ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

Member Consultation —
Designation of Conformity Assessment Bodies

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To provide businesses across the dental industry with the opportunity to contribute to changes that affect the commercial, technical and regulatory environment the Australian Dental Industry Association (ADIA) seeks member advice and guidance when making representations to government. The following details pertain to an invitation that ADIA has received from the Australian Government to tender comment on behalf of the dental industry.
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Subject:

Designation of conformity assessment bodies for medical devices

Status:

OPEN

Comment Due Date:

Wednesday, 4 January 2017

Department / Agency:

Therapeutic Goods Administration

Background:

The TGA is seeking the advice on the dental industry on the implementation of reforms that will increase flexibility in pre-market assessment processes by enabling the establishment of commercial bodies in Australia designated to undertake medical device assessments, and increasing the use of assessments from comparable overseas regulators.

Purpose:

The TGA is working to support the establishment of commercial bodies in Australia designated to undertake medical device assessments. In the consultation paper the TGA is seeking advice on the proposed implementation of a system to designate bodies to undertake conformity assessment certification of medical devices, including in vitro diagnostic medical devices (IVDs) for the Australian market.

The implementation proposal is similar to that in the European Union whereby there could be multiple bodies, designated by TGA, that are able to undertake conformity assessment certification within Australia. Medical devices certified by these bodies would not undergo application audit by the TGA when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG). These designated bodies could potentially be designated to undertake conformity assessments for all classes of devices or for certain devices only.

Development of this pathway will require the establishment of standards for technical and clinical competence and governance (including management of conflict of interest) which such bodies would need to meet in order to be designated. The removal of the need for an application audit could mean potential saving for industry of 6 months and earlier access for consumers.

Documents:

2016 TGA Designation of Conformity Assessment Bodies Consultation Paper [PDF]

Member Engagement:

ADIA-DRC Dental Regulation Committee

Comments To:

ADIA Policy team via email at canberra@adia.org.au

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ADIA member businesses with an interest in this issue are invited to comment by forwarding your thoughts via email to canberra@adia.org.au by the due date. Although comments of a technical / legal nature are welcome, a simple plain-English statement as to the extent this reform proposal will / will not affect your business is all that's required as such advice greatly assists ADIA in advocating on behalf of the dental industry, particularly in the context of our support for small business.

In pursuing policy reforms the work of the Association is set out in the ADIA Advocacy Agenda that seeks to create an environment in which businesses in the dental industry can grow, create jobs and operate sustainably.

Be sure to keep up to date on this issue by following ADIA on Facebook at www.facebook.com.au/dental.industry and by subscribing to the Twitter feed @AusDental. Members requiring further information can send an email to policy@adia.org.au or telephone 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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