ADIA Secures key reforms to medical device regulation
15th Sep 16
In its response to a review of medicines and medical device regulation, the Australian Government has accepted recommendations from the Australian Dental Industry Association (ADIA) that will see further regulatory harmonisation with the EU and simplify domestic approval pathways for dental products through greater use of overseas assessment reports and provisional approvals.
Key Issues For Consideration —
In 2014 the Australian Government announced a review of the medicines and medical devices regulatory framework. In order to ensure that the review identified reforms that reduced the red-tape burden faced by manufacturers and suppliers of dental products, ADIA tendered a submission to the panel undertaking the review and subsequently met with the panel.
An interim report was issued in March 2015 and a further report in July 2015; however, the recommendations in these reports were subject to consideration by the Minister for Health who has now issued the response. The relevant documents can be downloaded via the links below:
Once the reports were released, ADIA embarked upon an advocacy campaign that ensured that key departmental and parliamentary stakeholders to ensure that the outcomes important to the dental industry were secured. It is pleasing to note that all of the key reforms that ADIA had sought on behalf of the dental industry have been accepted in the response issued by the Minister for Health on 15 September 2016 and are are as summarised below:
Overall Direction Of Reform —
The Australian Government acknowledges that there are positive outcomes to be found in harmonising international regulatory frameworks, noting that there are benefits for consumers and efficiencies for industry from greater harmonisation. The proposed program of reform that’s relevant to the dental industry involves:
||Increasing use of overseas assessments with comparable regulators, while maintaining sovereignty of regulatory decisions;
||Increasing flexibility in pre-market assessment processes for medicines and medical devices, including expedited and provisional approval and allowing the operation of commercial assessment bodies in Australia for medical device assessments;
||Taking a risk-based approach to variations to medicines and medical devices and access to products not listed in the Australian Register of Therapeutic Goods (ARTG);
||Enhancing post-market monitoring and improving integration of administrative arrangements relating to pre- and post-market processes for subsidy and other purposes; and
||Simplifying processes by which advertising of therapeutic products to the public is regulated;
To this end, the reforms are directed at allowing for greater flexibility in approval pathways for medical devices that includes including greater use of overseas assessment reports and provisional approvals in certain circumstances. The intended outcome is to expedite access to the Australian market without compromising the safety, quality and efficacy or performance of medicines and medical devices.
There are some issues that ADIA has identified as being of major importance to the dental industry and the reforms relevant to these issues are summarised below:
ARTG Inclusion of Class 1 Medical Devices [Recommendation 15]
Although some stakeholders (including some in the medical device sector) had argued that Class 1 medical devices be removed from the ARTG, the Australian Government has accepted ADIA’s advice that Class 1, non-sterile and non-measuring devices, continue to be included in the ARTG on the basis of a self-assessment by the device manufacturer.
Reclassification of Class 1 Medical Devices [Recommendation 23]
That the Australian Government undertake a review of the range of products currently classified as Class 1 medical devices, with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions. In discussions with the TGA it is understood that most dental products would fall outside the scope of this review; however, the Australian Government has committed to further consultation with ADIA on this matter.
Conformity Assessment [Recommendation 15]
That there be two pathways to provide access to the Australian market.
The first is that Conformity Assessment to occur within Australia by either the TGA or a body designated by the TGA to undertake Conformity Assessments of medical devices for the Australian market.
The second is a major change and will permit utilisation of marketing approval for the device in an overseas market in circumstances where the device has been: Conformity Assessed by a body that has been designated to undertake Conformity Assessments by a comparable overseas Designating Authority (the national authority with responsibility for the designation, monitoring and control of organisations that provide accepted Conformity Assessments); or Approved by a comparable overseas regulator.
Designation of Conformity Assessment Bodies [Recommendation 16]
The Australian Government will develop transparent criteria that it will utilise in order to designate suitably qualified bodies within Australia to undertake Conformity Assessments of medical devices. The criteria will include capacity to set specific requirements for different classes of medical devices and be developed in consultation with the medical devices sector and other stakeholders.
Identifying Overseas Bodies [Recommendation 17]
The Australian Government will develop and apply transparent criteria for identifying comparable overseas Designating Authorities and comparable overseas regulators for the evaluation of medical devices; however, acceptance is in-principle only, noting that development of criteria will be subject to further consultation with relevant stakeholders including the medical devices sector.
EU Framework Alignment [Recommendation 20]
The regulation of medical devices by the TGA will be, wherever possible, aligned with the European Union framework including in respect of the: Classification of medical devices; Essential Principles / Requirements; and Adoption of a risk-based approach to variations to medical devices.
Legislative Enforcement [Recommendation 28]
The Australian Government will undertake a comprehensive review of the legislative framework underpinning the regulation of therapeutic goods, including a review of the Therapeutic Goods Act (Cth)1989 and associated Regulations in their entirety, with a view to providing graduated penalties that allow the TGA to respond appropriately to the full range of non-compliance from repeated minor breaches through to serious non-compliance; however, acceptance is in-principle only and ADIA needs to demonstrate that the benefits of redrafting and implementing new legislation would outweigh the costs of doing so.
Regulatory Decision Making [Recommendation 29]
The Australian Government has accepted the advice of ADIA and other stakeholders to reject a change that would have seen the decision making process for the inclusion of medicines and medical devices in the ARTG to be the responsibility of the Australian Government’s Chief Medical Officer.
The Australian Government has also accepted advice from ADIA and other stakeholders to reject a recommendation to establish a statutory committee to make recommendations to the Chief Medical Officer about inclusion of a medical device in the ARTG.
Therapeutic Goods Advertising
There are further recommendations associated with the advertising of therapeutic products that are the subject of further discussion with the TGA and will be considered by the ADIA-DRC Dental Regulation Committee in more detail over the coming year.
These reforms are good news for the ADIA membership - the magnitude of the change will simplify approval pathways for medical devices through greater use of overseas assessment reports and provisional approvals in certain circumstances. Following ADIA's discussions with both the TGA and the Minister for Health, there is a high degree of confidence that the reforms will be enacted in a timely manner.
ADIA is scheduled to meet with the TGA in late September 2016 in what is expected to be the first of a series of briefings to progress the reforms.
Member engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to matters associated with medical device regulation, ADIA staff responsible for policy advocacy receive advice and guidance from members serving on the ADIA-DRC Dental Regulation Committee.
Currency of Information —
This update was issued on 15 September 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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