The new article describes in detail the regulatory approach to be applied concerning patient-matched medical devices in general and to the design envelope in particular. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulatory agency in...
The article provides an overview of the recent changes to the Australian guidelines on clinical evidence. In particular, the document highlights the key points related to the inclusion of recommendations related to software products and personalized devices. Table of...
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published a questions-and-answers document addressing the most important aspects related to software-based medical devices. The document is intended to...
The second article provides an in-depth review of the TGA application form and describes the way the submitter should provide information about the applicant entity and the medical device(s) subject to review. The Therapeutic Goods Administration (TGA), an Australian...
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to applying for consent to import, supply, or export a medical device that does not comply with the...