FDA
The new article highlights aspects related to the MDDT program, its intended purpose, and its benefits. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance...
Australia and Oceania
The new article addresses aspects related to the documentation to be provided by the interested party responsible for the medical device in question and also describes the way the fees associated with the application audit should be calculated. Table of Contents The...
FDA
The new article highlights aspects related to sterility and reprocessing for both sterile and non-sterile. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft...
Brazil
The new article addresses aspects related to the importation of used products, radioactive elements, and products containing animal tissue. Table of Contents The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published revised...
FDA
The new article provides an overview of a guidance document issued by the US regulatory authority and highlights the key points to be taken into consideration by interested parties with respect to the existing legal framework. Table of Contents The Food and Drug...
