Consultation on 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 documents

• 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)

Timetable

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

• Submissions received

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.

Enquiries

Any questions relating to submissions should be emailed to devicereforms@health.gov.au.

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.

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.