Since 2004, Emergo has been a provider of sponsorship services for medical device companies. We have branches in more than 25 countries around the world and we can also be your local representative through our local subsidiaries in these markets. Can I choose an Australian distributor as a sponsor? While you can appoint a distributor as an Australian sponsor, this option comes with a few risks to consider. For example, the TGA registration of your devices is completed by your selected sponsor. If you appoint a distributor and then stop doing business with that distributor, you need to restart the registration process with a new sponsor, change your device label, perhaps delay market access, and pay a new registration fee. Medical device and IVD manufacturers who are not established in Australia must select a representative in the country designated as an Australian sponsor or a TGA sponsor. Your TGA sponsor plays an important role in the device registration process and in post-market compliance, so it`s important to choose a highly qualified independent representative. With a physical office in Sydney, Australia, Emergo is a professional sponsor for medical device and IVD companies worldwide. Emergo is a professional and independent sponsor of TGA that focuses 100% on regulatory issues and quality management of medical devices and IVD. Your success in Australia is our goal. Ask us for our special 3-year package for new Australian sponsor customers.
Sponsor serves as a link between you and the Therapeutic Goods Administration (TGA), as set forth in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. The sponsor provides regulatory representation of the product in the Australian market and is responsible for registering your device with the TGA. In order to maintain control over your device and IVD registrations, we recommend that you appoint a “third” sponsor who will not be commercially involved in the sale of your products and will act exclusively as your legal representative in Australia. The distributor focuses on distribution. Do you feel that your distributor stays informed of regulatory changes in Australia and notifies you in time if the changes affect your devices? Most distributors are not aware of the role of the sponsor and the mandatory regulatory responsibilities associated with it, including incident notification and post-market monitoring….