To manufacture an in vitro diagnostic (IVD) medical device for supply in Australia, you must meet safety, quality and performance requirements.
Your IVD must be made under acceptable conformity assessment evidence issued by the TGA or a comparable overseas regulator.
Understanding these rules can help you manage your supply chain risks and meet your legal obligations.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to IVDs. You may also have to meet obligations that apply to all medical devices and all products.
Conformity assessment
Find conformity assessment requirements and variations.
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FormsInformation and templates for manufacturers making an Australian declaration of conformity.
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GuidanceThis guidance outlines ARTG and Conformity Assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.
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PageGuidance and links to information on Conformity Assessment for medical devices.
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PageNew features have been launched for the Medical Devices Consent for Non-compliance Dashboard in TBS Business Services Portal.
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PageThis section is for manufacturers of medical devices and IVDs.
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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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GuidanceGuidance for manufacturers outlining the procedures for submitting Conformity Assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceGuidance explaining sponsor requirements for IVD Conformity Assessment through manufacturer agreements and regulatory compliance.
Auditing
Learn how TGA conducts manufacturing audits and understand your obligations.
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GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device in the Australian Register of Therapeutic Goods.
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GuidanceGuidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods (ARTG).
Certification
Access information on applying for or varying certification.
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FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
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FormsTransfers of conformity assessment certificates.
Evidence
Access evidence requirements for manufacturing medical devices.
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PageClinical evidence guidelines: medical devices have been finalised and are now available
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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
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PageA manufacturer evidence application must be submitted and accepted by the TGA before you can commence an application for any medical device.
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GuidanceGuidance to understand how we interpret regulations and how manufacturers can comply with them.
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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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GuidanceGuidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.
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GuidanceGuidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.
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GuidanceThis guidance is for sponsors of applications for inclusion of medical devices, including in vitro diagnostic (IVD) devices, in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.