Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices has published detailed guidelines dedicated to sponsorship with regard to placing medical devices on the Australian market. Regulatory Background According...
Australia and Oceania
The Therapeutic Goods Administration (TGA) provided a set of detailed guidance documents to assist medical device manufacturers in achieving and sustaining compliance with regulatory requirements to be allowed for marketing in Australia – the Australian...
South America
Argentina informs about more upcoming changes in their medical device registration procedures. The appropriate amendments would be implemented in two consecutive steps: on March 6, 2020, and on March 16, 2020, respectively. In particular, the amendments are set forth...
Australia and Oceania
The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities...
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