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Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs

2 June 2020

This consultation closed on 31 October 2019.

Invitation to comment

The Australian government endorsed a significant program of reform to further strengthen the regulation of medicines and medical devices in Australia. As part of the Australian government, Department of Health, the TGA regulates these products, and is responsible for implementing the government reforms.

In 2015, the Report of the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) made 58 recommendations for reform of the regulatory framework for medicines and medical devices in Australia. The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released in September 2016. The Government accepted 56 MMDR recommendations including Recommendation Twenty[1] which addressed matters within the remit of the TGA. This Recommendation provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework.

The focus of this consultation, which follows on from an external workshop in Feb 2019, is on the proposed reforms to the regulation of systems or procedure packs and the impact of these reforms. The changes proposed in this consultation are intended to facilitate better regulatory compliance and consequently improve safety and quality of medical devices used in system or procedure packs, and will wherever possible align with the EU Framework.

Consultation documents

How to access a pdf or Word document


Document released for consultation on Thursday, 5 September 2019.

Interested parties should respond by close of business Thursday, 31 October 2019.

Feedback will be released following consideration of submissions. (See 'What will happen').

Content of submissions

In addition, submissions may include information on:

  • Suggested improvements.
  • Whether or not you support the proposals, including suggestions for alternatives.
  • An assessment of how the proposal will impact on you.


Any questions relating to submissions should be emailed to

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 feedback on submissions will be provided through this website. Once finalised, the regulatory changes and implementation arrangements will be published 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.