TGA Update for ODMA Members
Please find here a summary of recent TGA updates that may be of relevance to you
Firstly before we get started….if the implementation of Unique Device Identifiers or changes to classifications of medical devices considered software-based or including software, are going to significantly affect your business please let me know if you wish to be involved in the Consultation Committee that has been established by the TGA or if you wish me to set up a zoom with the project manager at TGA or indeed invite them to attend a roundtable at ODMAFair25 or something of that nature. Otherwise, we will presume that you have your own organisational representative who is engaging directly with the TGA on relevant projects as required, and if so, it would be great to be advised of that and who that main contact in your organisation is. Thanks and now for the update….
Recent RegTech Meeting
ODMA attended the recent all-day Regulatory and Technical Consultative Forum on 27 Nov. Anyone wanting full minutes of this meeting, Amanda is happy to share them once they are provided.
The main points discussed were:
Recalls – statistics now available. Most device recalls are at the hospital level, not retail or consumer. Revised recall procedure available which have been simplified and content reduced.
Dept of Industry, Science and Research provided an update on sovereign and domestic manufacturing initiatives and grants for the medical sector
Each industry in attendance provided an update of their forward focus and main WIP matters relating to TGA
TGA provided an update on all projects in progress – main notes for optical being:
Exempt Medical Devices – consultation paper sought views on policy proposals for change which driven by the lack of awareness and understanding by manufacturers/sponsors of regulatory obligations for these goods, and difficulties in recall or managing safety issues.
Medical device reforms – Technical Reference Group for software as medical device and AI has been established. List of who on it and statement of outcomes from first meetings are on the TGA website.
Transformation - A presentation was provided on the new digital platform and dashboards and use of MyID. A new dashboard will be developed to allow applicants to track the status of various components of their applications (e.g. clinical, technical) and will be available for industry viewing in 2026. The timeline for the new system to accept applications for medical devices, will be after 1 July 2025.
UDI (Unique Device Identification) project update was provided – namely :
TGA are establishing an Australian UDI system
Updates to the AusUDID system have been based on pre-production feedback, and adjustments made to accommodate devices with multiple sponsors
Roadshows with information will be conducted in 2025
Draft UDI Guidance and Dictionary has been reviewed by several volunteer sponsors
Standardisation required given the need for multiple identifiers
Timeline is voluntary compliance 2025 then through to 2027 given EU MDR extended timeline has had an impact
Different rules for devices sold in retail for POS packaging
Obligation is on the manufacturer/supplier
UDI hub is coming
Recent Bulletins from the TGA with information that may affect your business
Software-based Medical Devices – upcoming transition deadline
This is a reminder that the deadline for transitioning software-based medical devices ended on 1 November 2024.
While the transition deadline was extended for the reclassification of certain medical devices.
New classification rules for software-based medical devices were introduced on 25 February 2021. Sponsors who submitted notifications to the TGA for their existing software-based products became eligible for the transition period for their products, but they must now submit a new application for inclusion in the ARTG at the correct classification or an application for conformity assessment before 1 November 2024.
Any sponsors that do not transition their products will need to cease supply and cancel existing ARTG entries. For more information, please refer to detailed guidance on our website.
If you have any questions, please feel free to contact postmarketdevices@health.gov.au.
Announcements
An update to the Australian UDI Database (AusUDID) Pre-Production environment
We released substantial changes to the AusUDID Pre-Production environment on 27 November 2024 which is now available for your use and feedback. The release includes:
enhancements to cater for the multiple sponsor capabilities, based on prior consultations
changes to the AusUDID database structure
fixes to system issues
updates to the Bulk Upload template and Australian UDI Data Dictionary
removal of all existing data.
The full release notes are available here.
We are seeking your feedback on the AusUDID Pre-Production
The Pre-Production version is now available to all users with a valid TGA Business Systems (TBS) account.
You can submit individual UDI records through the online portal and create many records at a time via the Bulk Upload template.
Because of the changes to the database structure, you will need to download version 2.3 of the Bulk Upload template. This can be downloaded from the AusUDID portal (‘Bulk Edit UDIs’ tab).
The Machine to Machine (M2M) submission – HL7 SPL and National Product Catalogue (NPC) – methods have not been system/regression tested and should not be used at this time. A future release for these submission methods is coming soon and we will notify you when available.
If you have not used AusUDID Pre-Production before and you are interested in doing so, please contact us at UDI@health.gov.au.
Updates to the UDI Hub
We are also updating the UDI Hub, and you will see changes to:
Draft Australian UDI Data Dictionary | Therapeutic Goods Administration (TGA)
Unique Device Identification (UDI) glossary | Therapeutic Goods Administration (TGA)
Australian UDI Database release notes | Therapeutic Goods Administration (TGA).
Further updates are underway, which will be completed in the coming weeks. This will include publication of a draft version of the UDI Guidance.
DISR’s consultation on mandatory guardrails for AI in high-risk settings
TGA response to DISR's public consultation paper: Proposals paper for introducing mandatory guardrails for AI in high-risk settings is now published.
Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination (No. 2) 2024
Confirmation that the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination (No. 2) 2024 has been registered.
The amendments include pathways for Class III medical devices and Class IIa devices (exempt from USFDA regulation).
Class III: MDSAP Certification + USFDA 510(K) clearance
Class IIa devices (exempt from USFDA regulation): MDSAP Certification + exemption from USFDA 510(K) regulation
At this stage, the amendments to the instrument are available at: https://www.legislation.gov.au/F2024L01328/latest/text.
The consolidated instrument will follow shortly.
The TGA can now accept MDSAP Certification + USFDA 510(K) clearance for Class III medical devices.
Australian Unique Device Identification Guidance Consultation
The draft UDI Guidance document is now available for external review and feedback via the TGA Consultation Hub.
You can find the document, and provide your comments via our survey, here: Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices - Therapeutic Goods Administration - Citizen Space
Please note: the consultation closes on 15 January 2025.
This document has been drafted in anticipation of changes to the Therapeutic Goods (Medical Devices) Regulations 2002. Please note that the content is subject to change as the regulations are yet to be approved by the Australian Government.
The UDI guidance has been developed to help sponsors and manufacturers of medical devices understand the regulatory obligations under therapeutic goods legislation.
Specifically, the document covers:
medical devices and in vitro diagnostic (IVD) medical devices included in Unique Device Identification (UDI) regulations
labelling requirements
data submission requirements
specific device requirements.
This document outlines the processes to get and apply a UDI and submit and maintain UDI data in the Australian UDI Database (AusUDID).
Scan QR COde to access document
EU MDR transition - Multiple manufacturer evidence and kind of device
We have recently received an increase of new applications for medical device inclusion to the Australian Register of Therapeutic Goods (ARTG) related to EU MDR transition and some confusion about the requirements related to manufacturer evidence.
An ARTG entry allows the supply of any medical device of the same kind, regardless of the specific conformity assessment document supporting each device. The conformity assessment document linked to an ARTG entry does not restrict supply to only those devices covered by that specific document.
You may request a Device Change Request (DCR) to update the Manufacturer Evidence linked to an ARTG entry. However, the timeframes for DCR approval will not affect your ability to supply devices already listed on the ARTG. While waiting for DCR approval, you may continue to supply devices of the same kind supported by EU MDR certificates, as long as they comply with other regulatory requirements, including the essential principles. If you already have an ARTG entry for a kind of medical device, you do not need a new ARTG entry based on an EU MDR certificate to continue supplying the product when transitioning from MDD to MDR. Separate ARTG entries are not required for devices of the same kind supported by different conformity assessment documents.
Our guidance documents published to assist with the EU MDR transition help Australian medical device suppliers and users transition. EU MDR transition – manufacturer evidence (Case Studies and scenarios) includes scenarios involving multiple Manufacturer Evidence certificates for devices of the same kind.
If you have further questions, please refer to the guidance documents or contact us directly for clarification.
Exempt medical devices and OTGs – Date nominations for sector specific workshops
We are organising sector specific workshops to further discuss proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods.
Medical device sponsors and manufacturers of the product categories mentioned in the consultation paper or recent workshops are strongly encouraged to attend these workshops.
The workshops will be held in Feb/Mar 2025. Please fill out this survey on date nominations to assist us with scheduling – Scheduling Poll Survey
Please reach out to devicereforms@tga.gov.au if you have any questions.
What’s new
New page
Updates to the patient-matched medical device transition notification
How to submit a custom-made medical device and patient-matched medical device notification
Refinements to the Personalised Medical Device Framework
Understanding personalised medical devices rules (including 3D-printed devices)
Medical devices reforms: Personalised medical devices
Updated page
IMDRF Personalised Medical Devices (PMDs) Working Group
Membership updated
Next RegTech meeting is scheduled for 27 Feb if you have any matters of concern you want raised.
Key points from the TGA Bilateral meeting held 26 Nov
TGA focus for 2025 is:
New portal (built on Microsoft technology, website guidance improvements, more self-serve and less repetition of data entry, can’t lodge until mistakes fixed for faster approvals) – users will have access to old system still. Devices won’t be on this until 2026 onwards. Change of address will be self-serve. Credit card payments will be encouraged for faster processing times.
Strengthened compliance and managing the huge uplift in referrals (mainly via BorderForce and public and in nicotine related areas). There will be more education for devices on regulatory obligations and support for emerging technologies.
Unlawful advertisements
Medicine and device shortage/supply disruptions
International collaboration
Emerging Technology e.g. AI
Charges increase yet to be finalised, and paper will be released in early 2025 (in the vicinity of 3%; however, some fees will be reduced, and looking at including several devices on one application, and there will be a consultation on what constitutes a bundle).
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