Canadian device user fees would take effect Sept. 1 under proposed reg.
This article was originally published in The Gray Sheet
CANADIAN DEVICE PREMARKET SUBMISSIONS EXPECTED TO DROP AS MUCH AS 41.7% for "Part V" products following implementa-tion of a device user fee program, according to an economic impact study commissioned by Canada's Medical Devices Bureau (MDB) and conducted by Armar International. According to the study, which surveyed Canadian device manufacturers, the average decrease in premarket submissions and supplements under Part V of Canadian device law could be "as high as" 41.7% due to user fee expenses. MDB typically receives about 240 Part V submission a year; a 41.7% drop would reduce the number to 101.
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