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From January 1st, 2003, a new medical device regulation, Canada medical device law is put into practice. All medical devices sold in Canada, no matter local or imported, should get the permission of Canada medical device competent department in Health Canada. Different from American FDA government, CMDCAS (Canadian Medical Devices Conformity Assessment System) registration law contains product registration and GMP certification, as well as the third party Notified Body CE certification in Europe and quality system certification of Canada government registration combine with the third party. The third party is referred to as the body which is recognized by CMDCAS. CMDCAS can be divided into 4 classes according to their risk: class one with the lowest risk, class four with the highest. CMDCAS certification point: In the certification, aside from obeying quality management system of ISO 13485/8:1996 or ISO 13485:2003 standard, on-site evidence must meet CMDR requirements.
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