Australian TGA Sponsor

Medical device and IVD manufacturers based outside Australia are required to appoint an In-Country Representative, known as an Australian Sponsor or Australian TGA Sponsor, who will include your devices in the Australian Register of Therapeutic Goods (ARTG). This TGA Sponsor assumes a critical role in both the device registration process and post-market compliance activities. Hence, it is vital to choose a highly competent and independent representative. MDSS AU Pty Ltd, with its physical presence in Sydney, Australia, offers comprehensive Australian TGA Sponsor services to aid manufacturers of Medical Devices and IVDs in navigating the ARTG registration process for their devices.

Australian TGA Sponsor Responsibilities and TGA Registration

As specified by the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002, the Sponsor serves as the liaison between the manufacturer and the Therapeutic Goods Administration (TGA). The Sponsor takes on regulatory representation for your devices within the Australian market and undertakes the responsibility of registering the devices with the TGA.

While the Therapeutic Goods Administration (TGA) acknowledges approvals from other markets such as CE Marking and FDA clearance, devices still need to undergo registration with the TGA. This involves a thorough application review and, depending on the device classification, a documentation review. While manufacturers may leverage approvals from various regulatory agencies, most opt to apply their CE Marking when registering devices in Australia.

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Facts about the Australian healthcare landscape

– Australia spends an average $8,617 per person per year on healthcare, this puts Australia 11^th of 38 OECD countries in terms of money spent on healthcare – this spend represented 10.7% of total gross domestic product (2020/2021)

– Australia ranks number 10 in the OECD in terms of life expectancy (2019) and has an ageing population

– The medical equipment sales market in Australia is expected to grow at a CAGR of 6.09% from 2023 to 2028

– The US International Trade Administration (ITA) describes the Australian healthcare market as ‘sophisticated, mature, and quick to adopt new healthcare technologies’ it also states that ‘Approximately 85% of domestic demand for medical devices and diagnostics is met by imports’

– The Value of MedTech Report, commissioned by the Medical Technology Association of Australia (MTAA), highlights the significant contributions and future potential of the MedTech industry to Australia’s healthcare system and economy, based on recent survey data and secondary sources.

Regulatory barrier to entry

– The Australian medical device regulatory framework is based on IMDRF guidelines and is strongly aligned with the European CE mark system

– The TGA takes into consideration existing approvals from certain overseas regulators, meaning you may be eligible for a less burdensome path to approval in Australia

– Manufacturers who hold regulatory approval from certain ‘comparable overseas regulators’ have a lower barrier to enter when it comes to registering their devices with the TGA

o Such comparable overseas regulators include EU notified bodies, US FDA, Health Canada, The Japanese Ministry of Health, Labour and Welfare and the Health Sciences Authority of Singapore and MDSAP certification
- ♣ Do you hold any of the above-mentioned regulatory approvals?
- ♣ If so, the regulatory approval process for the Australian market could be much less burdensome than you expect

What We Offer as Your Australian TGA Sponsor:

Registration of your product on the ARTG.
Authorize the placing of MDSS AU Pty Ltd details on your labeling.
Serve as your main liaison with the TGA.
Ensure the availability of your Technical File for TGA inspection.
Review of Technical Documentation and Clinical Evaluation Report for TGA registration compliance.
Guidance on TGA, registration, and labelling requirements.
Dedicated TGA contact and support with vigilance activities, including reporting Recalls/Adverse Events to the TGA in collaboration with you and your distributors.
Access to our expert regulatory team for TGA communication.

Advantages of Appointing MDSS as Your Dedicated Australian TGA Sponsor:

Providing the Sponsor complete access to Technical Documentation is crucial and companies often hesitate to disclose confidential design specifics to distributors or importers. By designating a single dedicated TGA Sponsor, the need to share sensitive information with multiple parties is eliminated.
Your documentation, including labeling and manuals, must prominently display the Sponsor’s name and address. In the event of distributor changes, reprinting labels and manuals becomes necessary, potentially leading to conflicts during recalls or incident reporting. By choosing a dedicated TGA Sponsor manufacturers have one less consideration when changing distributors.
The primary focus of distributors does not lie in regulatory affairs. While distributors may excel in areas of sales, marketing, and distribution, regulatory tasks are not interchangeable with these objectives. With an independent Sponsor you will stay alert to regulatory changes impacting your devices.

Whether you are a small start-up or a multinational corporation, MDSS AU Pty Ltd is dedicated to assisting you in achieving your market objectives in Australia!

Select MDSS as Your Australian TGA Sponsor!

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MDSS History

MDSS AU Pty Ltd is part of a global network with over 30 years history on medical device and IVD in-country representation. With our headquarters located in Hannover, Germany, we support medical device manufacturers in gaining market access in the EU, UK, Switzerland, USA and now Australia.