If you're planning to bring a system or procedure pack 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 confirming eligibility, selecting the correct classification and meeting conformity assessment requirements.
Being well prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
Start by learning your responsibilities and planning.
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 medical devices and all products.
General information
Learn about how products are regulated.
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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.
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PageInformation for manufactures and sponsors of medical device systems or procedure packs.
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 sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
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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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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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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 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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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 the regulation of system or procedure packs and using the special conformity assessment procedure.
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GuidanceGuidance on how medical devices must comply with the Essential Principles.
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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.