Conformity Assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles.
From 28 July 2021, devices that were previously described under regulation 4.1 (those that contain medicines or materials of animal, microbial, recombinant or human origin, and Class 4 IVDs) no longer require mandatory TGA Conformity Assessment certification.
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PageGuidance and links to information on Conformity Assessment for medical devices.
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DatasetSearch Conformity Assessment (CA) certificates that we issue to manufacturers of medical devices.
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Corporate reportsInformation on Conformity Assessment of in vitro diagnostic medical devices (IVDs).
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FormsAccess TGA medical device Conformity Assessment application forms and guidance, including requirements for supporting data and certification.
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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 ARTG and Conformity Assessment requirements for immunohaematology reagents (IHRs).
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PageOur approach to delays in overseas and Australian Conformity Assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
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Corporate reportsGuidance for reducing assessment fees for ARTG application audits and TGA Conformity Assessments of medical devices (including IVDs).
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FormsInformation on when a manufacturer's statutory declaration should be provided.
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PageAustralian corporations can apply to become an Australian Conformity Assessment Body (CAB), enabling them to assess medical devices against regulatory requirements.
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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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