Devices - Medical device variant help

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In relation to a ‘kind of medical device’ defined in Section 41 BE of the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002 defines a variant as -
Variant means a medical device the design of which has been varied to accommodate different patient anatomical requirements (for example, relating to the shape, size, length, diameter or gauge of the device), or any other variation approved by the Secretary for the purposes of this definition, provided the variation does not change the intended purpose of the device.

Additional Information
Australian Medical Devices Guidance Document 13 - Variants for Class III and AIMD Medical Devices, available on the TGA website at

https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/medical-device-inclusion-process/what-kind-medical-device-it

provides additional information on what constitutes an acceptable variant for a medical device, and gives instruction on how to complete the variant section in the device application.

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