G/TBT/W/781  
 
20 December 2023  
(23-8716) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
MEDICAL DEVICE REGULATION  
TENTH TRIENNIAL REVIEW  
Proposal from Australia  
The following submissi on, dated 20 December  2023, is being circulated at the request of the  
delegation of Australia . 
 
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1  BACKGROUND  
1.1.  Clear, current and effective regulation of medical devices is a necessity to ensure the health 
and safety of consumers. It is important each Members’ right to regulate in the interest of the health 
and safety of their population is respected.  
1.2.  At the same time, i nteroperable regulatory systems, shared systems of nomenclature, and 
systems which can provide for recognition of foreign conformity assessment results can ensure the 
reduction of barriers to trade and avoid delays in consumer access to important, often li fe-saving 
products.  
1.3.  Increasingly, regulatory approvals in one country rely on the work of regulatory authorities or 
the regulatory frameworks in other countries. Misaligned changes to regulations can therefore 
disrupt trade and the supply of critical heal th products before alternate suppliers or regulatory 
arrangements can be established.  
1.4.  The TBT Committee has previously acknowledged the contribution of regulatory convergence in 
supporting the global response to the COVID -19 pandemic and this proposal woul d be consistent 
with continuing to support preparedness for future global health challenges.  
2  PROPOSAL  
2.1.  Australia proposes a thematic session which will explore the current landscape of medical 
device regulation with a view to : 
a. identify ing relevant nexuses for the TBT Committee ; and 
b. promot ing the application of regulatory approaches in accordance with core TBT principles 
to maximise trade and innovation outcomes.  
2.2.  Topics and areas of focus could include:  
a. Exploration of regulatory flexibility/alternatives that leverage valid approaches used 
globally in respect of medical devices, including personalised medical devices  and 
conformity assessment certification, which respond to the need for solutions that are 
globally harmonised, agile, mutually recognised, and consistent with risk -based 
approache s; G/TBT/W/781  
 
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  b. Reliance on consensus -based, international standards to underpin emerging approaches 
to personalised medical devices  and medical device nomenclature , and the potential for 
deepening regulatory cooperation among relevant WTO Member authorities;  
c. Challenge s, limitations, and potential trade implications of conformity assessment 
frameworks in the personalised medical device context;  
d. Presentations by WTO members that are currently developing approaches to medical 
device regulation (including those that may i nvolve certification), with a focus on 
identification of best practices for facilitation of trade;  
e. Presentations by industry regarding regulatory perspectives on emerging regulatory and 
certification approaches . 
2.3.  Australia considers this proposal would be c onsistent with and a relevant continuation of the 
recommendation under Section 8.2 of the 9th Triennial Review.  
 
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