Medical Devices

The Therapeutic Products Directorate (TPD) is the section of Health Canada that regulates this class of products in Canada. All products that carry a therapeutic claim and used as a device are considered Medical Device License must be registered for each Medical Device sold in Canada. Facilities that manufacture, package, label, import or distribute Medical Devices are required to have a current Medical Device Establishment License. The Medical Device needs to comply with current ISO quality management system standards. The Health Protection and Food Branch Inspectorate is the section of Health Canada that completes GMP audits of facilities that manufacture, import, package, label or distribute Medical Devices in Canada. They also review shipments referred by Canadian Border Services, and acts on trade and consumer complaints

Drug Products

The Therapeutic Products Directorate is the section of Health Canada that regulates this class of product in Canada. All products that carry a therapeutic claim and are excluded form the definition of a Natural Health Product are considered drugs. A Drug Identification Number (DIN) must be registered for all drug products sold in Canada. Facilities that manufacture, package, label, import or distribute drug products are required to have a current Establishment License that require compliance with the current Health Protection and Food Branch Inspectorate is the section of Health Canada that completes GMP audits of drug facilities, reviews shipments referred by Canada Customs, and acts on trade and consumer complaints.