ARGO Customs Helps Canadian Importers Adhere to Medical Device Licensing Regulations

Medical Device Licensing Regulations

May 21, 2020 – Toronto, ON – A recent regulation change from the Canadian Border Services Agency (CBSA) reduced or eliminated duties on a wide range of medical products – however, to take advantage of these benefits, an importer must be properly licensed to import medical supplies.  The experts at ARGO Customs want to help importers understand the regulations, and how to qualify as a medical device importer.

The CBSA has four classifications for medical products and devices, from Class I to Class IV.  The class indicates the potential danger or hazards associated with the product.  For example, a basic oral thermometer is Class I, while a pacemaker is Class IV.  Devices from Class II, III, and IV must be licensed, while Class I product importation is less restricted.

To import Class I medical supplies, an importer must only have a Medical Device Establishment License (MDEL), which guarantees they have reliable sources and products.  For devices in Classes II – IV, a stricter Medical Device License (MDL) is required.  Application for these licenses can require substantial paperwork and proof of safety.

There are also several exemptions to the Class I MDEL licensing requirements on importation including:

  • Devices imported by individuals for their own personal use
  • Supplies imported directly by registered health care facilities
  • Operators of registered dispensaries which provide medical goods to the public
  • Anyone importing medical supplies or devices intended only for animals
  • Warehouses which only store devices, without selling or trading them

Having the proper licensing is imperative for a company’s products to be successfully imported, otherwise, they may be held at the border indefinitely or even ejected from the company.  ARGO Customs suggests that importers partner with an experienced customs broker to simplify the process.

About ARGO Customs

ARGO Customs employs highly experienced global trade specialists to help ease the flow of goods into and out of Canada.  Regardless of the size of the shipment or the companies involved, ARGO will work tirelessly to reduce regulatory difficulties and see the shipment delivered in a minimal timeframe.

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