The Commonwealth of Australia is one of the largest countries in the world, comprising of one large landmass and several small islands located in the Pacific and Indian oceans. Its massive size is home to a variety of landscapes and climates, with most of the population of only just over 20 million people concentrated in the southeast coast. Australia has a highly diverse ecosystem with many species unique to the area. One of the world’s wealthiest nations, Australia is a high-income economy country with a GDP of USD $1.5 trillion in 2013 according to the World Bank.

Australians spent approximately USD $133.8 billion on healthcare in 2015 (9.1% of GDP), most of which was spent by the federal and state/territory governments (according to the Medical Technology Association of Australia’s report). Per capita spending, set at USD $5663 in 2014, has doubled in the last ten years. The local medical device manufacturing market is significant, with over 500 companies operating out of the country.

The Australian government and private healthcare industry have continued to invest relatively heavily in the sector, increasing the number of public and private facilities. While Australians enjoy a publicly funded, universal healthcare scheme, more than half of people living in the country also have private insurance. Despite this, almost 20% of healthcare spending is out-of-pocket and the number is expected to increase as the population ages and life expectancy continues to exceed the OECD average for both women and men. Most medical technology is imported into Australia, though the local market made more than USD $10 billion in 2011-12.

Though growth is expected to slow over the next five years, the Australian medical device market is among the 20 largest in the world, estimated at USD $903.9 million by Espicom in 2015. In the same report from early this year, Espicom also rates the Australian market as the second most attractive in the Asia Pacific region, with a 5.6% increase in medical device imports between July and October of last year that was focused mainly in the diagnostic imaging and patient aids market.

THE GOOD NEWS:

Most devices can be registered in Australia in less than 8 weeks.

THE CHALLENGE:

Devices and accessories must be registered separately and any device may be subject to a full review either due to the safety or risk of the product or by the random selection of the TGA.

All medical and IVD devices in Australia are registered through the Therapeutic Goods Administration (TGA), including accessories. Similar to the EU risk-based regulatory system, Australian certification is recognized around the world as one of the top certifications for MedTech.

Most devices are registered through a standard process that takes 4 to 8 weeks. However, some devices must undergo a full technical review, which will extend timelines to as much as 6 to 8 months and raise costs considerably. Device types that will automatically undergo full review include in vitro diagnostic (IVD) devices intended for use in point of care units, Class 3 devices, and some Class 2B devices, though the TGA will also randomly select devices for review even after a license as granted as part of their post-marketing policy. Some devices, including the most high-risk devices, may be selected for full review based on risk or other safety concerns according to the discretion of the TGA. Manufacturers should note that in vitro diagnostic devices (IVD) have a stricter review process in Australia than most other countries.

The Australian TGA processes regular submission very quickly so long as all required documents are compiled and submitted correctly. It is important to consider that every accessory that is not included in the main application and is intended to be sold separately must have a separate license. An authorized representative is required for a foreign manufacturer to initiate the application.

The TGA’s requirements for the technical dossier are very similar to requirements in the EU. A CE Mark should be submitted with the technical dossier to ensure smooth registration and can expedite the review process. If a CE Mark is not available, or if the device is ranked in the highest-risk categories, the manufacturer will be audited by the Australian authorities in order to ensure compliance. Australia may also recognize conformity assessments from Canada and other systems. All documents must be submitted in English through the online TGA-eBS system.

Once issued, licenses in Australia are permanent and subject to an annual fee. During this time, the device must carry a valid EC certificate and other information such as distribution records. Manufacturers of AIMD, Class 3, and implantable Class 2B devices should submit three consecutive annual reports to the TGA summarizing adverse events or complaints related to the device in order to maintain their license.

WHAT YOU NEED TO KNOW:

Australia’s medical device requirements are similar to the EU and licenses are issued quickly if all information is prepared properly and the device carries a CE Mark. Once issued, licenses must be maintained through an annual fee, though full technical reviews may be required by the TGA as part of their post-marketing policy.