Health Canada strictly regulates the import of medical devices into Canada. Medical devices imported into Canada for sale, with or without a monetary contribution, must meet Health Canada requirements for commercial importation, as outlined in the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR).
The importation of a medical device that requires direct oversight, operation, or administration by another person is a commercial importation. For instance, commercial importation of medical devices includes shipments to a retailer, distributor, or another commercial establishment. This also includes shipments to independent sales contractors and distributors or to health care practitioners for use in their practice.
According to Health Canada guidelines, an importer is any person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device coming into Canada. It is important to note that anyone who imports a medical device into Canada must also meet all applicable regulatory requirements.
The importer must have a valid Medical Device Establishment Licence (MDEL) with the activity of import and ensure that the company from whom they import (foreign distributor) has an MDEL that includes the appropriate licensable activities unless exempted. If medical devices do not conform with Health Canada regulations and requirements, they may be denied entry into Canada and may jeopardize your financial investment.
Save yourself the rigours of meeting the regulatory requirements to import your medical devices into Canada, use an MDEL Import Agent! An MDEL Import Agent resides in Canada, assists in communicating with Health Canada, responds to Health Canada’s questions regarding devices to be imported or already imported into Canada, undertakes mandatory inspections, and meets all regulatory requirements relating to medical device importation and sale in Canada. MDEL Import Agents are legally responsible for the medical devices in Canada and have extensive responsibilities under MDR.
As a foreign company that does not have a presence in Canada wants to enter the Canadian market, an MDEL Import Agent is able to register your products in Canada. Else way, a Canadian company may also use an MDEL Import agent especially when you want to offload the legal responsibilities relating to the importation of medical devices to professionals who understand and meet compliance requirements.
Importers should ensure that the device they are bringing into Canada is compliant with all the necessary regulations. The costs of non-compliance can be huge – in terms of monetary losses and reputational damage as well.
Save yourself the heavy cost of yearly licensing, yearly compliance, and regulatory requirements – import your devices stress-free! Have the professionals do the heavy lifting of executing the fine print included in regulatory requirements and avoid unnecessary delays and expenses.
We can also assist you with MDEL Registration, Medical Device Classification, IVD Device Registration, and Software as a Medial Device (SaMD) Classification and Registration.