Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems
This consultation closed on 29 April 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 Therapeutic Goods Administration (TGA) regulates these products, and is responsible for implementing the Government's reforms.
Medical devices are regulated in Australia having regard to the risks (to the individual or public health) considered in the context of the device's intended use. The TGA periodically reviews classification rules for medical devices to ensure they continue to be appropriate. When undertaking such reviews, the TGA has regard among other things, to the international best regulatory practice and any emerging issues.
The EU Regulation on medical devices (2017/745) (EU MD Regulation) introduced several amendments to the classification rules effectively reclassifying some categories of medical devices to higher risk classes.
This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. While the new classification rules in the EU more appropriately reflect the intended use and the risks of medical devices, this paper considers the extent to which a similar approach will be appropriate in the Australian regulatory context, to further our aim of enhancing the smooth functioning of the medical devices market while also achieving high standards of quality, safety and performance.
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- Consultation paper: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems (pdf,596kb)*
- Consultation paper: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems (docx,377kb)
Document released for consultation on Wednesday, 6 March 2019.
Interested parties should respond by close of business Monday, 29 April 2019.
Feedback will be released following consideration of submissions. (See 'What will happen').
Submissions must be relevant to the proposed amendments and questions detailed within the consultation paper.
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 email@example.com
What will happen
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Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.
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