
CMDCAS Registration and Certification C***ulting
FromJanuary1st,2003,anewmedicaldeviceregulation,Canadamedicaldevicelawisputintopractice.AllmedicaldevicessoldinCanada,nomatterlocalorimported,shouldgetthepermissionofCanadamedicaldevicecompetentdepartmentinHealthCanada.DifferentfromAmericanFDAgovernment,CMDCAS(CanadianMedicalDevicesConformityAsses***entSystem)registrationlawcontainsproductregistrationandGMPcertification,aswellasthethirdpartyNotifiedBodyCEcertificationinEuropeandqualitysystemcertificationofCanadagovernmentregistrationcombinewiththethirdparty.ThethirdpartyisreferredtoasthebodywhichisrecognizedbyCMDCAS.CMDCAScanbedividedinto4classesaccordingtotheirrisk:classonewiththelowestrisk,classfourwiththehighest.)