WHY MEDTECH COMPANIES ARE TAPPING INTO THE AUSTRALIAN MARKET

Australia has become a prime target for MedTech companies looking to expand into new markets. Thanks to recent regulatory harmonization reforms, Australia offers a straightforward regulatory pathway for manufacturers holding certifications from regions like the United States (U.S.) and European Union (EU).

Regardless of whether companies leverage existing certifications, they must have a clear understanding of Australia’s medical devices regulations to achieve compliance and gain a competitive advantage.

In this ebook, we outline the key requirements and steps for obtaining medical device certification and market approval in Australia. We also explore how a proven cloud quality management system (QMS) can help streamline the process.

Australia has become a prime target for MedTech companies looking to expand into new markets. Thanks to recent regulatory harmonization reforms, Australia offers a straightforward regulatory pathway for manufacturers holding certifications from regions like the United States (U.S.) and European Union (EU).

Regardless of whether companies leverage existing certifications, they must have a clear understanding of Australia’s medical devices regulations to achieve compliance and gain a competitive advantage.

In this ebook, we outline the key requirements and steps for obtaining medical device certification and market approval in Australia. We also explore how a proven cloud quality management system (QMS) can help streamline the process.

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).

*Source: https://pureglobal.com/markets/australia