G/TBT/N/AUS/145  
13 September 2022  
(22-6775) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  AUSTRALIA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Therapeutic Goods Administration  
www.tga.gov.au  
E: udi@health.gov.au  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comm ents 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
Devices supplied into Australia under the Therapeutic Goods Administration's regulatory 
framework.  
5. Title, number of pages and language(s) of the notified document:  Unique Device 
Identification (UDI) Consultation 3 - Detailed considerations for implementing the 
proposed Australian medical device UDI regulatory framework ; (76 page(s), in English ) 
6. Description of content:  The Australian Government is undertaking a significant program 
of reform to the regulation of therapeutic goods in Australia. The reforms will continue to 
improve the safety, performance, and quality of medical devices in Aust ralia and improve 
health outcomes for patients who require medical devices. As part of the Australian 
Government Department of Health and Aged Care, the Therapeutic Goods Administration 
(TGA) regulates therapeutic goods, and is responsible for implementing  the Government's 
reforms, including the introduction of a unique device identification (UDI) system for 
medical devices supplied in Australia.  
Changes to the Therapeutic Goods Act 1989  were passed by the Australian parliament in 
February 2021, to allow f or the establishment of the UDI database and the introduction 
of related requirements. For the system to be operational, there is a need to provide for 
the establishment of the UDI database and for setting out of related requirements, in the 
Therapeutic Go ods (Medical Devices) Regulations 2002 (the MD Regulations).  
This consultation relates to the details of the proposed regulatory framework, including 
seeking feedback on:  
• the impact of accepting both European and USA compliant labels  
• acceleration of delivered benefits through a phased implementation approach  
• scope and exemptions in applying the UDI  G/TBT/N/AUS/145  
 
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  • providing and maintaining data over the full life of the device  
• UDI related fees and charges  
• UDI labelling and supporting documentation  
• any potential regulatory burden  
• adoption and use in the broader healthcare setting  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The Therapeutic Goods Administration (TGA), is responsible for regulating 
medical devices  in Australia.  
The TGA is seeking to amend the Medical Device Regulations  to require manufacturers to 
apply unique device identifiers to medical devices manufactured onshore or imported into 
Australia, to improve patient safety and enhance the ability to track and trace medical 
devices.  
Manufacturers would be required to include the identifiers on packaging of each device 
(in scannable and human readable form), and supply UDI device data to the TGA.  
The device data held in the UDI database will augment data the TGA already stores, and 
will be publicly available at no cost (to hospitals for example who may wish to scan at the 
point of care such as prior to implantation for example, and linked to the patient record).  
Internationally, many other national regulators have either implemented, are in the 
process of, or are plannin g to implement a UDI system. These countries include the UK, 
the EU, Singapore, Canada, Saudi Arabia, Japan, Korea. The USA implemented its UDI 
regulatory framework in 2013, with compliance requirements starting from 2014 for high 
risk devices.  
Work to har monise across country implementations and achieve the benefits of a globally 
harmonised UDI system has been undertaken by the International Medical Device 
Regulators Forum (IMDRF) of which Australia is a member. The IMDRF has published two 
documents - a UDI guidance document (2013) and a UDI application guide (2019) which 
have been used to inform the Australian system.  
Australia is approximately three percent of the global medical device market, and as a 
result many of the devices imported into Australia ar e also supplied to other countries, 
particularly the USA and the EU.  
Any medical devices manufactured in Australia and supplied to other countries must 
comply with the UDI requirements of the country they are supplied to.  
In February 2021 the Australian Pa rliament amended the Therapeutic Goods Act 1989  to 
enable the establishment of a UDI database. The TGA is now consulting on the proposed 
regulatory requirements to operationalise the UDI framework. To maximise global patient 
safety benefits and reduce regu latory burden, the TGA is proposing to align with the 
IMDRF guidance, and both the USA and EU requirements wherever feasible. However a 
small number of Australian -specific requirements are proposed. A consultation paper 
seeking feedback from a broad stakeh older group including sponsors of existing medical 
devices, global device manufacturers, regulatory consultants, consumers, peak bodies 
and the healthcare industry has been released on the TGA website.  
Feedback from this consultation will inform advice pro vided to the Australian Government 
for its consideration of any proposed regulatory changes.; Consumer information, 
labelling; Protection of human health or safety; Harmonization  
8. Relevant documents:   
Unique Device Identification (UDI) Consultation 3 - Detailed considerations for 
implementing the proposed Australian medical device UDI regulatory framework  
This consultation paper is the third consultation paper published by the  TGA relating to 
the Australian implementation of a Unique Device Identification (UDI) System for medical 
devices. It builds on the two previous consultation papers, Proposal to introduce a Unique 
Device Identification (UDI) system for medical devices in Australia , and Consultation: G/TBT/N/AUS/145  
 
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  Exploring options for the introduction of an Australian Unique Device Identification (UDI) 
System . 
9. Proposed date of adoption:  The approach to implementation, including proposed 
mandatory compliance dates, is one of the areas the TGA is seeking feedback on.  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  11 October 2022; We invite you to complete our online survey 
(in the links provided).  
If you prefer, you can make a submission directly to the Department via Australia's TBT 
Enquiry Point.  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://consultations.tga.gov.au/tga/udi -consultation -paper -
3/supporting_documents/UDI%20consultation%20paper%203%20%20Detailed%20con
siderations%20for%20implementing%20the%20proposed%20Australian%20me dical%2
0device%20UDI%20Regulatory%20Framework%202022.pdf  
https://consultations.tga.gov.au/tga/udi -consultation -paper -3/