March 9th – 13th 2026
Inform Items
- The next RegTech meeting will be held on Friday, 20 March 2026.
- There is scheduled system outage – the medical device Consent to Supply and Post Market Review compliance portals will be updated from 6:00 am to 6:00 pm (AEST) on Saturday, 14 March 2026. During this period, the Regulatory and Compliance portal will be unavailable.
- 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
Action Items
- There are three open consultations (available to access on RegConnect under the Resource Hub):
i) Conformity Assessment Procedures – you can populate the feedback excel sheet or the form under the consultation page with your concerns by COB March 25th. We have requested an extension from the TGA but have not received a confirmation. A summary of the meeting held on March 27th with the TGA discussing member concerns is attached.
ii) Determining When News Is Subject To Advertising Rules (New Guidance) – a targeted consultation from the TGA, open for response on the platform until COB Thursday March 19th. This guidance is being developed to promote consistent interpretation of the advertising rules and to help address ongoing non-compliance related to the advertising of therapeutic goods, particularly in evolving digital environment.
iii) Annual Charge Exemption (ACE) Scheme Compliance Program Updates – the proposed amendments relate to the conditions of participation in the TGA’s ACE Scheme. They aim to address issues identified through the ACE Scheme Compliance Program, including rising cases of sponsors not participating in compliance reviews and other instances of non-compliance which have previously gone undetected. This is open for response on the platform until COB Monday March 16th.
Upcoming MTAA Events
- Wed 18 March – MedTech Compass Reimbursement Ready: Essential Insights for MedTech Innovators
- Wed 18 March – Achieving Circularity: Transforming Hospital Polypropylene Waste into Sustainable Solutions
- Wed 15 April – Managing Modern Slavery Risk in MedTech
- Tue 31 March MedTech Compass Pitch Event
- Wed 22 April Beyond the EAP | Embedding Psychological Safety at Work
- Tue 28 Apr – Fri 1 May Sydney – Medical Device Regulatory Workshops
- Mon 4 – Thu 7 May Melbourne – Medical Device Regulatory Workshops
- 27 – 28 May Breaking the Silos: The Women’s Health MedTech Summit
