If you're planning to bring a medical device to market in Australia, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage.
This includes:
determining whether your product meets the definition of a medical device
determining whether any exclusions or exemptions apply
choosing the correct classification
preparing evidence
meeting product standards
Being well prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
Start by learning your responsibilities and the regulatory requirements that apply to your device.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all products.
General information
Learn about how products are regulated.
-
PageCheck if your product is a medical device and if it needs to be included in the Australian Register of Therapeutic Goods (ARTG).
-
PageSteps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
-
PageInformation about how we regulate medical devices and how to get your medical device approved for use in Australia.
-
PageInformation to assist you with Australia's regulatory framework for medical devices, including in vitro diagnostic (IVD) medical devices.
-
PageOverview of the way we consider risks and benefits during the evaluation and post-market monitoring of products.
Definitions and classification
Understand how products are defined and classified.
-
PageHow medical devices are classified, including in vitro diagnostics (IVDs).
-
GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
-
Decision treeUse this decision tool to help you determine if your product is a medical device.
-
PageLinks to information on laboratory tests, software and AI based medical devices, personal protective equipment (PPE) and implantable medical devices.
-
PageAdvice about systems that are medical devices for sponsors and manufacturers.
-
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.
-
PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
-
PageA list of medical device notices and standards orders.
-
LegislationThis Instrument makes various amendments to the Therapeutic Goods Advertising Code.
-
LegislationThe Therapeutic Goods (Charges) Act 1989 regulates the fees associated with the registration and listing of therapeutic goods in Australia.
-
LegislationThis instrument specifies classes of therapeutic goods for the purpose of section 23A of the Therapeutic Goods Act 1989.
-
LegislationThis Order clarifies whether specified goods or classes of goods are therapeutic goods according to the terms of the definition of 'therapeutic goods' in the Therapeutic Goods Act 1989.
-
LegislationThis Specification facilitates the public release of specified therapeutic goods information relating to exemptions that do or do not apply under the Annual Charges Exemption Scheme.
-
LegislationThe Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Amendment Order 2024 establishes quality and safety requirements for therapeutic vaping devices in Australia.
-
LegislationThese Rules specify circumstances in which a health practitioner is authorised to supply specified medical devices which are not included in the Australian Register of Therapeutic Goods (ARTG), under the TGA's Special Access Scheme category C pathway.
-
LegislationThis Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
-
LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
-
FormsOnline application form to become an Australian Conformity Assessment Body.
-
GuidanceAn overview on the application process for manufacturers aiming to obtain a TGA-issued Conformity Assessment certificate.
-
GuidanceGuidance to assist Australian corporations seeking to apply for an Australian Conformity Assessment Body (CAB) determination for medical devices (including IVDs) by the TGA.
-
PageAustralian corporations can now apply to become an Australian Conformity Assessment Body (Australian CAB)
-
User guideHow to successfully complete and submit an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
-
GuidanceGuidance on how medical devices must comply with the Essential Principles.
-
PageWhat you need to submit to include medical devices in the ARTG, including IVDs.
-
ChecklistsA checklist to help medical device manufacturers demonstrate compliance with the Essential Principles.
-
PageOverview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework.
-
PageWe will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).
-
FormsInformation and forms about applications for TGA Conformity Assessment certificates.
-
PageA medicinal substance in a medical device must meet Australian manufacturing and quality control requirements.
-
PageUse our online assessment tool and notification form to transition to the new EU MDR, so you can continue supplying medical devices.
-
PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
-
PageThe Australian medical devices legislation creates a system of non-mandatory medical device standards orders (MDSO) and Conformity Assessment standards orders (CASO) that can be used to demonstrate compliance.
-
User guideHow to view and respond to notifications related to an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
Product types