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GuidanceGuidance 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.
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PageYou may be able to use overseas evidence to have your medical device included in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation on Australian evidence options including TGA conformity assessment certification.
Obtain and maintain regulatory evidence
Understand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG).