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Medical devices reforms: Low risk products - Class 1 medical devices

Project status: in progress

14 January 2021

Project overview

Appropriate regulation of low risk devices improves their availability.

The regulation of low risk Class I medical devices is still under review, to remove unnecessary regulation while ensuring these products are appropriately regulated.

Completed work includes:

Ongoing work includes:

For more information see The future regulation of low risk products.

For more information about consultations on reforms to low risk devices, visit Medical device reforms: Low risk products.

Guidance for industry

For general guidance on Class I medical devices see:

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Please contact the TGA at devices@health.gov.au if you have any queries or comments.

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For more information about other reforms visit Medical devices reforms.