Australia

Australia Medical Device Market

Regulatory oversight of medical devices in Australia falls under the Therapeutic Goods Administration (TGA), with listed products accessible on the Australia Register of Therapeutic Goods (ARTG). Foreign companies typically pursue registration through an abridged pathway by demonstrating previous approvals from recognized entities:

• EU designated Notified Body
• US FDA
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA), or a Registered Certified Body (RCB)
• Medical Device Single Audit Program (MDSAP)
• Singapore Health Sciences Authority (HSA)

Foreign manufacturers must collaborate with an Australian Sponsor, such as Asia Actual, to facilitate the application process effectively.

Why Register your Medical Device in Australia?

Australia’s substantial and aging population, coupled with an increasing prevalence of chronic diseases, underscores a growing demand for medical devices. Healthcare expenditure in the country has risen significantly from $180.40 billion in 2015 to $195.70 billion in 2018. Australia’s medical device industry fosters innovation, presenting favorable opportunities for manufacturers of novel devices.

Grow With Us

Asia Actual Australia is headquartered in Sydney and managed by regulatory expert, Jack Liang. Jack and his team are available to help you navigate the medical device and IVD registration requirements and regulatory pathways in Australia.

Contact Asia Actual for a free consultation on the market access potential of your medical device or IVD in Australia.