Australia medical device registration requirements include listing in the Australian Register of Therapeutic Goods (ARTG) before they can be legally distributed. The Therapeutic Goods Administration (TGA) regulates this process and requires foreign manufacturers to appoint an Australian Sponsor to submit the application and act as the regulatory liaison. Low-risk devices may be eligible for self-certification, while higher-risk devices must undergo full conformity assessment.
Australia, with a population exceeding 25 million, is a significant import market for medical devices and diagnostics, with around 80% of its market needs met through imports mainly from the United States, China, and Germany. The market is particularly receptive to innovative products that expedite patient recovery, reduce healthcare costs, and address chronic pain and disability.
Confirm the device classification according to TGA’s risk-based system to determine Australia medical device registration requirements. Conduct conformity assessments as required by the Australian Regulatory Guidelines for Medical Devices (ARGMD), leveraging market reference approvals from the USA, Canada, or EU if applicable.
Prepare a comprehensive technical file dossier in accordance with TGA standards and relevant device-specific requirements.
If the manufacturer does not have a local presence in Australia, appoint an in-country representative known as an Australian Sponsor to facilitate TGA medical device registration. Assign local distributors or importers as needed.
Submit a complete application to TGA for Manufacturer Evidence approval and Device Inclusion in the Australian Register of Therapeutic Goods (ARTG). Pay the applicable government fees.
TGA reviews the application and may request additional documentation. Some applications may be selected for audit, depending on device risk and regulatory history.
Comply with Australia medical device registration requirements by implementing and maintaining a robust post-market surveillance system, including adverse event reporting and ongoing regulatory compliance. ARTG listings do not expire but do require an annual fee; supporting certificates (such as a CE Certificate) must be kept current. TGA conformity assessment certificates expire every five years.
Our specialized services in the Australian market include:
Determining the classification and grouping of your products to identify the correct regulatory pathway.
Preparing and compiling the necessary technical dossier for the TGA registration process.
Acting as your Australian Sponsor, handling the TGA submission on your behalf, and ensuring compliance with post-market requirements.
For most devices up to Class IIb, the timeline is typically 4–6 weeks, including dossier compilation. Class III and AIMDs may take around 6 months, though total time varies based on TGA requests and possible audits.
Registration costs typically range from $4,000 to $8,000 USD depending on device classification and whether market reference approvals are used. Additional government fees of $1,000 to $2,000 USD may apply, excluding testing or certification costs.
An application audit (also called a technical file review) is when TGA conducts a thorough review of your technical documentation. TGA marks certain devices (such as specific IVDs) that automatically require an application audit, though it can select any ARTG application for review. If your device or application requires an application audit, the TGA will notify you and you must pay a fee.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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