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...
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...
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...
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...
In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device regulations. The two most significant changes discussed were new requirements related to foreign risk...
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