Reforms To Permit New Conformity Assessment Bodies
23rd Jan 17
As a result of lobbying by ADIA, a major overhaul of the medical devices regulatory system is underway that will permit third-party conformity assessment bodies to operate in Australia, something that provides dental product suppliers with more certification options.
Key Issues For The Dental Industry —
The recent review of medicines and medical device regulation recommended that provision be made for conformity assessment of medical devices to occur in Australia by private bodies designated by the Therapeutic Goods Administration (TGA) to appraise the suitability of the manufacturing process (“conformity assessment procedures”) for devices that are manufactured in Australia, and to assess whether such devices meet minimum standards of safety and performance.
As the peak business organisation representing manufacturers and suppliers of dental products, the Australian Dental Industry Association (ADIA) was one of a number of stakeholders that initiated discussion on this reform and, endorsed the resulting recommendation and successfully lobbied the Australian Government for its adoption.
The TGA has now sought advice from ADIA as to the practical issues associated with its adoption. Developed by members serving on the ADIA-DRC Dental Regulation Committee, the advice tendered on behalf of the dental industry included:
Existing Framework Preservation —
ADIA has supported retention by the TGA of several aspects of the existing regulatory approval including the use of Existing Principles (the required product design, performance and safety standards) and the attendant conformity assessment procedures.
Partial Designation —
ADIA is supportive of a process that allows Australian conformity assessment bodies to achieve partial designation from the TGA for certain classification of medical devices (e .g. Class IIB and lower). This is particularly relevant to the dental industry where the majority of products are of a relatively low-risk nature. The practical outcome is that the TGA may only designate an Australian conformity assessment body to undertake certification for only some types and / or classes of medical devices.
Establishment Of New Conformity Assessment Bodies —
In ADIA's discussions with the TGA, and in the TGA's paper canvassing reform implementation, the regulator had questioned whether there would be sufficient interest from appropriately credentialed bodies to establish themselves as conformity assessment bodies within Australia. ADIA has tendered advice that size of the Australian market coupled with a strong and growing domestic medical device manufacturing capacity provides scope for a limited number of specialised businesses to work as competent authorities within the Australian regulatory system. It is likely that, in the initial stages, these would be modest in number yet the benefit that they will provide to the Australian market would be considerable
TGA Funding Of Designation Activities —
That cost-recovery nature of the TGA's operations produces several anomalies where businesses in the dental industry, and the broader medical devices sector, are funding government activities that can be strongly argued are a matter of public interest and therefore the costs should be met from an annual budget appropriation rather than TGA fees and charges. ADIA is of the view that the TGA's activities associated with the designation of Australian notified bodies are regulatory responsibilities that should be met, in their entirety, from an annual budget appropriation and not from industry.
Competitive Neutrality —
The paper outlining the proposed implementation framework implies that the TGA itself will continue to operate as a conformity assessment body. In this scenario, the TGA will be competing with the private sector insofar as its conformity assessment body activities are concerned. ADIA has advised that this is not acceptable in an environment in which the TGA is in a position to subsidise, directly or indirectly, conformity assessment activities.
ADIA recommends that once a private-sector organisation has commenced the process of seeking TGA-designation as a conformity assessment body, the TGA implements the necessary changes so that, consistent with competitive neutrality principles, its own conformity assessment activities enjoy no net competitive advantaging owing to its Australian Government affiliation.
From the perspective of the dental industry, it is envisaged that new conformity assessment bodies designated by the TGA will provide an alternative avenue (other than the TGA) for manufacturers of medical devices to obtain a conformity assessment certificate required before their medical devices may be included in the Register by the TGA.
ADIA continues to provide advice and guidance to the Australian Government on this matter and is currently reviewing the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 that will amend the Therapeutic Goods Act (Cth) 1989 in order to allow the TGA to progress this reform.
This is a major reform for the dental industry and reflects the commitments made in the ADIA Advocacy Agenda to ensure that the medical device regulatory framework is based ased on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden. Resources to achieve this have been made available by the ADIA Board as a result of commitments made in the 2016-20 ADIA Strategic Plan.
Member Engagement —
Businesses that manufacture and supply dental products drive ADIA's policy advocacy priorities and, with respect to the regulation of therapeutic goods, do this through the ADIA-DRC Dental Regulation Committee with updates provided at the quarterly ADIA State Branch Briefings. If your business has an interest in this matter, get involved today.
Further Information —
For further information for ADIA's activities to support dental product manufacturers and suppliers in this area contact the ADIA Advocacy Team via email at firstname.lastname@example.org. To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.
Currency Of Information & Disclaimer —
This update was issued on 23 January 2017 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, images and where stated.
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