Steps to Market your Medical Device in the Australian Market

Steps to Market your Medical Device in the Australian Market

Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how do you get there?

Marketing your medical device in the Australian market requires compliance with the Therapeutic Goods Administration (TGA), which is Australia’s regulatory body. The first step in this process is to identify if your product is a medical device that requires inclusion in the Australian Register of Therapeutic Goods (ARTG). To obtain that answer, you need to ask yourself the following:

  • Is your product a medical device or IVD medical device?
  • Has your product been declared not to be a medical device?
  • Is your product a good that has been excluded from regulation?
  • Is your product exempt from inclusion in the ARTG?
  • Is your product a therapeutic good rather than a medical device?1

Once you have a better understanding of whether your device is a medical device or not, you can move to the next step of determining the classification of the medical device you are marketing.

TGA has a risk-based approach to the regulation of medical devices. It is known around the world that someone shouldn’t compare the regulations between an elastic bandage to a pacemaker due to the complexity and high risk of the device. However, every country is slightly unique in the classification of their medical devices.

Australia holds five classifications of medical devices that include: class I, class IIa, class IIb, class III, and active implantable medical devices. Class I are low-risk devices like scalpels. Class IIa are low-medium risk devices like hearing aids.2 Class IIb are medium-high risk devices like dressings for severe wounds and condoms. Class III is specific to high-risk devices like intrauterine contraceptive devices and any medical devices that contain medicine such as dressings with an anti-microbial agent. Active implantable medical devices are devices like pacemakers and cochlear implants.3 Understanding the correct classification for your medical device can save you time and money in the regulation process.

The final step in commercializing your product in Australia is conducting a conformity assessment. The manufacturer applies the conformity assessment procedure to generate evidence to demonstrate the safety, quality, and performance of a device.

Marketing your medical device in another country can bring you more opportunities to grow your business, but it can be tricky. EMMA International can help you expand your market to Australia or any other country! Contact us at 248-987-4497 or email info@emmainternational.com to see how we can help.


1Australian Government Department of Health (11 October 2019) “Medical Device Inclusion Process – Steps in the process” retrieved on (01 January 2020) from https://www.tga.gov.au/book-page/step-1-your-product-medical-device-or-ivd-medical-device-requires-inclusion-artg

2Pharm Out (2016) “How to register a medical device in Australia” retrieved on (01 January 2020) from https://www.pharmout.net/downloads/white-paper-how-to-register-a-medical-device-in-australia.pdf

3Australian Government Department of Health (18 November 2011) “The regulation of medical devices – Behind the news” retrieved on (01 January 2020) from https://www.tga.gov.au/behind-news/regulation-medical-devices

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