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 —
TGA Draft Clinical Evidence Guidelines for Medical Devices

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.


TGA Clinical Evidence Guidelines For Medical Devices



Comment Due Date:

Tuesday, 31 May 2016

Department / Agency:

Therapeutic Goods Administration (TGA)


The draft guidelines outline current TGA expectations for clinical evaluation reports and underlying evidence to be held by medical device manufacturers as part of their conformity assessment procedures. This may be requested by the TGA in support of applications for conformity assessment or inclusion in the Australian Register of Therapeutic Goods (ARTG), and for post market monitoring.


The draft guidelines aim to provide more clarity around the Australian regulatory decision making process and the practicalities of the clinical assessment of medical devices within the Australian regulatory framework. This is firmly based on the evaluation of the clinical evidence of safety and performance of medical devices. The intended result is to assist sponsors and manufacturers to move efficiently through the regulatory system.

The draft guidelines are intended as a supplement to existing guidance documents, such as the Australian Regulatory Guidelines for Medical Devices.

The draft guidelines have been prepared based on experience in assessing clinical evidence submitted by sponsors and manufacturers in the context of conformity assessment, applications for ARTG inclusion and post market activities.

They have also been informed the Royal Australasian College of Surgeons (RACS) series of reports entitled Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S) under contract with the TGA.

The draft guidelines represent the TGA's current views on clinical evidence requirements. Note that the draft does not represent an official or required position, and is provided without prejudice to generate discussion and seek constructive feedback.

The guidelines are intended to assist sponsors and manufacturers of medical devices seeking to supply their products in Australia, to compile relevant and complete clinical evaluation reports for their devices to meet the regulatory requirements.

The draft guidelines have been developed by the TGA taking into account requirements of the Therapeutic Goods Act (Cth) 1989 and the Therapeutic Goods (Medical Devices) Regulations (Cth) 2002. The draft document references and aligns with international guidance documents including those of the Global Harmonization Task Force (GHTF) and the European Commission ‘MEDDEVs’ which are also based on the GHTF (The GHTF no longer exists, and has been permanently replaced by the International Medical Device Regulators Forum) guidelines.


TGA Draft Clinical Evidence Gudelines – Version 1.0 [PDF]

Member Engagement:

ADIA-BAC Business Affairs Committee

Comments To:

ADIA Policy team via email at

ADIA member businesses with an interest in this issue are invited to comment by forwarding your thoughts via email to 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 and by subscribing to the Twitter feed @AusDental. Members requiring further information can send an email to 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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