Australian TGA Sponsor
Medical device and IVD manufacturers situated 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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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.
Ready to Take the Next Step?
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!
MDSS History
MDSS AU Pty Ltd is part of a global network of medical device and IVD in-country representatives. 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.
Contact MDSS AU Pty Ltd
- Address Suite 55, 377 Kent Street, Seabridge House, Sydney NSW 2000, Australia
- Email info@mdssau.com