Licensing Controls Integral Part of Canada’s Risk Inspections

Manufacturers must have controls to ensure the proper licensing of Class II, III and IV devices imported, advertised or sold in Canada, according to a final guidance. The validity of the licenses will be verified by reviewing a company’s current license, device catalogue and advertising materials, the guidance by Health Canada’s Health Products and Food Branch Inspectorate says. The guidance, which became effective this month, does not apply to custom-made, special access and investigational devices.
International Medical Device Regulatory Monitor