Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy
This consultation closed on 18 February 2019.
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.
Having regard to the amendments implemented by the EU MD Regulation, TGA is proposing to introduce a new classification rule, which is appropriately tailored for the Australian regulatory context, for active medical devices with an integrated or incorporated diagnostic function that significantly determines patient management.
While the new classification rule in the EU more appropriately reflects the intended use and the risk of medical devices, this consultation considers the extent to which a similar approach will be appropriate in the Australian regulatory context, while also achieving high standards of quality, safety and performance.
- Consultation paper: Potential reclassification of active medical devices for diagnosis and patient therapy (pdf,264kb)
- Consultation paper: Potential reclassification of active medical devices for diagnosis and patient therapy (docx,118kb)
Document released for consultation on Monday, 7 January 2019.
Interested parties should respond by close of business Monday, 18 February 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 firstname.lastname@example.org.
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.
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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