Ethiopia The article provides a brief overview of the Ethiopian guidelines for medical device manufacturers’ Good Manufacturing Practices site inspection management. Table of Contents The Ethiopian Food and Drug Administration (EFDA), a country’s...
Canada Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to inspections of medical device establishments. The document outlines the main principles of inspections to be carried...
Canada Health Canada, a Canadian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to inspections of medical device establishments. The current version of the document was published in November 2016 and replaced the...
Kazakhstan The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules for inspections with regard to medical devices. New...
FDA The Food and Drug Administration (FDA or the Agency) issued updated guidance on processes and standards for the inspections of medical device establishments. Inspections Regulatory Backgrounds The new approach to medical device establishment inspections is based on...
