Under Health Canada’s Medical Device Regulations, all manufacturers of Class II, III and IV medical devices imported or sold in Canada must first obtain a Medical Device License. Manufacturers wishing to obtain a Medical Device License for distributing their devices in Canada must first attain a CAN/CSA ISO 13485 Quality System Certificate from a Health Canada recognized Third Party Registrar. In most cases, someone who imports into Canada, or sells in Canada, a medical device for human use requires an Establishment License. Manufacturers of Class I medical devices who sell those devices solely to the ultimate consumer are also required to obtain an Establishment License. Regulatory Insight has obtained numerous Medical Device Licenses and Establishment Licenses for its clients and can assist your company to obtain the same. Regulatory Insight can also help your company establish its quality system to be in full compliance with CAN/CSA ISO 13485 and can recommend a Third Party Registrar for issuance of your Quality System Certificate.