FDA
The Food and Drug Administration (FDA or the Agency), the country’s regulating authority in the sphere of healthcare products, has developed detailed guidelines dedicated to labeling requirements for various types of medical devices. The present article supplements...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the interpretation of significant changes to a medical device. In particular, the guidance describes...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the types of medical device license applications. In particular, the document describes how medical devices could be combined when...
FDA
The core principles of the regulatory approach for labeling for medical devices are described in a guidance document issued by the Food and Drug Administration (FDA or the Agency), the US regulating authority, earlier in 1989. Since that time, the document has been...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the investigation of reported problems associated with medical devices. The latest version of the document...
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