Australian medical device company

If your company does not have a physical location within the country, Australian law dictates that you must appoint a "sponsor" who is located in Australia to act as its liaison with the Therapeutic Goods Administration (TGA). Emergo is an official sponsor for Australia with physical offices located in Sydney, Australia.

Why choose us as your sponsor Australian?

Emergo Australia Pty. Ltd. is an expert provider of TGA for medical device companies. We are a veterinary consulting firm established ISO certified since 1997 by 100% devoted to the issues of quality assurance and registration of medical devices and products In-Vitro Diagnostic (IVD). Emergo also specializes in veterinary matters European, American, Chinese, Mexican, Brazilian and Japanese so we can act as your representative in the country through our offices located in these markets.

Contact us for more information or a proposal on representation as a sponsor to the TGA.

What we offer as a Sponsor of the TGA for Australia:

  • Register your (s) device (s) doctor (s) to the TGA before being marketed (s).
  • Act as the primary point of contact for the TGA.
  • Keep available a current copy of your technical documents for inspection by the TGA.
  • Authorization to place your name and address on the labels of their devices, packaging, instructions for use, etc..
  • Permanent availability to interact between you and the TGA.
  • Responsibility for incident reporting to the TGA, in cooperation with you and your distributors.
  • Protect the confidentiality of your documents. Sponsor can only show it to the TGA.
  • Availability to represent to the TGA for consultation in case of recall of a medical device.
  • Maintain reports on the critical evaluation of all data collected during clinical evaluations for review by the TGA.
  • Secure online access to information and labeling symbols, templates Technical files, Proceedings of the quality systems (QSPs or SOPs), Medical Device Regulations, Guidelines for surveillance, classification guidelines, Pickup / reportable incidents, harmonized standards and more.
  • Notify or be notified by the TGA on serious incidents devices.

Contact us for more information or a proposal on representation as a sponsor to the TGA.

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2005-10-21 23:58:11 by --------------

Misleading for Americans

Lost within the assertion that Americans gobble more than their fare share of resources is a very important fact: Americans are among the most creative and productive people in the world.
Technologies pioneered in the US and demanded by nearly everyone in the world:
- Electricity
- Telecommunications
- Transportation
- Aviation
- Television
- Plastics
- Pharmaceuticals
- Medical Devices
- Computers
- Internet
- And on and on.
Although we can and must be thoughtful about our use of our natural world, it is important to acknowledge that Americans and the West have advanced science and technology in the past 100 years far further than the rest of the world

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