The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
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...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software-based medical devices. In particular, the document provides examples of software products that...