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.
Postmarket surveillance changes, digital health division eyed by Canada
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