Medical Device Licence Application Review

Medical Device Licence Application Review Fees as of April 1, 2019
Fee Category Description Fee as of April 1, 2018 Fee as of April 1, 2019
Class II - Licence Application $405 $414
Class III - Licence Application $5,805 $5,922
Class III - Licence Application (Near Patient In Vitro Diagnostic Devices) $9,881 $10,079
Class IV - Licence Application $13,500 $13,770
Class IV - Licence Application (Devices that contain human / animal tissue) $12,594 $12,846
Class IV - Licence Application (Near Patient In Vitro Diagnostic Devices) $23,012 $23,473
Class III - Changes in Manufacturing Changes in manufacturing processes, facility, equipment or quality control procedures $1,462 $1,492
Class IV - Changes in Manufacturing $1,462 $1,492
Class III - Significant Changes (not related to Manufacturing) $5,437 $5,546
Class IV - Significant Change (not related to Manufacturing $6,195 $6,319
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