Importing Medical Devices Into Canada

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

Anyone who imports a medical device into Canada must also meet all applicable requirements of the FDA and associated Regulations. Some requirements include the following: Class I device: The importer must have a valid Medical Device Establishment …

Importing and exporting health products for commercial …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/commercial-use-health-products-guidance/document.html

Health Canada's Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees, GUI-0016, provides guidance on all …

Border requirements for importing and exporting health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/border-requirements-importing-exporting.html

Border requirements for importing and exporting health products (COVID-19) There is an unprecedented demand and urgent need for access to health products during the COVID …

Shipping Medical Devices To Canada: What …

https://canadacrossborderfreight.com/shipping-medical-devices-to-canada/

Shipping Medical Devices to Canada with R+L Global Logistics. Getting medical devices across the …

Bringing health products into Canada for personal use …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/personal-use-health-products-guidance/document.html

Guidance for exceptional importation and sale of medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/draft-guidance-exceptional-importation-sale-medical-devices.html

Importers, distributors and manufacturers seeking to import or sell designated medical devices in Canada must hold a valid medical device establishment licence (MDEL). …

Bringing health products into Canada for personal use …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/personal-use-health-products-guidance.html

This guidance document describes the rules for bringing health products into Canada for personal human and veterinary use. Health products include prescription …

Import Medical Supplies & Masks Into Canada | PCB

https://www.pcb.ca/industries-2/medical-supplies

If you are importing medical devices such as ventilators, bandages, face masks, wheelchairs, stethoscopes, hospital beds and the like into Canada, you must know what …

Memorandum D19-9-1 - The Administration of Health …

https://www.cbsa-asfc.gc.ca/publications/dm-md/d19/d19-9-1-eng.html

This memorandum amalgamates and updates Memorandum D19-9-1 Importation of Human Drugs, Natural Health Products and Medical Devices Regulated by the Food and Drugs …

FAQ's - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/frequently-asked-questions-importation-exportation-drugs-health-products.html

While it is recognized the dire need for drugs in distressed parts of the world, once the expiration date has passed there is no assurance that the drugs have the safety, …