, and clinical decision support systems (CDSS) have been delayed. These amendments are now expected to be considered in June 2026. The TGA will continue to keep stakeholders informed as further information becomes available.
Action Items
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Predetermined Change Control Plans – We’ve uploaded a consultation on the TGA’s draft guidance for PCCPs. Please share your feedback on the clarity of the guidance via this link. The consultation will be open for 8 weeks, with submissions due by 27 May to be included in MTAA’s response.
- Conformity Assessment Procedures – our draft response has been uploaded onto the forum groups on RegConnect for member review. We will be submitting our feedback on 14 April.
