Canada – Health Canada Proposes Changes to Priority Review Requests for Medical Devices

Health Canada intends to modify its policy for medical device manufacturers to request priority reviews by nixing its requirement on a separate submission and adding a new required criterion for eligibility.

The existing process for medical device manufacturers to request priority reviews for expedited entries to the Canada market is “still relevant” but “unnecessarily complex,” Health Canada argued in a recent notice of intent.

The conclusion was reached based on a review of the preferential prioritization system under an interim policy implemented in 2000. Consideration should also be given to unforeseen or unmet urgent health needs in granting priority reviews on license applications in addition to the criteria under the interim policy, the regulatory authority said, pointing to the newly proposed criterion for Class III and IV devices…