Australian TGA Sponsor Service for Medical Devices and IVDs — Melbourne-Based TGA Expertise

Practical RA provides Australian Sponsor services for overseas manufacturers of medical devices and in vitro diagnostic devices (IVDs) seeking access to the Australian market via the Therapeutic Goods Administration (TGA).

Under Australian law, overseas manufacturers cannot legally supply medical devices in Australia without appointing an Australian Sponsor. The Sponsor holds formal regulatory responsibilities under the Therapeutic Goods Act 1989, acts as the TGA’s local point of contact, and is responsible for supporting ARTG inclusion and ongoing post-market compliance. Choosing the right Sponsor, one who understands your device, your existing global approvals and the TGA’s expectations, is one of the most consequential decisions you will make when entering the Australian market.

Practical RA is a boutique regulatory firm headquartered in Melbourne, Australia. Unlike many offshore TGA Sponsor providers, our team works locally, engages directly with the TGA, and brings hands-on experience across medical devices and IVDs of all classifications. Our Australian Sponsor service is led by Tara Silva, who joined our team from a large multinational regulatory firm and has developed genuine working relationships within the Australian medical device regulatory community.

If you hold CE Marking under EU MDR 2017/745 or US FDA clearance, you may be eligible for an abridged TGA pathway, significantly reducing the time and cost to Australian market access. Most of our clients have their applications submitted to the TGA within 2 weeks of completing onboarding.

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Using Your Existing CE Marking or FDA Clearance for TGA Registration

One of the most underutilised advantages for overseas manufacturers entering the Australian market is the TGA’s recognition of comparable overseas regulatory approvals. If your device already holds CE Marking under EU MDR 2017/745 or US FDA clearance, this can be used to support an abridged TGA application, often dramatically reducing the documentation burden and approval timeline compared to a full TGA conformity assessment.

CE Marking (EU MDR 2017/745)

The TGA recognises Conformity Assessment documents issued by EU Notified Bodies as manufacturer evidence to support ARTG inclusion applications. For most device classes, this means your existing EU MDR technical documentation and Notified Body certificate can underpin your TGA application, without requiring a separate full conformity assessment by the TGA. Practical RA’s dual expertise in EU MDR and TGA requirements means we understand exactly how your existing European documentation maps to Australian requirements and where the gaps are.

US FDA Clearance (510(k) / PMA)

US FDA 510(k) clearance and PMA approval are recognised by the TGA and can support ARTG inclusion under specific pathways. For Class IIa devices exempt from FDA 510(k) requirements, and for Class III devices holding 510(k) clearance, dedicated TGA pathways exist that leverage your existing US approval. Our team’s experience across both FDA and TGA regulatory frameworks makes us uniquely placed to advise on the fastest and most cost-effective route to market.

What This Means in Practice

  • Manufacturers with existing EU MDR CE Marking or FDA clearance typically face a significantly lower documentation and cost burden for TGA registration
  • The TGA accepts IMDRF STED format technical documentation, which aligns with both EU and US submission formats
  • For Class I and Class IIa devices with comparable overseas approvals, ARTG inclusion timelines of 4 to 6 weeks are achievable
  • Class IIb and Class III devices may be subject to TGA audit, but existing international approvals strengthen the application considerably
  • Practical RA coordinates the full process, assessing your existing approvals, identifying any Australia-specific gaps, and managing the ARTG application on your behalf

Service Overview

Documentation Review

As your Australian Sponsor we ensure all your technical documentaion is aligned with TGA requirements, to avoid costly future penalties

ARTG & Regulatory Support

Support with ARTG-related regulatory activities and Sponsor obligations, including TGA Audits and Market Actions.

Ongoing Compliance Support

Ongoing Australian Sponsor support to assist with regulatory responsibilities across the product lifecycle.

How the Australian TGA Sponsor Appointment Process Works

For overseas manufacturers approaching the Australian market for the first time, the process of appointing an Australian Sponsor and achieving ARTG inclusion typically follows these stages:

Step 1 — Initial Assessment

We review your device type, classification, and existing global regulatory approvals (CE Marking, FDA clearance, MDSAP, etc.) to determine the most appropriate TGA pathway. We confirm your Australian device classification, which may differ from your EU or US classification due to Australia-specific classification rules, and provide a clear roadmap for ARTG inclusion.

Step 2 — Sponsor Agreement and Appointment

We formalise the Sponsor relationship through a written agreement that clearly defines responsibilities for both parties. Practical RA is formally appointed as your Australian Sponsor under the Therapeutic Goods Act 1989, and your manufacturer details are confirmed for inclusion in the ARTG application.

Step 3 — Documentation Review and Preparation

We review your existing technical documentation against TGA requirements, identify any Australia-specific gaps, and coordinate any additional documentation required. For manufacturers with EU MDR or FDA approvals, this step is typically straightforward; the TGA accepts documentation in formats already familiar from international submissions.

Step 4 — ARTG Application Submission

We prepare and submit the ARTG inclusion application to the TGA on your behalf, including all required manufacturer evidence and supporting documentation. For most devices up to Class IIb with comparable overseas approvals, we target application submission within 2 weeks of completing the documentation review.

Step 5 — TGA Review and Approval

The TGA reviews the application and may request additional information or select the application for audit. For Class IIb and Class III devices, a mandatory Level 2 audit involves TGA review of technical documentation. We manage all TGA communications and coordinate any additional information requests throughout this process.

Step 6 — Ongoing Sponsor Obligations

Once your device is included on the ARTG, your obligations as a manufacturer and ours as your Sponsor continue throughout the product lifecycle. This includes post-market surveillance reporting, adverse event reporting, maintaining current manufacturer evidence (including keeping your CE Certificate or FDA clearance current), and responding to any TGA audit or market action requests. Practical RA provides ongoing Sponsor support as agreed in your service scope.

Tara Silva

Australian Sponsor
Program Manager

You’re in good hands

We are a boutique firm with offices in Melbourne, Australia. We have local team members who engage regularly with the TGA, unlike many larger corporations that are based entirely off-shore.

Our Australian Sponsor service is lead by Tara Silva, who joined our team from a large multi-national regulatory firm.

“The medical device community in Australia is small and tight-knit. This includes the regulators at the TGA, with whom we have been able to cultivate strong professional connections with over several years.”

Schedule a call or contact Tara directly at tara@practicalra.com

Why Overseas Manufacturers Choose Practical RA as their Australian Sponsor

Melbourne-Based with Direct TGA Engagement

Unlike many Australian Sponsor providers who operate from offshore or maintain only a nominal Australian presence, Practical RA is headquartered in Melbourne with a team that actively engages with the TGA. This means faster response times, better visibility of TGA expectations and emerging requirements, and a Sponsor who is genuinely reachable when you need them.

Expertise Across EU MDR, US FDA, TGA and New Zealand Medsafe

Most overseas manufacturers seeking an Australian Sponsor already hold EU MDR CE Marking or US FDA clearance. Practical RA is one of the few Sponsor providers with deep, active expertise across all three regulatory frameworks. This means we can accurately assess how your existing documentation maps to TGA requirements, identify gaps efficiently, and maximise the value of your international approvals in the Australian registration process, rather than treating your TGA application in isolation. Additionally, we offer New Zealand Sponsor services allowing you to bundle your Australasian market access with a single point of contact.

A Boutique Practice, Not a Passive Administrator

We are a boutique regulatory firm. This means your account is handled by specialists, not processed through a large offshore administrative system. Our Australian Sponsor service is led by Tara Silva, who brings direct experience from a large multinational regulatory firm combined with the responsiveness and personal accountability that a smaller practice provides. We do not act as passive intermediaries. We take our Sponsor responsibilities seriously and work proactively on your behalf.

Transparent Scoping and No Hidden Fees

Our service scope and fees are discussed clearly during initial consultation, based on your device type, classification, and what is actually required. We do not apply one-size-fits-all pricing, and there are no unexpected charges. If your situation changes (new devices, classification changes, distributor restructuring) we discuss the implications with you openly.

Medical Devices and IVDs We Support

Practical RA provides Australian Sponsor services for medical devices, IVDs, systems and procedure packs. If you are unsure whether your product is regulated as a medical device or IVD in Australia, this can be assessed during initial discussions.

What Our Australian Sponsor Service Covers

Australian Sponsor services are scoped based on device type, classification, and supply model, and includes:

  • Confirmation of Australian device classification
  • Support for ARTG inclusion activities (as applicable)
  • Regulatory coordination with the TGA
  • Alignment of Sponsor responsibilities with manufacturer documentation
  • Support for post-market compliance activities, as agreed
  • Ongoing availability for Sponsor-related regulatory matters

Who Requires an Australian Sponsor?

You will require an Australian Sponsor if you are:

  • an overseas manufacturer without an Australian legal entity
  • supplying medical devices or IVDs to Australia via a distributor
  • entering the Australian market for the first time
  • changing Sponsor arrangements
  • expanding or maintaining an Australian product portfolio as part of your global strategy

Frequently Asked Questions

Questions we commonly receive from device manufacturers looking for their Australian Sponsor:

An Australian Sponsor is required whenever an overseas manufacturer — one without an Australian legal entity — supplies medical devices or IVDs to the Australian market. This applies regardless of whether supply is direct or through a distributor. Without an appointed Sponsor, it is not legally possible for an overseas manufacturer’s device to be included on the ARTG, and supply without ARTG inclusion is an offence under the Therapeutic Goods Act 1989 (with some limited exemptions).

Yes, in many cases a distributor can act as the Australian Sponsor. However, there are important practical reasons to consider an independent professional Sponsor instead. If your distribution arrangements change — or if you appoint multiple distributors — a Sponsor tied to a single distributor creates regulatory complexity. An independent Sponsor like Practical RA provides continuity regardless of your commercial arrangements, and a clearer separation of regulatory and commercial responsibilities. This is increasingly the preferred model for manufacturers building a long-term Australian market presence.

Not necessarily. The TGA recognises a range of comparable overseas approvals that can be used to support ARTG inclusion without requiring a separate full TGA conformity assessment. These include CE Marking under EU MDR 2017/745, US FDA 510(k) clearance and PMA approval, and MDSAP certification with Australia in scope. The applicable pathway depends on your device class and the nature of your existing approvals. Practical RA will assess your situation and identify the fastest and most cost-effective route to ARTG inclusion.

Timelines depend on device classification, the nature of your existing approvals, and whether the TGA selects your application for audit. As a general guide: Class I and Class IIa devices with comparable overseas approvals can typically achieve ARTG inclusion within 4 to 6 weeks. Class IIb devices typically take 6 to 8 weeks. Class III and Active Implantable Medical Devices (AIMDs) are subject to mandatory Level 2 audit and may take up to 6 months. For most devices, Practical RA targets TGA application submission within 2 weeks of completing the documentation review.

Costs fall into two categories: TGA government fees and professional service fees. TGA government application fees are set by the Australian government and vary by device class — currently ranging from approximately AUD 621 for Class I devices to AUD 1,530 for Class III devices per product, plus annual ARTG maintenance fees. Professional fees for our Australian Sponsor service are scoped based on device type, classification, and service requirements, and are discussed transparently during initial consultation. There are no hidden fees.

Changing your Australian Sponsor is possible and involves a formal transfer process with the TGA. The existing Sponsor must complete and submit a transfer form to the TGA, after which the new Sponsor assumes regulatory responsibilities. The new Sponsor is required to submit manufacturer’s evidence as part of the transfer. It is important that ARTG listings remain active throughout the transfer process. Practical RA can manage incoming transfers and advise on the process if you are looking to change from your current Sponsor arrangement.

Yes — and this is an important consideration that is often overlooked. While Australia’s risk-based classification system is broadly comparable to EU and US frameworks, there are differences in interpretation and specific classification rules under the Therapeutic Goods (Medical Devices) Regulations 2002. It is not safe to assume your EU MDR or FDA classification will automatically apply in Australia. Practical RA conducts an Australian classification assessment as part of the initial onboarding process to ensure the correct classification is established before the ARTG application is submitted.

Yes. Ongoing Australian Sponsor support is included as part of our service scope and covers post-market compliance activities across the product lifecycle — including TGA audit requests, adverse event and incident reporting obligations, maintaining currency of manufacturer evidence, and any required market actions or recalls. The Sponsor’s regulatory responsibilities under Australian law do not end at ARTG inclusion, and we take those responsibilities seriously throughout our engagement.

For most medical device manufacturers with existing CE Marking or FDA clearance, the answer is yes. Australia’s abridged TGA pathway for devices with comparable overseas approvals means the incremental cost and effort to access the Australian market is substantially lower than it was under previous regulatory arrangements. Australia imports approximately 80% of its medical device market needs, creating consistent demand for innovative products. The TGA is also widely regarded as a rigorous, internationally respected regulator — meaning ARTG inclusion carries real market credibility. For manufacturers already navigating EU MDR or FDA, the additional compliance burden is manageable with the right Sponsor partner.

You’re in good hands with the expertise of Practical RA

If you are an overseas manufacturer seeking an Australian Sponsor for medical devices or IVDs, please contact Practical RA to discuss your requirements.

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