How are medical devices approved for use and monitored for safety?
The approval process varies by medical device class. Licensing applications for higher risk devices (Class III and IV) must provide evidence of their clinical effectiveness, including clinical trials and reviews, meta-analyses and real-world evidence reviews. To be licensed, a medical device’s risks must be mitigated as much as possible and the regulatory agency must determine the benefits of its use outweigh any remaining risks. Post-licensing monitoring includes: inspections, reports noting information that may change the devices expected risks and benefits, and compiling information on recalls, complaints and problem reports from a variety of consumer and medical sector sources. Both manufacturers and Health Canada have responsibilities to monitor medical devices that have been approved for sale and distribution.