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...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical device regulations, has published detailed guidelines describing how one can determine whether software falls within the scope of medical device regulatory...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has announced a public consultation on proposed amendments to the regulatory framework for medical devices that are substances introduced into 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...
