Regulatory

TGA approval and subsequent listing on the Australian Registered Therapeutic Goods Register (ARTG) is required to sell a medical technology within Australia.

The Therapeutic Goods Association (TGA) is Australia’s governing authority for medical technology.  Our dedicated regulatory consultants are TGA experts.  With their knowledge of the Australian regulatory system they will help plan and streamline your pathway to market launch, minimising delays and unforseen costs.

Australian Healthcare Solutions offers expert regulatory services:

  • Regulatory analysis and strategy development for local or international companies, for listing with the TGA
  • Compilation of required technical documentation
  • Preparation of applications for ARTG inclusion
  • Development of quality management systems to comply with ISO 13485
  • Development of post-market surveillance systems
  • Review of promotional materials for compliance with the Australian Therapeutic Goods Advertising Code (TGAC).