Deep Dive in the Asia Pacific Medical Device Market – Australia

by | Jan 9, 2024 | IMed Consultancy, New Markets

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Welcome back to our articles dedicated to emerging market access. This time we’ll further explore Asia Pacific, that is the fastest-growing region in the global medical devices market and was worth over $105 billion (USD) in 2022!

We already looked at market access in some Asia Pacific markets such as India and China in our articles, with these new blogs we’ll take a quick look at a few more Asia Pacific countries, offering an overview of market access for Medical devices. This article is dedicated to Australia.

Australian Regulatory Guidelines for Medical Devices

Medical devices imported and sold into Australia must registered or listed on the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Australian Therapeutic Goods Administration (TGA). The Australian Regulatory Guidelines for Medical Devices (ARGMD) provides information on the import, export and supply of medical devices within Australia.

TGA recognises other regulatory agencies market authorisations (including the EU CE marking certificate and US FDA clearance). Regardless of this recognition the device must still be registered with the TGA and receive an ARTG listing number. ISO13495:2016 or MDSAP certification is required.

Australian classification rules are generally aligned with the EU system and criteria (Class I, IIa, IIb and III), however classification should always be confirmed according to Australian classification rules.

There is an ongoing project within the TGA to reform the low-risk product requirements to remove unnecessary regulation while still ensuring devices are appropriately regulated. Currently Class I non-sterile, non-measuring devices require just the manufacturer’s declaration of conformity submitted with the formal application for the inclusion in the ARTG database.

Australia Market Access Summary:

  • Determine the classification of your device according to the Australian classification rules. (this can be done using the TGA online assessment tool and or the official guidance)
  • Appoint an Australian Sponsor to manage your device registration and interact with the TGA on your behalf.
  • Have current technical documentation (STED/Technical File/Design Dossier) and an Australian Declaration of Conformity ready for submission to the TGA.
  • Unless your device is in the lowest risk class, your Sponsor submits your Manufacturer’s Evidence for the TGA’s review and acceptance.
  • For all devices, your Sponsor submits a medical device application. Pay the application fee. The TGA may review sections of your technical documentation as part of an application audit.
  • Upon TGA approval, you will be issued an ARTG listing number and your Sponsor can print the ARTG Certificate of Inclusion from the TGA Business Service website.

Things to consider before placing a device on the Australian market

  • Once a medical device has been included in the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval. The TGA has mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices
  • There is a mandatory audit for certain device classifications (Class III and above)

Official links
Therapeutic Goods Administration (TGA) https://www.tga.gov.au/

Please note; these offer a general overview of access routes, full pathways and requirements will vary greatly dependent on device type and risk class amongst other variables. If you’re interested in placing a device on the Australian market, do not hesitate to contact us at hello@imedconsultancy.com.

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