Get Expert Regulatory Services from Australian Healthcare Solutions

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Get Expert Regulatory Services from Australian
Healthcare Solutions
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• TGA approval and subsequent listing on the
  Australian Registered Therapeutic Goods Register
  (ARTG) is required to sell a medical technology
  within Australia.

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• The Therapeutic Goods Association (TGA) is
  Australias governing authority for medical
  technology. Our dedicated regulatory consultants
  are TGA experts.

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• With their knowledge of the Australian regulatory
  system they will help plan and streamline your
  pathway to market launch, minimising delays and
  unforseen costs.

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• We offer expert regulatory services
• Regulatory analysis and strategy development for
  local or international companies, for listing
  with the TGA

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• Compilation of required technical documentation
• Preparation of applications for ARTG inclusion

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• Development of quality management systems to
  comply with ISO 13485
• Development of post-market surveillance systems

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• Review of promotional materials for compliance
  with the Australian Therapeutic Goods Advertising
  Code (TGAC).
• http//australianhealthcaresolutions.com.au/