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Drugs and Health Products

Medical Device Licence Application Review

Medical Device Licence Application Review Fees as of April 1, 2016
Fee Category Description Fee as of April 1, 2015 Fee as of April 1, 2016
Class II - Licence Application   $381 $389
Class III - Licence Application   $5,469 $5,579
Class III - Licence Application (Near Patient In Vitro Diagnostic Devices)   $9,310 $9,497
Class IV - Licence Application   $12,720 $12,975
Class IV - Licence Application (Devices that contain human / animal tissue)   $11,866 $12,104
Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices)   $21,683 $22,117
Class III - Changes in Manufacturing Changes in manufacturing processes, facility, equipment or quality control procedures $1,376 $1,404
Class IV - Changes in Manufacturing $1,376 $1,404
Class III - Significant Changes (not related to Manufacturing)   $5,122 $5,225
Class IV - Significant Change (not related to Manufacturing   $5,836 $5,953