Medical Devices
Bringing a medical device to the Australian market means navigating the Therapeutic Goods Administration (TGA), inclusion on the Australian Register of Therapeutic Goods (ARTG), and ongoing compliance obligations.
At Taylored Consultancy Ltd, we cut through the confusion and provide clear, commercially focused regulatory support to help you launch with confidence. Whether you need help with technical documentation, product classification, or appointing an Australian Sponsor, we make sure your device meets TGA requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your medical devices listed on the ARTG, compliant, and trusted.
Unsure how your product is classified? We determine the correct classification under the Australian system (Class I to III and AIMD), ensuring you follow the right regulatory pathway.
We conduct a full regulatory gap analysis against Australian requirements to identify any missing or incomplete documentation.
If your device comes into contact with the body, it needs biocompatibility testing. We help you identify the right testing requirements and ensure results are documented correctly.
We help compile and review clinical evidence to support your application for ARTG inclusion, including leveraging comparable overseas (CE / FDA) approvals where accepted.
We help you assemble the manufacturer's evidence the TGA requires, whether through TGA conformity assessment certification or comparable overseas regulator routes.
We review your labels and instructions for use against TGA requirements, including the new Australian UDI framework.
We manage your application for inclusion on the ARTG, ensuring your product is correctly listed before it enters the market.
If you're an overseas manufacturer, you must appoint a local Australian Sponsor to hold your ARTG entry. We can act as, or help you appoint, your Sponsor so your device stays compliant.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 13485 - Medical devices
ISO 9001 - General
ISO 14971 - Risk management for medical devices
ISO 10993 - Biocompatibility
IEC 60601 - Electrical safety and electromagnetic compatibility for medical devices
ISO 11135 - Ethylene oxide sterilisation of medical devices
ISO 11607 - Packaging for terminally sterilised medical devices
ISO 15378 - Primary packaging materials for medicinal products
ISO 14155 - Clinical investigation conduct
EN 62304 - Software within a medical device
IEC 61326 - EMC requirements for electrical equipment
ISO 15197 - Blood glucose monitoring systems
MDSAP - Medical Device Single Audit Programme
Yes. If you're a manufacturer based outside Australia, you're legally required to appoint an Australian Sponsor, a locally based entity who takes on responsibility for your device with the TGA, including ARTG inclusion, vigilance and being the local point of contact. Without a Sponsor in place, your device simply can't be included on the ARTG, so it's one of the earliest things to sort out when planning an Australian launch. We act as Sponsor for manufacturers who don't have an Australian presence.
ARTG inclusion is the process of getting your device listed on the Australian Register of Therapeutic Goods, which is the TGA's official record of medical devices legally allowed to be supplied in Australia, and you can't sell a device in Australia without it. Getting there means confirming classification, assembling conformity assessment evidence, and applying through your Australian Sponsor, with the level of evidence required scaling with your device's risk class.
Often, yes. The TGA recognises certain overseas conformity assessment certificates, including CE marking issued under EU MDR, as evidence for ARTG inclusion for many device classes, which can significantly cut the work needed compared to a from-scratch Australian assessment. It's not automatic for every device or class though, so it's worth checking which parts of your existing CE technical file the TGA will actually accept before assuming it carries straight across.
Australian medical devices are classified using a risk-based system running from Class I through to Class III, plus a separate category for active implantable medical devices (AIMDs), based on factors like invasiveness, duration of use and whether the device is active, closely mirroring the approach used in the EU. Your class determines the conformity assessment route available to you and how much clinical and technical evidence the TGA expects to see.
A TGA Sponsor is the Australian entity legally responsible for a device once it's on the ARTG, handling registration, vigilance and TGA communication, while a Notified Body is a separate, EU-based organisation that independently assesses higher-risk devices against EU MDR requirements before CE marking. They're not interchangeable: a Sponsor is about who's accountable in Australia, a Notified Body is about who's assessed your device's conformity in Europe.
Yes, most devices supplied in Australia need to comply with the TGA's Unique Device Identification framework, which assigns a UDI to help track devices through the supply chain and support safety monitoring and recalls. The framework is being phased in by device type and risk class rather than applying to everything at once, so which UDI obligations currently apply depends on your specific device.
Still have questions? Contact us and we'll be happy to help.
