Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to recalls. The document provides general information about recalls and also a detailed description of the main phases of the recall...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device recalls. The document provides guidelines to be followed by medical device manufacturers with regard to their products...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidelines dedicated to recalls. The document covers the most important aspects related to the recall of medical devices placed on the...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for marketing approval and post-market monitoring and surveillance in the sphere of medical devices, has published an official notice dedicated to special action taken to...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The document is intended to provide additional clarifications regarding the applicable regulatory requirements...
