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 enhance clinical outcomes, expedite patient recovery, reduce healthcare costs, and address chronic pain and disability. TGA Australia medical device registration and approval are required to import products to Australia.
Australia’s medical devices market will reach $10.56B by 2034 (6.3% CAGR), and the IVD market$2.54B by 2030 (5.36% CAGR). Growth is driven by rising healthcare spending (10.2% of GDP), an aging population (16.8% 65+ in 2021), and a strong medtech workforce (18,880 jobs in 2025).
Medical devices sold in Australia are regulated by the Therapeutic Goods Administration (TGA). Pure Global can assist with Australia medical device registration and act as your Australian Sponsor, ensuring TGA approval to sell in the Australian market.
In Australia, medical devices are classified according to the level of risk they present, similar to the EU's system. The TGA’s regulatory approach facilitates market entry for devices with CE certification, with special attention to high-risk devices through additional reviews.
Foreign manufacturers without an Australian entity must appoint an in-country representative, or an Australian Sponsor, who is responsible for:
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.
Yes. TGA recognizes authorizations in other major markets, like the US and Europe. However, you still need to register with the TGA and receive an ARTG listing number to legally sell your device in Australia. If your device is high risk, it may also require a TGA application audit.
Yes and no. Australian classification rules mirror EU classification and, in most cases, classification in Australia will match your device’s EU classification. However, there are exceptions, so it’s important to always confirm your device’s classification according to Australia’s rules before moving forward with your application. If there is a classification discrepancy, it can cause delays with your registration and perhaps result in an application audit.
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.
Contact us
