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Deviceology is uniquely positioned to assist clients in navigating the complexities of the Australian Medical Devices market. Leveraging our extensive expertise in international regulations and ISO standards, such as ISO 13485 for quality management, we offer a comprehensive suite of services that facilitate market entry.


Our team provides invaluable guidance on regulatory compliance, ensuring that your medical devices meet the stringent requirements set forth by the Therapeutic Goods Administration (TGA) in Australia. We also offer insights into the Medical Device Single Audit Program (MDSAP), enabling U.S. manufacturers to use FDA regulatory clearance information for a smoother approval process in Australia.

Moreover, Deviceology understands the market dynamics and consumer demands in Australia, which is crucial for successful market penetration. We offer market research services that identify potential gaps in the market, as well as areas of growth—such as cardiology and orthopedic devices, which are seeing increased demand due to Australia's ageing population.


Our end-to-end solutions, from market research to market launch, are designed to not only meet regulatory and internatinal standards but also to align with Australia's healthcare policies and expenditure patterns. By partnering with Deviceology, clients can expect a streamlined, compliant, and strategic entry into the lucrative Australian Medical Devices market.

Market Data

Medical Devices Market Valuation


Medical Device products serving Australia's aging population  

Growing demand for Medical Device products that improve clinical outcomes and have differentiated capabilities.

2021: $4.78 billion

2023: Projected $6.34 billion

2028: Projected $8.52 billion

Market Segmentation

Cardiology Devices: Largest sub-market,  projected  $0.92 billion in 2023.

Other Segments:      Diagnostic Imaging, Orthopedic Devices, Ophthalmic                                              Devices, General & Plastic Surgery Devices.

Healthcare Expenditure

9% of Australian GDP

Australian state government spending accounts for 70% of total healthcare expenditure.

Market Dynamics

Approximately 80% of domestic demand is met by imports.


The U.S. is the largest supplier, accounting for 32% of Australia’s imports.


There is a growing demand for products that lead to faster patient recovery, reduce healthcare costs, and manage chronic pain.

Contact us to discuss your access requirements for the Australian Medical Device market

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