Bringing a new medical device to market starts with early-stage work like product design and testing. It is worth considering how you will meet your regulatory obligations as part of your initial design process.
You may need clinical data to prove safety and performance. This is especially true for higher-risk devices.
Strong research and development will help you meet regulatory requirements, get market entry and build consumer trust.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about medical devices, and specific types of medical devices. You may also have to meet obligations that apply to all products.
Application pathways and processes
Find application routes to market approval.
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FormsInformation and links to the medical devices priority applicant determination application form.
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PageThe ARGMD will help you navigate the regulatory requirements for medical devices in Australia.
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PageChanges to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG.
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PageTo help sponsors understand and meet their ongoing regulatory obligations after consent to supply is granted and throughout the consent period.
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GuidanceGuidance to understand if your medical device product should be in the Australian Register of Therapeutic Goods (ARTG).
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PageThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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PageSteps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
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PageRegulatory Engagement meetings can help with understanding the medical device or IVD. We will discuss your supporting information for an application and issues that may arise before your submission.
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PageMedical devices priority applicant determination notices and eligibility for priority review pathway.
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PageOur goal is to harmonise with other jurisdictions (and international standards where necessary).
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PageOverview of the process to follow if you want to supply therapeutic goods in Australia
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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).
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PageFind out when an application audit may be conducted and understand the audit assessment process.
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PageMedical device priority review information and application form.
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PageInformation about the application process and forms.
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PageGuidance on legally supplying medical devices in, and exporting them from, Australia.
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PageThis instrument is made under subsection 41FDB(2) of the Act.
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LegislationThis Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.
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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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GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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PageUpdate to information about applying for assessment of a COVID-19 test for inclusion in the ARTG.
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PageThe ARGMD will help you navigate the regulatory requirements for medical devices in Australia.
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PageNew information about importing self-tests.
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PageThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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PageRegulatory Engagement meetings can help with understanding the medical device or IVD. We will discuss your supporting information for an application and issues that may arise before your submission.
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PageInformation for applicants on how to request and prepare for pre-submission meetings.
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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).
Fees and charges
Understand fees, exemptions and how to make payments.
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PageInformation for sponsors who want to estimate when annual charges will become payable after therapeutic goods generate a turnover and are no longer ACE eligible.
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PageThe Annual Charge Exemption (ACE) scheme provides an exemption from annual charges until a product first generates a turnover.
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PageInformation about annual charges for product entries on the Australian Register of Therapeutic Goods (ARTG) and manufacturing licences.
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GuidanceGuidance about the Annual Charge Exemption (ACE) scheme waiver process.
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PageThe following forms are for the use of sponsors and manufacturers mainly regarding the payment of fees and charges.
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PageAccess to information about fees and payments.
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PageAnnual charges for a licence to manufacture a therapeutic good may be reduced by 50% if the wholesale turnover of that good is below a prescribed level.
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Global Medical Device Nomenclature
Access the correct GMDN terms for devices.
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PageFind out about Global Medical Device Nomenclature (GMDN) Terms, which are an international naming and grouping convention used to identify and consistently describe medical devices.
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GuidanceGuidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.
Product changes and variations
Access information to vary products and sponsorship.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
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GuidanceGuidance for what to do if the sponsor of a therapeutic good changes.
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
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FormsUse this form to request reinstatement of a cancelled entry on the Australian Register of Therapeutic Goods.
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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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User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.
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User guideHow to withdraw your Australian Register of Therapeutic Goods (ARTG) application, for medical device sponsors (includes importers and exporters).
Product types