This is a best prospect industry sector for this country. Includes a market overview and trade data.
Last Published: 9/30/2019


Canada’s healthcare industry is experiencing demand increases resulting from the advance of chronic diseases and an aging population. In 2018, total healthcare expenditures were valued at approximately CDN$255 billion with a growth rate of approximately 4.2 percent. Government spending on healthcare exceeds eleven percent of Canada’s GDP. Most of this spending will be toward the three leading causes of death: cardiovascular, cancer and respiratory diseases.

Canada’s mixed public-private healthcare system comprises of the public sector, which finances healthcare services, and the private sector, which delivers these services. The Canadian healthcare system falls under the jurisdiction of each province and territory. As a result, the healthcare system differs by province in terms of structure, operation and procurement.

The Canadian medical device market is sophisticated and mature, with a strong demand for high-quality medical technologies. Medical device imports account for nearly 75 percent of the medical device market. The United States represents the leading supplier of medical devices to Canada, followed by China, Mexico and Germany. U.S. imports represent approximately 44 percent of total imports due to geographic proximity and similarities in safety and quality standards between the two countries.

Medical devices are regulated federally by Health Canada’s Medical Devices Bureau of the Therapeutic Products Directorate and governed by Canada’s Food and Drugs Act and Medical Device Regulations. Medical devices are categorized in four classes determined by applying the classification rules for medical devices. Class I represents the lowest perceived risk, and Class IV represents the highest perceived risk. A Canadian Medical Device License (MDL) is required for manufacturers selling Class II, III, or IV medical devices in Canada. On January 1, 2019, all medical devices with a Class II designation or higher require certification through the Medical Device Single Audit Program (MDSAP) to maintain and/or obtain a medical device license.

Industry sources indicate that in 2019 the Canadian medical device market was valued at approximately US$4.9 billion.

Table: Canada Medical Equipment Data (US$ Millions)





2019 (Estimated)

Total Local Production





Total Exports





Total Imports





Imports from the US





Total Market Size





(total market size = (total local production + imports) - exports)
US$ thousands / Exchange Rate:  US$1 = C$1.2957

Leading Sub-Sectors

Diagnostic apparatus, orthopedic, prosthetic, patient monitoring and dental equipment are Canada’s top five largest import categories.

Opportunities – AI in Healthcare

Recent reports indicate that the healthcare sector will experience growth in the use of digital technologies, increased use of real-world data (RWD) and new types of partnerships and collaborations. Life science companies, patient advocacy organizations, informatics companies or technology firms will collaborate to improve the design and delivery of therapies.
Artificial Intelligence (AI) will help physicians use more data points to make better informed treatment decisions. U.S. medical device manufacturers need to explore new avenues and look at collaboration with new-age technology companies to integrate and implement AI in products to stay ahead of competition, while addressing the current market needs.

The Canadian government is aware of the role automation and AI will play within its healthcare system. Health Canada is supporting the market emergence of current and future medical devices using a digital health technology to meet the growing demands, while ensuring that they remain safe and effective for Canadians. Under the Regulatory Review of Drugs and Devices initiative, Health Canada is establishing a new division within the Therapeutic Products Directorate’s Medical Devices Bureau to allow for a more targeted pre-market review of digital health technologies, to adapt to rapidly changing technologies in digital health and to respond to fast innovation cycles.


Hospitals and public health institutions are principle buyers of medical equipment and supplies. Hospitals alone account for an estimated 18.2 percent of total sales. Other significant buyers include medical professionals, such as dentists, eye care and other professionals in the nursing homes and residential care facilities. Private clinics and outpatient’s facilities are also experiencing a growing demand for medical equipment including devices, instruments and supplies.

Healthcare systems in Canada use various competitive tendering processes for the procurement of medical devices and equipment. U.S. suppliers looking to export to Canada should refer to the individual provinces’ tendering websites for information concerning procurement opportunities available in each province.

The provinces of Québec and Ontario host more than eighty percent of the medical device companies with buyers ranging from private to public health institutions. U.S. companies can review opportunities in these provinces by consulting the following websites: Québec –; Ontario –

Upcoming Events/Trade Shows 

Canada E-Health Conference
Toronto, Ontario
May 26-29, 2019

2nd HealthTech Connect
Toronto. Ontario
June 25, 2019

Web Resources

Health Canada – Safe Medical Devices Canada:
Health Canada – Regulatory Review of Drugs and Devices:
Health Canada - Software as a Medical Device (SaMD):
Québec Life Sciences Strategy:
Deloitte Canada:

For additional information on this sector, please contact Commercial Specialist Connie Irrera at, tel: (514) 908-3662

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting

More Information

Canada Medical Devices Trade Development and Promotion