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.
Pure Global simplifies the process with AI workflows that accelerate TGA registration, along with local support and representation, all for a flat annual fee.
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 TGA Sponsor includes ARTG registration and more for an annual flat fee.
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.
Pure Global offers flat-fee annual pricing for bundled TGA Sponsor services and regulatory support in Australia, starting at $2,000/year. The flat fee includes document review, ARTG registration, and Certificate of Free Sale (CFS) processing. Government and other third party fees, when applicable, are not included.
Flat fee structure for medical devices and IVDs:
1 device or device group = $2,000/year
2-5 devices/groups = additional $500 per device per year (e.g., 5 devices = $4,000/year)
6-10 devices/groups = no additional cost (e.g., 8 devices - $4,000/year)
Contact us for a custom quote if you have 11+ devices.
A three-year contract is required to lock in the fees quoted above. However, other contractual arrangements are available. Use our Fee Calculator for an instant estimate and more information about flat fee terms.
TGA charges mandatory government fees based on device classification and submission type, with fees assessed per product. There are one-time application fees and recurring annual charges once a product is included on the ARTG.
One-time application fees apply to medical device registrations:
Annual fees apply by risk class:
For in vitro diagnostics (IVDs):
All fees listed are government fees only and do not include consulting services, dossier preparation, conformity assessment activities, testing, or regulatory representation. Fees can change without notice.
Check our Fee Calculator for up-to-date government fees in 14 markets.
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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