Selling 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

Our Medical Devices Directorate (formerly the Medical Devices Bureau) helps to ensure the safety, effectiveness and quality of medical devices sold in Canada. The Medical Devices and Clinical Compliance Directorate in the Regional Operations and …

Frequently asked questions: Medical device establishment

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.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). …

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

Special Access Program (SAP) for Drugs and Medical Devices not available in Canada: The Special Access Program (SAP), via exemptions set out in …

Frequently Asked Questions - Medical Devices Regulations

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html

There are several types of applications for authorization under the Medical Devices Regulations: Class II medical device licence; Class III medical device licence; Class IV …

Selling Medical Devices in Canada - Distributor? Private Label?

https://elsmar.com/elsmarqualityforum/threads/selling-medical-devices-in-canada-distributor-private-label.73617/

Selling Medical Device Components to US hospitals and doctors: US Food and Drug Administration (FDA) 4: Jun 19, 2019: R: Medical Device (IVD) - Selling RUO …

Selling from the U.S. to Canada Sales Tax Obligations

https://baranovcpa.ca/selling-from-us-to-canada-sales-tax/

In this article, we will discuss when and what taxes you should charge when selling from the U.S. to Canada. First, let’s go over some quick definitions: GST = Goods and Services Tax – 5% sales tax …

Shipping Medical Devices To Canada: What You Need …

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

Shipping Medical Devices to Canada with R+L Global Logistics. Getting medical devices across the border can be a difficult task. R+L Global Logistics understands the challenges of shipping goods and …

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, …

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

Special Access Program (SAP) for Drugs and Medical Devices not available in Canada: The Special Access Program (SAP), via exemptions set out in C.08.010 and C.08.011 of the …