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Drugs and Health Products

Medical Device Licence Application Review

Medical Device Licence Application Review Fees as of April 1, 2015
Fee Category Description Fee as of April 1, 2014 Fee as of April 1, 2015
Class II - Licence Application   $373 $381
Class III - Licence Application   $5,361 $5,469
Class III - Licence Application (Near Patient In Vitro Diagnostic Devices)   $9,127 $9,310
Class IV - Licence Application   $12,470 $12,720
Class IV - Licence Application (Devices that contain human / animal tissue)   $11,633 $11,866
Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices)   $21,257 $21,683
Class III - Changes in Manufacturing Changes in manufacturing processes, facility, equipment or quality control procedures $1,349 $1,376
Class IV - Changes in Manufacturing $1,349 $1,376
Class III - Significant Changes (not related to Manufacturing)   $5,021 $5,122
Class IV - Significant Change (not related to Manufacturing   $5,721 $5,836