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Canadian Medical Devices Regulations
Health Canada is the first national regulatory body to require a specific quality systems standard, ISO 13485, as a prerequisite to device licensing requirements necessary to conduct business in Canada.
To help your organization achieve entry to the Canadian marketplace, TÜV SÜD America has created this comprehensive information center to provide important details regarding the regulatory requirements for medical devices in Canada.
On November 1, 2003, Canadian Law required manufacturers of class II, III and IV medical devices to have a quality management system that meets the requirements of ISO 13485 in order to obtain a license to sell their devices in Canada. Only an ISO 13485 certificate issued by an SCC-qualified CMDCAS Registrar will be accepted. Manufacturers must submit the appropriate certificate with their annual renewal applications.
Effective March 15, 2006 Health Canada no longer accepts new license applications unless an organization has an SCC-accredited ISO 13485:2003 certificate. All ISO 13485/88:1996 certificates will become invalid after July 15, 2006.
Prepare your organization by visiting the following links, which provide helpful information needed to meet the requirements of the Canadian Medical Devices Regulations.
For more information, contact us.