Australian TGA Sponsor Representation for Device Companies
ANSWERED ON THIS PAGE:
- Do we need in-country representation in Australia?
- What is the role of an Australia TGA Sponsor?
- Can we select a distributor as our Sponsor in Australia?
Medical device and IVD manufacturers that are not based in Australia must select an in-country representative, called an Australian Sponsor, or TGA Sponsor. Your TGA Sponsor plays an important role in the device registration process and post-market compliance, so it is important to select a highly qualified, independent representative. With a physical office in Sydney, Australia, Emergo acts as a professional Sponsor for medical device and IVD companies located throughout the world.
Responsibilities of an Australian TGA Sponsor for medical device companies
The Sponsor acts as a liaison between you and the Therapeutic Goods Administration (TGA), as specified by the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. The Sponsor assumes regulatory representation for the product in the Australian market and is responsible for registering your device with the TGA. To maintain control over your device and IVD registration, we recommend that you appoint a "third party" Sponsor who is not commercially involved in the sale of your products and acts solely as your regulatory representative in Australia.
What Emergo provides as your TGA Sponsor for Australia:
Emergo has been a Sponsor service provider for medical device companies since 2004. We maintain offices in over 25 countries worldwide, and can act as your in-country representative through our local offices in these markets as well.
- Register your medical device(s) and IVD(s) with the TGA prior to commercialization.
- Act as your primary point of contact for the TGA.
- Ensure that your Technical File is made available for inspection by the TGA.
- Authorization to place our name and address on your device labels, packaging, Instructions for Use, etc.
- In-house regulatory experts to interact between you and the TGA.
- Assistance with vigilance: Reportable Recalls/Adverse Events reporting to the TGA, in cooperation with you and your distributors.
- Protection of your confidential documentation - the Sponsor can only show them to the TGA.
- Represent you to the TGA for consultation in case of withdrawal of a medical device from the market.
- Secure online access to Labeling Information & Symbols, Technical Dossier Templates, Quality System Procedures (QSPs or SOPs), Medical Device Regulations, Vigilance Guidelines, Classification Guidelines, Reportable Recalls/Adverse Events, Harmonized Standards, and more.
Emergo is a professional, independent TGA Sponsor that focuses 100% on medical device and IVD regulatory affairs and quality management. Your success in Australia is our goal. Ask us about our special 3-year package for new Australia Sponsor representation clients.
Can we select an Australian distributor as our Sponsor?
While you are allowed to appoint a distributor to be your Australian Sponsor, this option comes with some risks you should be aware of. For example, TGA Registration of your devices is completed by your selected Sponsor. If you appoint a distributor and then cease doing business with that distributor, you must start the registration process over again with a new Sponsor, change your device labeling, possibly delaying market access, and pay new registration fees.
The distributor is focused on sales. Do you feel that your distributor stays up to date on regulatory changes in Australia and will provide you with timely warnings when changes affect your devices? Most distributors are not aware of the role of the Sponsor and the mandatory regulatory responsibilities that come with it, including incident reporting and post-market surveillance.