Aug 6, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document is intended to assist medical device manufacturers and other parties involved in...
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Aug 4, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices already placed on the market. The document is intended to assist medical...
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Jul 30, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device license application types. Apart from the general description of existing medical device application types, the...
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Jul 28, 2021
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...
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Jul 23, 2021
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...
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Jul 22, 2021
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...
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