The medical devices market in Australia is growing steadily, driven by an aging population, the expansion of healthcare technologies and increased demand for quality care. It represents a strategic opportunity for international companies wishing to establish themselves in a regulated, dynamic and innovation-driven environment. Australia offers stable, transparent and solvent access for medtech companies wishing to expand into the Asia-Pacific region.
Australia has one of the most efficient healthcare systems in the world, with healthcare spending representing more than 10% of its GDP. The country imports the majority of its medical devices, making it an attractive entry point for foreign players.
With evolving medical and technological needs, certain segments stand out. These are in high demand from hospitals, private clinics, and specialized medical providers, and present strong opportunities for French companies.
In vitro diagnostics (IVD), particularly for infectious and chronic diseases
Orthopedic implants and cardiovascular devices
Robotic or augmented-reality-assisted surgical equipment
Connected technologies (wearables, remote monitoring, medical IoT)
Home care and rehabilitation solutions
Products related to active ageing and pain management
Exporting medical devices to Australia requires a strong understanding of local regulations. The market is overseen by the Therapeutic Goods Administration (TGA), which ensures high levels of safety and efficacy.
Device classification: from Class I (low risk) to Class III (high risk)
Registration through the Australian Register of Therapeutic Goods (ARTG)
Requirement of a local sponsor based in Australia
Partial recognition of CE certifications possible
Mandatory post-market surveillance, including incident reporting obligations
The Australian distribution model is a combination of public procurement, private players, and specialized networks. Understanding this structure is key to choosing the right partners and succeeding in the market.
Agreements with local distributors specialized in medical devices
Registration with public hospitals (State Health Procurement) or private hospitals
Sales through specialized clinics, healthcare chains, or rehabilitation centers
Online development via B2B platforms or specialized suppliers
Tenders: each Australian state has its own procedures
Australia values European technological expertise and regulatory rigor. French and francophone companies enjoy a reputation for quality and innovation, particularly in high clinical value segments.
CE-certified devices with functional differentiation
Products originating from hospital-university or biotech research
Software innovations and connected patient monitoring devices
Solutions for managing chronic diseases and dependency
Niche products for pediatrics, rehabilitation, or preventive medicine
For more than 15 years, Expandys has supported medtech companies in their market development strategies in Australia. Thanks to our local expertise, medical network, and deep understanding of regulatory challenges, we help companies establish a sustainable presence.
We offer:
👉 Contact the Expandys team to structure your access to the Australian market.