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Health Canada is the only entity that provides licenses for the sale of health and medical products in Canada.
An organization wishing to sell health or drug products in Canada should have a Medical Devices Establishment License for its business as well as Medical Device Licenses for each of its products (depending upon the classification).
Medical Devices Establishment Licenses
Health Canada encourages individuals and organizations to verify that companies selling products into Canada have licenses in place. This step is to avoid risk to organizations of unknowingly purchasing illegal products and can easily be completed by accessing Health Canada's Medical Devices Establishment License (MDEL) link to ensure that the manufacturer is listed as licensed. Health Canada takes licensing seriously as a risk mitigation strategy designed to protect Canadians. If Health Canada discovers that products are being distributed in Canada without licenses, then Health Canada has the option of issuing a "stop sale" order to the manufacturer or distributor and / or recalling all of the products in Canada. If there is any doubt that a company has a Medical Devices Establishment License issued by Health Canada, organizations should ask the product supplier for a copy of the license --and retain the copy for internal records.
Medical Device Licenses
Depending upon the type of medical product that a company is selling in Canada, the product may or may not require a Medical Device License. Health Canada designates unique Class distinctions for products or devices (Class I - Class IV), based upon the government's determination of potential risk to consumers. Using
Health Canada's MDEL link, individuals can see both the Medical Devices Establishment License for a health product supplier as well as the classifications of the products it sells in Canada. Class I devices are considered the least risky and Class 4 designated products are considered the most risky. Class I medical devices or products do not require a Medical Device License from Health Canada to be approved for sale in Canada. All other classes of medical devices or products require a Medical Device License for sale in Canada. Curious about Medical Device Licenses for current suppliers? Query them by using Health Canada's Medical Devices Active Licenses Listing (MDALL) link.
Pamco is a licensed company that sells products that are compliant and licensed in accordance with Health Canada guidelines. Recently, some U.S. companies have tried to sell products to Canadian health organizations citing FDA approval instead of Health Canada licenses. One example involves Dental Dams and Oral Barriers. In Canada, a Dental Dam is considered a Class I medical device and does not require a license. But unlike the FDA, Health Canada considers an Oral Barrier to be a Class III medical device --requiring a license. According to Health Canada, and despite product offerings, there are no Oral Barriers that are currently licensed for sale in Canada.
Mitigate the risk to consumers, and stay informed about health product suppliers' regulatory compliance, by verifying information online with Health Canada. | 
