Australian Sponsor (TGA) Services for Medical Devices and IVDs

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

Appointment of an Australian Sponsor is a regulatory requirement for most overseas manufacturers supplying devices in Australia. PracticalRA acts as a professional, compliance-focused Sponsor, supporting manufacturers with market access, regulatory obligations, and ongoing compliance under Australian regulatory requirements.

Our Australian Sponsor service is designed for manufacturers who require a reliable local regulatory partner, not a passive administrative intermediary.

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Why an Australian Sponsor Is Critical for Market Access

For most overseas manufacturers, products cannot be legally supplied in Australia unless an Australian Sponsor is appointed.

The Australian Sponsor:

  • acts as the local regulatory point of contact
  • supports inclusion of devices in the ARTG
  • holds specific regulatory responsibilities under Australian legislation
  • supports post-market compliance activities

Choosing the right Sponsor is therefore critical. Not only for initial market entry, but for ongoing regulatory compliance and business continuity.

Practical RA provides Australian Sponsor services aligned with regulatory expectations, risk management principles, and practical execution.

Service Overview

Australian Sponsor Appointment

Appointment as Australian Sponsor for overseas manufacturers supplying medical devices or IVDs in Australia.

ARTG & Regulatory Support

Support with ARTG-related regulatory activities and Sponsor obligations.

Ongoing Compliance Support

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

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:

  • Australian Sponsor appointment and onboarding
  • 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 generally 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

Frequently Asked Questions

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

An Australian Sponsor is required when an overseas manufacturer supplies medical devices or IVDs to Australia and does not have an Australian legal entity responsible for regulatory obligations.

In some cases, yes. However, many manufacturers prefer an independent Sponsor arrangement to ensure clarity of responsibilities and continuity if distribution arrangements change.

Yes. Practical RA provides Australian Sponsor services for both medical devices and in vitro diagnostic medical devices.

Timelines depend on device type, readiness, and required scope. This is assessed during the initial onboarding discussion. The majority of our clients have their applications submitted to the TGA within 2 weeks.

Yes. We provide ongoing Australian Sponsor support in line with the agreed scope, including assistance with TGA audit requests and post-market reporting obligations across the product lifecycle.

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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