If you're planning to bring an in vitro diagnostic (IVD) device to market in Australia, this is your starting point.
You need to understand how IVDs are regulated, the regulatory requirements, and your obligations.
This includes:
determining the intended purpose
selecting the correct risk classification
preparing evidence that demonstrates compliance with the safety and performance requirements.
Preparation is key to making sure your product meets Australian requirements. This also helps avoid any regulatory delays. To gauge your readiness, you can request a pre-submission meeting.
Start by learning your responsibilities and planning each stage of your product’s lifecycle.
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.
General information
Learn about how products are regulated.
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DatasetSearch companion diagnostics (CDx) we have approved for supply in Australia.
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PageCheck if your product is a medical device and if it needs to be included in the Australian Register of Therapeutic Goods (ARTG).
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PageLinks to information on IVD medical devices, including HIV and nutrigenetic tests.
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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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PageInformation to assist you with Australia's regulatory framework for medical devices, including in vitro diagnostic (IVD) medical devices.
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GuidanceGuidance on when software is classified as an in vitro medical device and how it is regulated.
Definitions and classification
Understand how products are defined and classified.
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GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
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PageDefinitions of terms and links to other information about the regulation of IVDs.
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PageIntroductory material on in vitro diagnostic (IVD) medical devices
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Decision treeUse this decision tree to work out the classification of the medical device you want to sell or supply in Australia.
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PageMedical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'.
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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LegislationThis Specification facilitates the release of specified therapeutic goods information, relating to in-house in vitro diagnostic (IVD) medical devices, to the National Association of Testing Authorities (NATA).
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LegislationThe Therapeutic Goods (Medical Devices) Regulations 2002 set out the requirements for the registration, classification, and conformity assessment of medical devices in Australia.
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LegislationThe Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020 outlines the specific categories of therapeutic goods that are excluded from the operation of the Therapeutic Goods Act 1989 (Cth).
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LegislationThis Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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FormsTemplates for manufacturers to make Australian Declarations of Conformity for an in vitro diagnostic medical device.
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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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GuidanceThis guidance outlines ARTG and Conformity Assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.
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GuidanceGuidance on how medical devices must comply with the Essential Principles.
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ChecklistsA checklist to help medical device manufacturers demonstrate compliance with the Essential Principles.
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PageWe will recognise the extended transition for the European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR)
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GuidanceGuidance applies to self-tests and point-of-care combo test kits.
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GuidanceGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
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PageInformation on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia.
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PageThe International Medical Device Regulators Forum (IMDRF) promotes an efficient and effective medical devices sector.
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PageGuidance for sponsors and manufacturers of in vitro diagnostic medical devices (IVDs) for use in Australia.
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PageThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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PageMedical devices include a wide range of products such as bandages, syringes, in vitro diagnostic medical devices, surgical lasers, pacemakers and dialysis equipment.
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PageRegulatory information and requirements of nutrigenetic tests supplied in Australia.
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PageAll collection swabs are medical devices and must be included in the Australian Register of Therapeutic Goods (ARTG).
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PageStandards and guidelines for medical devices marketed in Australia.
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GuidanceGuidance on clinical performance requirements and risk mitigation strategies.
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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.
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GuidanceGuidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
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GuidanceGuidance on when software is classified as an in vitro medical device and how it is regulated.
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GuidanceGuidance on our expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for chlamydia, gonorrhoea and syphilis.
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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
Product types