Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.
The Therapeutic Goods (Medical Devices) Regulations 2002 were established under the Therapeutic Goods Act 1989.
These regulations set out the requirements for the registration, classification, and conformity assessment of medical devices in Australia.
They aim to protect public health and safety by ensuring that medical devices meet essential standards before they can be marketed and used.
Guidance referring to this legislation
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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GuidanceGuidance on how medical devices must comply with the Essential Principles.
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GuidanceGuidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
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GuidanceInformation about how Clinical Decision Support System (CDSS) software is regulated, including when they are and are not exempt from inclusion on the ARTG.
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GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
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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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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).
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GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.
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GuidanceGuidance for manufacturers to help you manage risks and meet regulatory requirements.
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GuidanceGuidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.
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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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GuidanceGuidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.
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GuidanceGuidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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GuidanceThis guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024. It helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.
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GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
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GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
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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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GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
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GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
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GuidanceGuidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).
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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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GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
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GuidanceGuidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
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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 manufacturers outlining the procedures for submitting conformity assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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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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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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GuidanceGuidance on the transitional arrangements and obligations of medical devices with a diagnostic function.
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GuidanceGuidance for making an offer of enforceable undertaking to us.
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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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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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GuidanceGuidance applies to self-tests and point-of-care combo test kits.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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GuidanceGuidance to assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA.
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GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
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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 to explain what we need for software and apps that work with COVID-19 rapid antigen tests.
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GuidanceThis guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
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GuidanceGuidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
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GuidanceGuidance on clinical performance requirements and risk mitigation strategies.
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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 for the requirements applicable to medical devices containing poisons.
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GuidanceGuidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
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GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations
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GuidanceGuidance to understand how we interpret regulations and how manufacturers can comply with them.
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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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GuidanceThis guidance helps providers of digital mental health services or products to understand their regulatory obligations.
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GuidanceGuidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
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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 for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special Conformity Assessment procedure.
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GuidanceGuidance to assist sponsors with the reclassification of surgical mesh devices.
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GuidanceGuidance for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
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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 to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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GuidanceGuidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
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GuidanceGuidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
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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 how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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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 the requirements that specifically apply to active medical devices.
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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 how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceGuidance on reporting adverse events for sponsors of medical devices.
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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GuidanceFrom 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.
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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
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GuidanceGuidance on interpretation of software exclusion criteria to understand the boundaries between software that is and is not regulated.
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GuidanceGuidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).
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GuidanceThis guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply.
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GuidanceGuidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.
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GuidanceGuidance on the transitional arrangements and obligations of sponsors and manufacturers.
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GuidanceGuidance to assist sponsors of medical devices that administer medicines or biologicals by inhalation meet their obligations and comply with regulations
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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.
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GuidanceThis guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations.
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GuidanceGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
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GuidanceGuidance explaining sponsor requirements for IVD conformity assessment through manufacturer agreements and regulatory compliance.
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GuidanceGuidance on clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza.
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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