Australia and Oceania
The new article provides an overview of the recent changes to the classification rules for certain medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a...
FDA
The new article covers the aspects related to usability testing to be conducted, and also to electrical safety and electromagnetic compatibility. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Asia
The article covers the general points related to the regulatory requirements for combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published the guidelines for...
FDA
The new article highlights the aspects related to the way the impact of viral mutations can be addressed when developing tests. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
FDA
The new article describes the recommended content and highlights the key points to be considered in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
FDA
The new article addresses the aspects related to the scope of events eligible for the program, as well as to its general conditions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
