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
Get our instant-download Australian Medical Device Regulations cheat sheet: classification, route to market and labelling essentials in one clear guide, for £15.
