TGA Australia Medical Device Registration & Approval
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.
Understanding Device Classifications and Regulatory Requirements in Australia
Regulatory Authority
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.
Classification
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.
Key Requirements
Foreign manufacturers without an Australian entity must appoint an in-country representative, or an Australian Sponsor, who is responsible for:
- Ensuring products are classified correctly according to the regulatory pathway.
- Submitting applications to include the products in the Australian Register of Therapeutic Goods (ARTG) before they can be marketed.
Tailored Support for Market Entry
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.
Frequently
Asked Questions
Does CE Marking in Europe make it easy to register my medical device in Australia?
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.
Is Australia medical device classification identical to the EU MDR?
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.
What is a TGA medical device 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.
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