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Consultation: Draft clinical evidence guidelines - Medical devices

Preliminary draft - Without prejudice

15 March 2016

This consultation closed on 10 June 2016.

The TGA sought comments from interested parties on the draft Medical Devices Clinical Evidence Guidelines.

Consultation documents

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Documents released for consultation on Tuesday, 15 March 2016.

Interested parties should respond by close of business Friday, 10 June 2016.

A consolidated TGA response will be released following consideration of submissions. (see 'What will happen').

About the consultation

What are the guidelines?

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 are intended as a supplement to existing guidance documents, such as the Australian regulatory guidelines for medical devices.

Why are the guidelines being developed?

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.

How have the guidelines been developed?

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 by a series of reports developed by the Royal Australasian College of Surgeons Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S) under contract with 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.

Who are the guidelines for?

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.

Beyond the direct medical devices industry a broad range of stakeholders have significant interest in the clinical guidelines, and submission from interested stakeholders is sought. This may include, but is not limited to, health professionals, academics, health consumers, public and private health providers, and international medical device regulators.

Content of submissions

Submissions are sought from interested stakeholders, on:

  • the utility of the Guidelines document (such as scope, structure, expression, etc.)
  • the clinical and technical requirements it outlines, including any suggested improvements or corrections
  • suggestions for future development of further category specific sections (as covered in Chapter 6)

Submissions received

An overview of submissions and copies of submissions received are available at: Submissions received: Draft clinical evidence guidelines - Medical devices.


Any questions relating to submissions should be directed to the Section Manager, Business Improvement and Support Section, Medical Devices Branch by email to or by telephone to 02 6232 8406.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information). Submissions will be reviewed by the TGA and will inform any necessary revisions, with a view to release of a finalised document on the TGA website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.