Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document describing changes to the regulatory framework for software-based medical devices. The document describes the...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a user guide on the post-market review compliance dashboard. The document describes in detail how responsible parties can access, review and...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published an official information notice dedicated to custom-made medical devices. The notice is intended to provide...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper describing proposed changes to the regulation of personalized medical devices. As mentioned in our previous article...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper dedicated to the proposed refinements to the regulation of personalized medical devices. Table of Contents...
