Obtain and maintain regulatory evidence

Understand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG).

Completing a Declaration of Conformity for Class 1 medical devices

30 September 2024

Guidance

Guidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
Overseas regulatory evidence options for a medical device application

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You may be able to use overseas evidence to have your medical device included in the Australian Register of Therapeutic Goods (ARTG).
Australian regulatory evidence options for a medical device application

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Information on Australian evidence options including TGA conformity assessment certification.

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