May 18th – 22nd 2026
Inform Items
- Please be advised that a scheduled software update is planned from Friday 12 June, 9:00 pm to Saturday 14 June, 8:00 am AEDT. During this time, access to the Medical Device Adverse Event Reporting System may experience disruptions or may not be available. The TGA encourages you to plan your activities accordingly to mitigate any inconvenience. Should you require urgent access to the system, or if you have concerns during or following the update period, please contact their support team at IRIS@health.gov.au for assistance.
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Following the successful Beta demonstration period from Nov-Feb, the TGA has provided some updates on the Modernising our Digital Systems web page. They are finalising the technical scope based on the feedback during Beta and consulting with industry, including discussions with the Industry Working Group on release timing and how best to support the transition. They will share further detail as planning progresses, and are grateful to everyone who participated in the Beta period, as all feedback is valuable. The insights shared have helped them make targeted improvements that will be featured this year as well in future releases. They will continue to update the website regularly in the lead up to the go live. If you have any questions, please contact the team at TGADigitalStakeholders@health.gov.au.
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The TGA is reviewing the Medical Devices Vigilance Program (MDVP) pilot and is seeking member feedback, particularly from those with medicines vigilance experience. Contact mdvp@health.gov.au to contribute.
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The TGA has recently published resources to help sponsors and manufacturers access and use the AusUDID, covering submission methods, roles and responsibilities, and troubleshooting.
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The TGA has published a guide on applying for consent to import/supply/export medical devices that don’t meet UDI-related Essential Principles, covering the application process and a reduced fee structure from 1 July 2026. Note: the streamlined process and reduced fee won’t apply to sponsors who submit a UDI CTS before 1 July 2026.
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The TGA is seeking TBS users to participate in one-on-one virtual research sessions (up to one hour, late May–mid-June) to inform the transition to the new Health Business Services Portal. Spaces are limited – register your interest via this 5-minute survey or contact TGADigitalStakeholders@health.gov.au with any questions.
- From 1 May 2026, the case management team are providing sponsors with monthly status updates for each application audit. This aims to assist sponsors with timely information about the progress of their applications in the audit process.
Action Items
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Predetermined Change Control Plans – Please share your feedback on the clarity of the PCCP guidance via this link by 27 May to be included in MTAA’s response.
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UDI Audit Selection Criteria – The TGA is seeking targeted stakeholder feedback on proposed additional text for the guidance document: Understanding selection criteria for medical device application audits | Therapeutic Goods Administration (TGA). The proposed update clarifies how UDI requirements will be applied to new applications for Class IIb and Class III devices from 1 July, including how these requirements may be considered in audit selection. The draft text to be added has been uploaded onto the RegConnect platform for review, please comment any feedback you may have below the post by 8 June to be included in MTAA’s response.
Upcoming MTAA Events
- MTAA’s Breaking the Silos: Women’s Health MedTech Summit is taking place next Wednesday and Thursday at Doltone House Hyde Park, Sydney. With a full agenda of speakers confirmed across two days, this is a not-to-miss event for anyone working in or passionate about women’s health and medical technology. We encourage members to register now and spread the word within your networks!
