If you’re planning to supply a medical device in Australia, you must comply with the Therapeutic Goods Administration (TGA) requirements and have your product included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally marketed.
In this blog post, we will walk you through the step-by-step process for medical device registration in Australia in 2025 — from device classification to post-market obligations — so you can navigate TGA regulations with confidence.
Medical Device Registration in Australia: Step-by-Step Guide[2025 Updated]
Here are 7 steps to register medical device in Australia. Let’s have a look.
Step 1: Determine If Your Product Is a Medical Device
Before starting the registration process, confirm whether your product meets the definition of a medical device under Australian law. This includes:
- Instruments, apparatus, machines, implants, reagents, and software used for medical purposes.
- Devices for diagnosis, prevention, monitoring, treatment, or alleviation of disease.
If unsure, OMC Medical can assist in determining classification or even apply to the TGA for a ruling on your behalf.
Step 2: Classify Your Medical Device
The TGA uses a risk-based classification system similar to the EU MDR:
- Class I (low risk) – e.g., bandages.
- Class IIa & IIb (medium risk) – e.g., infusion pumps.
- Class III (high risk) – e.g., implantable pacemakers.
- IVDs – separate classification rules for in vitro diagnostic devices.
Correct classification is crucial, as it impacts documentation, fees, and approval timelines. OMC Medical ensures your device is classified accurately to prevent application rejections.
Step 3: Appoint an Australian Sponsor
If you are an overseas manufacturer, you must appoint a TGA-recognized Australian Sponsor.
The sponsor acts as your local representative and is responsible for:
- Submitting the ARTG application.
- Liaising with the TGA.
- Ensuring ongoing compliance and post-market vigilance.
OMC Medical offers Australian Sponsor services, managing the entire compliance lifecycle for you.
Step 4: Prepare Evidence of Conformity
You must provide evidence that your device meets the Essential Principles for safety and performance. This may include:
- TGA Conformity Assessment (direct evaluation) or
- Mutual Recognition (using approvals from EU, Canada, Japan, or other recognized regulators).
OMC Medical advises on the most time-efficient and cost-effective pathway for your product.
Step 5: Compile Technical Documentation
Technical documentation should cover:
- Device description and specifications.
- Design, manufacturing, and risk management details.
- Clinical evidence and performance data.
Our regulatory experts at OMC Medical prepare, review, and organize your documentation to meet TGA’s strict standards.
Step 6: Submit Your ARTG Application
The application process involves:
- Lodging your application via the TGA Business Services (TBS) portal.
- Paying the applicable application and assessment fees.
- TGA review and possible requests for additional information.
Once approved, your device will be listed in the ARTG, allowing legal supply in Australia. OMC Medical handles this process end-to-end.
Step 7: Meet Post-Market Obligations
After approval, you must:
- Maintain QMS compliance.
- Report adverse events to the TGA.
- Keep records of complaints and corrective actions.
- Update the ARTG if there are changes to the device.
OMC Medical offers post-market surveillance support to ensure you remain fully compliant.
Conclusion
Registering a medical device in Australia requires precision, correct classification, and robust documentation. Whether your device requires a TGA Conformity Assessment or can leverage overseas approvals via Mutual Recognition, having an experienced partner like OMC Medical Limited can save you time, reduce costs, and ensure a smooth approval process.
📩 Contact OMC Medical Limited to streamline your medical device registration process in Australia and ensure full compliance.
