The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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7 result(s) found, displaying 1 to 7
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GuidanceAn overview on the application process for manufacturers aiming to obtain a TGA-issued conformity assessment certificate.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, conformity assessment certificates.
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GuidanceGuidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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GuidanceThis guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
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GuidanceGuidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).
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GuidanceGuidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).