medical device regulation
TENTH TRIENNIAL REVIEW
Proposal from Australia
Revision
The
following submission, dated 1 March 2024, 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, interoperable 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 life-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 health 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 would 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._
identifying
relevant nexuses for the TBT Committee;
b._ drawing
on the expertise and experiences of relevant stakeholders, through inviting a
diverse range of speakers including government regulators, the private sector
and international organisations; and
c._ promoting
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 approaches;
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._ Challenges,
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 involve 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; and
f._ The
importance of transparency and procedural fairness in designing and
implementing regulations, including sufficient time for industry consultation
and comment.
2.3. Australia
considers this proposal would be consistent with and a relevant continuation of
the recommendation under Section 8.2 of the 9th Triennial Review.
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