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Postmarket surveillance changes, digital health division eyed by Canada

Two notices of intent have been issued by Health Canada to modify postmarket surveillance regulations for Class II, III and IV medical devices and to create a division in the Therapeutic Products Directorate's Medical Devices Bureau to streamline premarket review of digital health products. The division will concentrate on software as a medical device, wireless medical devices, mobile medical apps, artificial intelligence, cybersecurity, telemedicine and medical device interoperability.

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