Europe
The new article highlights aspects related to changes to medical device registration and also describes in detail the public register of medical device manufacturers. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating...
FDA
The new article highlights aspects related to pyrogenicity, (accelerated) aging, packaging, ensuring that the sterility of the device is duly maintained, as well as biocompatibility for all the components and patient-contacting materials. Table of Contents The Food...
Brazil
The new article addresses aspects related to the way the authority’s consent should be obtained prior to importing medical devices to Brazil. Table of Contents The Brazilian regaling authority in the sphere of healthcare products (ANVISA), has published a guidance...
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...
