Regulatory:

Effective January 31, 2003 Health Canada legislated that all manufacturers of Class II, III, & IV medical devices must first be ISO 13485:2003 registered before receiving approval in granting a device licence for their product.  Failure, by a manufacturer, to achieve the necessary ISO 13485:2003 designation renders their product illegal for sale in Canada.  “Health Canada advises that medical devices that are not licensed for sale in Canada must not be imported or purchased by health care facilities or consumers.”  (see “Medical Device Licence Listing”, www.mdall.ca)

As a responsible distributor of medical devices in Canada, Canadian Hospital Specialties is steadfast in its commitment to quality and regulatory compliance.  CHS completes all required due diligence in representing our suppliers’ devices and ensures their manufacturers do the same.  We encourage our customers to audit their suppliers to ensure compliance with Health Canada’s decree.

Health Canada’s user-friendly interactive database is located at www.mdall.ca.  Follow the links to the search page – here you can search by “Company Name” (manufacturer name), “Licence Name”, “Device Name” (product description), “Company ID”, “Licence Number”, or “Device Identifier” (product number).  All legal devices of risk class II, III, or IV for sale in Canada are listed.