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Drugs and Health Products

Medical Device Licence Application Review

Medical Device Licence Application Review Fees as of April 1, 2014
Fee Category Description Fee as of April 1, 2013 Fee as of April 1, 2014
Class II - Licence Application   $365 $373
Class III - Licence Application   $5,255 $5,361
Class III - Licence Application (Near Patient In Vitro Diagnostic Devices)   $8,948 $9,127
Class IV - Licence Application   $12,225 $12,470
Class IV - Licence Application (Devices that contain human / animal tissue)   $11,404 $11,633
Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices)   $20,840 $21,257
Class III - Changes in Manufacturing Changes in manufacturing processes, facility, equipment or quality control procedures $1,322 $1,349
Class IV - Changes in Manufacturing $1,322 $1,349
Class III - Significant Changes (not related to Manufacturing)   $4,922 $5,021
Class IV - Significant Change (not related to Manufacturing   $5,608 $5,721