Medical Device Licence Application Review

Medical Device Licence Application Review Fees as of April 1, 2017
Fee Category Description Fee as of April 1, 2016 Fee as of April 1, 2017
Class II - Licence Application $389 $397
Class III - Licence Application $5,579 $5,691
Class III - Licence Application (Near Patient In Vitro Diagnostic Devices) $9,497 $9,687
Class IV - Licence Application $12,975 $13,235
Class IV - Licence Application (Devices that contain human / animal tissue) $12,104 $12,347
Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices) $22,117 $22,560
Class III - Changes in Manufacturing Changes in manufacturing processes, facility, equipment or quality control procedures $1,404 $1,433
Class IV - Changes in Manufacturing $1,404 $1,433
Class III - Significant Changes (not related to Manufacturing) $5,225 $5,330
Class IV - Significant Change (not related to Manufacturing $5,953 $6,073
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