AusBiotech attends Regulatory and Technical Consultative Forum for medical devices
11 Jun 2025
AusBiotech and members of our MedTech Regulatory Affairs Advisory Group were pleased to participate in the RegTech Forum held at the Therapeutic Goods Administration (TGA) in Canberra on Thursday, 29 May.
The Regulatory and Technical Consultative Forum for medical devices, or RegTech Forum, is a quarterly meeting that provides members the opportunity to discuss issues relating to the regulation of medical devices or technical issues of concern, both current and emerging, and identify options to improve current regulatory practices and compliance. It is an excellent opportunity for AusBiotech to engage directly with the TGA and raise topical issues on behalf of members.
At the RegTech Forum on 29 May the TGA officially launched the Unique Device Identification (UDI) system and database. The launch followed amendments to the Medical Device Regulations by the Government on 24 March 2025 to establish Australia’s UDI system for identifying and tracking medical devices. Through this reform initiative, medical device manufacturers will supply unique identifiers with their high-risk devices. These identifiers can be used in hospital systems and patient records including MyHealth Record to clearly identify the model of medical device used or implanted. As part of this initiative, the TGA has released the Australian UDI database, a public database of device information that will allow patients to access the relevant information about their device. More information is available on the UDI Hub or contact the UDI Support Team at UDI@health.gov.au to join the mailing list.
Other key topics discussed at the RegTech Forum included:
The 2025 MDSAP Forum is being held in Amsterdam from 16-20 June. It will be attended by the five Regulatory Authority members, all Auditing Organisations, the Official Observers (WHO, EU Commission, UK MHRA and Singapore HSA), the MDSAP Affiliate member regulatory authorities, EU notified bodies, EU competent authorities, industry associations, and manufacturers. If any members are interested in virtual attendance at the Forum, please get in touch via MDSAPForum25RSVP@health.gov.au
An update of fees and charges – noting that a proposed 9% reduction in scheduled fees for design examinations related to both medical devices and IVDs has been recommended to the Minister. More public consultation on the fee reduction policy will occur in the coming months.
The TGA is reviewing their cost recovery arrangements for quality management system audits to increase pre-payment before they travel or do the audit, so they can reduce the costs of debt recovery of unpaid fees and charges. They will engage and consult about this work with RegTech members, noting that some of this may require regulation changes to implement fully.
To stay across Regtech forum updates, keep an eye out for future THRIVE editions.