Shipping Medical Devices to Canada: What You Need to Know

Canada places a high value on its medical field, however, shipping medical devices into Canada can be a challenging task as there are strict standards and requirements that must be met, especially for cross-border freight. In 2017, the country spent over 242 billion dollars on the healthcare industry and that number is expected to rise significantly in the near future. Surprisingly, Canada receives the majority of its medical devices from other countries, with the United States being its largest contributor. The aging population has forced the government to increase spending on medical tools, otherwise known as medical devices.

You might be wondering, with restrictive limits, how does a company import medical devices into Canada? Many of these regulations come from the Food and Drugs Act (FDA). If medical devices are not in compliance with the FDA, Canada can ask that you return, dispose of, or relinquish your materials. With cross-border freight, it is important to have a skilled logistics partner that will help your product arrive without any error. Once you learn the basics, shipping medical devices to Canada will be something your business can do effortlessly. 

Canada Medical Device Classification

Canadians depend on medical devices to keep their health up to par. The devices are a multitude of instruments used in the health field for treatment, diagnosis, or prevention of diseases or irregular physical conditions.

Classification groups are used to categorize devices, determining the risk factor of each. Category I is considered low risk and category IV represents the highest risk. Classifications are determined by the use of the medical device. The risk factor constitutes the regulations the device will be held at for importation, the higher the risk the more strict the criteria are for importing the devices. 

Examples of devices within these categories include: 

• Category I (lowest risk) 
  • Surgical tools 
  • Bandages 
  • Culture media 
• Category II (low risk) 
  • Contacts 
  • Pregnancy tests 
  • Endoscopes 
  • Catheters 
• Category III (moderate risk) 
  • Orthopedic implants 
  • Glucose monitor 
  • Dental implants 
  • Dialysis machines 
• Category IV (high risk) 
  • Pacemakers 
  • Catheter angiogram 
  • Cranial shunt 

Canada Medical Device Regulations for Importation

Due to the rising elderly population, medical demands for Canada are increasing. The federal government spends more than ten percent of its Gross Domestic Product (GDP) on health necessities, that’s more than most countries in the world. 

Roughly 75 percent of Canada’s medical devices are imported. It receives the majority of its medical devices from the United States due to proximity and correlation in standards and procedures in the health field. The U.S. accounts for roughly 48 percent of the medical devices market in Canada. Mexico, China and Germany make up the other 27 percent. 

All health products crossing Canadian borders must be in compliance with the Food and Drugs Act (FDA) and its regulations including: 

• Labeling 
• Good Manufacturing Practices requirements (GMP) 
• Medical Device Establishment License (MDEL) 

Labeling 

For importation into Canada, medical devices must have a label and the label must be placed on the outside of the package for clear visibility. Additional requirements include: 

1. The products name 
2. Name of business and location 
3. The products identity - identifies the type of medical device, whether it belongs to a family or a test kit, specifies if the device is being imported for special access or is custom made
4. Category 3 and 4 devices are required to have a control number present on the label 
5. The components within the box, such as weight and size 
6. “Sterile” needs to be clearly written on the product if the device will be sold 
7. The expiration date, if it is needed
8. The directions and dangers of the product

All devices that are being sold for individual use must have directions in both English and French as part of The Canadian Consumer Packaging and Labeling Act. Products that do not meet labeling requirements will not be granted into the country.

Good Manufacturing Practices requirements (GMP)  

While it is not necessary for importers to have a registered quality system, it is required for the manufacturer. Canada will only accept certificates from the Canadian Medical Devices Conformity Assessment System (CMDCAS). After January 1, 2003, category 3 and 4 devices have quality system requirements under CAN/CSA ISO. This standard is responsible for ensuring the unification of medical devices throughout the country. 

Medical Device Establishment License (MDEL)

A manufacturer must obtain a Medical Device License (MDL) by the Medical Devices Bureau (MDB) of the Therapeutics Products Directorate in order to sell manufactured medical devices., However, this is not needed for imports. Distributors or importers are required to have an MDEL to pass the port of entry. The license is granted by the inspectorate once devices have been classified and inspected to ensure they meet the standards. 

An MDEL application must be completed and the associated fee must be paid in order to sell medical devices. An email will be sent out stating Health Canada received your application. However, it could take up to 120 days to hear back about the license. Your application can be approved earlier or later than that, but 120 days is the average time frame. If you are approved for the license you will be permitted to import and distribute medical devices in Canada. 

Annual reviews are considered a regulatory requirement to continue foreign trades, there is an additional fee for renewals. If you fail to submit the annual review your MDEL will be canceled as of April 1. 

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 medicine to Canada and we’re here to make the process simple for you and your business. Not only will we make your transition across the border smooth, we also offer services like supply chain management, warehousing and much more to simplify the journey. We also offer services in convenient locations such as Derby Line, Vermont. 

Our professional, knowledgeable, and multilingual logistics team will help you develop the best strategy for moving your freight. Contact us today at 855-915-0573 to receive a quote for shipping medical devices to Canada and get your freight to its destination promptly.