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26. 11.2018

Health Canada Proposes Changes to Priority Review Requests for Medical Device

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.

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.

Further, Health Canada intends to cease requiring manufacturers to submit a separate request or form in addition to a priority review request.

“Applications requesting priority review will be screened in accordance with the standard 15 -day performance target, but reviewed in priority” when the specified criteria are met, Health Canada clarified. Industry can submit comments in response to the proposed changes until 25 January 2019.

Notice of Intent – Health Canada to confirm its priority review request process of medical device applications and eligibility criteria

Source: RAPS