The new article describes in detail the approach to be applied for clinical evidence for joint prostheses. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance...
The present guidance provides additional details regarding the regulatory requirements for active and passive implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of medical devices,...
The new article describes the aspects related to safety considerations for medical devices used in MR environments. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a...
The new article provides additional clarifications regarding the way two medical devices could be compared for the clinical evidence to be used in a new marketing application. Table of Contents The Therapeutic Goods Authority (TGA), an Australian regulatory agency in...
The new article describes in detail the approach to be applied concerning comparable devices including substantially equivalent devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...