Leveraging Opportunities in the Australian Medical Device Market

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.

Device Classification and Regulatory Pathways

Understanding Device Classifications and Regulatory Requirements in Australia

Regulatory Authority

The Therapeutic Goods Administration (TGA) oversees the medical equipment industry in Australia, operating under a regulatory framework aligned with IMDRF guidelines. This harmonization means that EU-certified devices (CE marked) are largely accepted, though the TGA also recognizes FDA regulatory clearance in conjunction with a MDSAP certificate. For high-risk devices, including implants, TGA conducts further evaluations before allowing registration.

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.
How We Can Help

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.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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