Advocacy — Best practice product regulation
The Australian community has the right to access, within a reasonable time, therapeutic advances. This is secured when the regulatory framework for medical devices (dental product) is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.
Strategic priority —
Ensure that the regulatory standards for medical devices are commensurate with the level of risk and the approval process is streamlined - free of unnecessary statutory obligations.
Actions required by government —
The regulatory framework permits an increased number of medical devices onto the Australian market
aaas a means of improving clinical outcomes.
Acceptance of third party conformity assessments be accelerated
Alignment of the great variety of codes used to identify medical devices, in order to facilitate more
aaefficient regulation and more rapid identification of devices.
Introducing a requirement for custom-made dental appliances for a statement of manufacture to
aabe provided to patients, and retained by the dental practitioner.
Reviewing regulatory enforcement options to ensure the importation of medical devices via the
aainternet is both enforceable and enforced.
A net benefit approach to new and existing regulation.
Appropriate accountability to ensure that essential objectives of medical device regulation are
aaachieved without unduly restricting or impacting on business.
Increased transparency in TGA regulatory decision making and compliance activities.
A new approach to regulatory compliance that provides for issuance of infringement notices in
aaaddition to existing civil and criminal penalties.
Advocacy partner —
ADIA’s partner in delivering outcomes across this policy area is the association of International Dental Manufacturers (IDM).
Industry benefits —
The direct outcome for ADIA member businesses are increased profitability, business growth and job creation as a result of being able to make available a greater range of dental products without the burden of excessive regulation.
This priority reflects ADIA's commitment to ensure a strong, dynamic and globally competitive Australian economy by advancing the cause of economic reform. The reforms set out above are part of a considered and balanced reform agenda that will achieve a number of outcomes including lowering and simplifying taxes, streamlining the federation, reducing the size of government, eliminating red-tape, improving efficiency and enhancing our national productivity.
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. The issues that ADIA staff progress progresses at a parliamentary and departmental level are identified by members serving on the ADIA-TCPC Trade & Commercial Policy Committee and the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
If you have an interest in ADIA's work at a parliamentary and departmental level to secure the policy reforms that support businesses in the dental industry, for updates subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at email@example.com or by telephone on 1300 943 094.
This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
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