Australia and Oceania 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...
Australia and Oceania 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...
Australia and Oceania 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...
Australia and Oceania The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document describes in detail the procedures to be followed...
Australia and Oceania The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published a document providing examples of regulated and unregulated software and software-based medical devices. The document is intended to assist...
