If you're planning to bring an implantable 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 choosing the correct classification, preparing evidence and meeting product standards.
Being well prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
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 implantable medical devices. 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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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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PageInformation about how we regulate medical devices and how to get your medical device approved for use in Australia.
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PageInformation to assist you with Australia's regulatory framework for medical devices, including in vitro diagnostic (IVD) medical devices.
Definitions and classification
Understand how products are defined and classified.
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PageHow medical devices are classified, including in vitro diagnostics (IVDs).
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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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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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GuidanceGuidance to assist sponsors with the reclassification of surgical mesh devices.
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PageLinks to information on laboratory tests, software and AI based medical devices, personal protective equipment (PPE) and implantable 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'.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.
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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LegislationThe Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018 establishes the endotoxin limits for medical devices to minimise risks associated with endotoxin contaminants and residues.
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LegislationThis Specification facilitates the public release of specified therapeutic goods information relating to breast implants.
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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.
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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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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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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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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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GuidanceGuidance on the requirements that specifically apply to active medical devices.
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PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
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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 on the transitional arrangements and obligations of medical devices with a diagnostic function.
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GuidanceGuidance for sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) on transitional arrangements and obligations.
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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 on the transitional arrangements and obligations.
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GuidanceHow the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.
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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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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
Product types