Australia and Oceania
Australia’s Therapeutic Goods Administration (TGA) has published updated guidance dedicated to personalized medical devices. Apart from other aspects, the document addresses the regulatory matters related to the medical device production systems (MDPS). Table of...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published an updated guidance document dedicated to personalized medical devices (including 3D-printed devices). The document constitutes a...
Australia and Oceania
The Therapeutic Goods Administration (TGA), Australia’s regulating authority in the sphere of healthcare products, has published a final document describing the refinements to the personalized medical devices framework. The new regulatory approach announced by...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidance on regulatory changes for software-based medical devices. The present document constitutes an updated version of guidance...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document that addresses the information accompanying (active) implantable medical devices, including patient information...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device patient information leaflets. The document outlines the scope of information the...
