Canada

Since 1 Januar 2003 the Canadian legislator enjoins manufacturer of medical devices and in-vitro-devices of risk classes II, III and IV, who want to mark their products on the Canadian market, on quality management certificate according to ISO 13485. This certification according to ISO 13485 is obligatory since March 15th, 2006, for all manufacturer, who want to sell their products in Canada.

Accepted are only these certificates, which are issued by Standards Council of Canada (SCC) accredited Canadian Medical Devices Assessment System (CMDCAS) Registrar.

Our cooperation partner, DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen, is accredited as CMDCAS certification body for quality management systems. Our MEDCERT auditors are authorized to conduct audits of quality management system under CMDACS on behalf of DQS.