Australia has a relatively large population in tandem with an increasingly aging population, which makes a good case for increased demand of medical devices. Furthermore, the incidence of more chronic diseases also supports this point. Another fact to note is that healthcare expenditure has also been on the rise, increasing from $180.40 billion in 2015 to $195.70 billion in 2018. The Australian medical device industry is also friendly to innovation, making it a good opportunity for manufacturers with novel devices.
Medical device regulatory requirements are overseen by the Therapeutic Goods Administration (TGA) and listed products can be viewed on the Australia Register of Therapeutic Goods (ARTG). Most foreign companies will seek registration through the abridged route by providing evidence of previous approval from the following entities:
EU designated Notified Body
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)
Foreign manufacturers will need to coordinate with an Australian Sponsor, like Asia Actual, to facilitate the application process.
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Asia Actual is available to help navigate the medical device registration requirements and regulatory pathway for medical device and IVDs in Australia.
Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the Australian market.