TGA Revises Dental Laboratory Product Standards
17th Mar 16
As a result of ADIA's policy advocacy the TGA has revised the regulatory arrangements for dental laboratory products that introduce new mandatory reporting requirements and have confirmed that crowns, bridges, dentures and similar products need to meet the same design and performance standards whether made locally or overseas.
Key Issues For The Dental Industry —
The regulatory standards for laboratory work (referred to as custom-made medical devices for regulatory purposes) are enforced by the Therapeutic Goods Administration (TGA) pursuant to the provisions of the Therapeutic Goods Act (Cth) 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.
For more than a decade the Australian Dental Industry Association (ADIA) has been working with the TGA to ensure that dental laboratory products meet the same regulatory standards irrespective of source.
After advocacy at a parliamentary and departmental level, ADIA has been able to secure some important reforms that confirm the regulatory standards for dental laboratory products and revise the mandatory reporting arrangements. The outcome is a regulatory framework that:
||Defines the required design and performance standards; and
||Requires a local laboratory or importer to notify the TGA or their operations.
Importantly, these obligations are common to all suppliers of dental laboratory products in Australia, whether they be supplied by a local laboratory, an importing wholesaler or a dentist importing the product from overseas.
ADIA has welcomed the leadership shown by the TGA and its senior staff in working with the dental industry to deliver these important reforms that support the sector.
The reporting requirements are the result of a recent regulatory amendment secured by ADIA. Within two months of commencing local manufacturing or importing the product, there is now a requirement that the TGA be notified of the activity and, in so doing, a further requirement to provide information about the manufacturer to the TGA. Further information can be found online at:
Additional online information —
TGA Regulatory requirements for dental laboratory products
The enclosed brochure sets out these requirements in more detail. Consistent with ADIA’s agenda of keeping red-tape to a minimum, there is only a requirement to notify the TGA when supply commences (i.e. in the first instance) and not every time a dental laboratory or importer supplies a product. ADIA’s work in this area was possible as a result of the support and guidance that we receive from members and I encourage you to consider becoming involved in ADIA’s policy advocacy activities
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. On matters associated with regulation of dental laboratory products ADIA staff receive advice and guidance from members that belong to the ADIA-LIG Laboratory Interest Group and who serve on the ADIA-DRC Dental Regulation Committee.
Currency of Information —
This update was issued on 15 March 2016 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations.
The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This publication 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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