Brazil
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
FDA
The new article describes the types of medical devices covered by the scope of the guidance and highlights the key points to be taken into account in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Europe
The article provides an overview of the regulatory policy to be applied to software products and highlights the key points associated thereto. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority, has published...
FDA
The new article describes in detail the main concepts used in the context of medical device recalls and enhancements in terms of determination of their legal nature and actions to be taken by the parties involved. Table of Contents The Food and Drug Administration...
Australia and Oceania
The new article highlights additional aspects related to clinical evidence for joint prostheses in terms of post-market surveillance, which become especially important since such devices are intended to be used for a long period, so their long-term safety and...
FDA
The new article provides additional details regarding some of the matters related to evidence, including the benefit-risk assessment. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
