Overview  

Canada’s medical device market ranks as the eighth largest in the world, with an estimated value of US$9.8 billion in 2024 and projected growth reaching nearly US$13.5 billion by 2028. The sector is expected to expand at a compound annual growth rate of 5.5%, driven by increased healthcare demand, technological innovation, and an aging population.  

The industry is highly diversified, comprised mostly of small and medium-sized enterprises engaged in the research, development, manufacturing and distribution of medical, diagnostic, and therapeutic devices. More than 1,500 medical device companies operate in Canada.

Core segments include diagnostic imaging (HS-9018), orthopedics (HS-9021), surgical instruments (HS-9018) with rising investment in smart medical devices, robotics, and AI-powered diagnostics. Medical device companies are located across Canada and are primarily concentrated in the three largest provinces, Ontario, Quebec and British Columbia.  Approximately 46.8% of all Canadian medical device companies are in Ontario, while 22.3% are based in Quebec. The largest markets for export are the United States, Europe, Middle East, South America and China.  

While Canada is working to strengthen its domestic manufacturing base through national biomanufacturing and innovation strategies, the market remains heavily reliant on imports, especially from the States, which supplies nearly 40% of all medical device imports. With ongoing federal and provincial healthcare investments and a strong regulatory framework aligned with international standards, Canada offers a stable and attractive environment for U.S. exporters and MedTech innovators.  

U.S. exporters need to be aware that all medical devices are regulated by Health Canada’s Medical Device Bureau of the Therapeutic Products Directorate and governed by Canada’s Food and Drugs Act and Medical Device Regulations. Under these laws, all medical devices are categorized in four classes and manufacturers for class II, III, and IV need to hold a Canadian Medical Device License (MDL) and be certified through the Medical Device Single Audit Program (MDSAP) to maintain a medical device license.

In the Canadian healthcare system, the federal government sets and administers national standards through the Canada Health Act, while provincial and territorial governments are responsible for the management, organization, and delivery of healthcare services to their residents. Federal health funding is provided primarily through the Canadian Health Transfer (CHT), a fiscal year-based payment that supports provincial healthcare systems. Although the CHT is a block transfer, provinces and territories negotiate its size and allocation with the federal government, ensuring alignment with regional health priorities.    

In 2024, Canada’s average healthcare spending person was approximately CAD$9,054 (US$6,500) with notable variation across provinces due to differing demographics, healthcare priorities, and provincial budgets. This level of expenditure supports sustained demand for medical technologies, with provinces investing in diagnostic equipment, surgical tools, and digital health solutions to improve patient outcomes and manage aging populations- driving growth and procurement opportunities in the medical device sector. See the chart below for a provincial breakdown.    

Table 1: Estimated Health Spending per Person by Province in Canada, 2024 
 

Data Source: Canadian Institute for Health Information (Nov 2024) 

Table 2: Medical Device Exports, Imports, Trade Surplus  

Data Source: Statistics Canada and U.S. Census Bureau (2025) and Bank of Canada (2025) 

Labeling and Language Requirements in Canada and Quebec

Medical devices sold in Canada must be labeled in either English or French, in accordance with federal regulations. U.S. exporters should be aware that the province of Quebec enforces stricter language requirements under its Charger of the French Language (Bill 96), which governs product labeling, marketing, and documentation.  

While Quebec’s language laws generally require French to appear on all products and accompanying materials, there is an important exception relevant to medical, pharmaceutical, and scientific products under Article 6 of the “Regulation Respecting the Language of Commerce and Business”.  

According to this exception, an inscription on a product from outside Quebec to be used for medical, pharmaceutical, or scientific purposes or an inscription on the container of such a product may be exclusively in a language other than French provided that the French version of the inscription appears on the wrapping of the product or on a document supplied with the product and either of the following conditions is met: (1) the product is not offered in Quebec for retail sale and no equivalent substitute presented in French is available in Quebec; or (2) the product weights 100 g or less or its container has a capacity of 10 cm or less or 10 ml or less.  

U.S. medical device manufacturers exporting to Quebec are strongly advised to consult with local legal or regulatory experts to ensure compliance with evolving language laws, especially in light of Bill 96, which continues to broaden the scope of French-language requirements in the commercial sector.  

Leading Sub-Sector

Virtual Care and Digitalization 

Canada’s telehealth market was already experiencing steady growth prior to the COVID-19 pandemic, and in 2025 it is expanding a rate of 32%. This growth is projected to accelerate to 37% by 2029, driven by the increasing demand for accessible healthcare in rural and remote communities and the growing mainstream adoption of virtual care services across the country. The current market size of this subsector stands at US$2.5 billion, and it will increase by another one billion dollars in the next four years. One risk to providing virtual care is the lack of compatibility across provinces, so the difference in regulation between geographic areas must be considered when designing and exporting to Canada.   

With macroeconomic trends, like advanced technologies and AI, digital medicine is a sub-sector of the healthcare industry that is also experiencing substantial growth. Digital medicine includes the production of medical devices that combine hardware and software to measure, intervene, and diagnose medical ailments. Digital software aims to innovate medical experience by targeting three healthcare segments.

First, it aims to create a flow of data that can give high-speed results to patients and doctors, both in and out of medical facilities. Second, digital medicine aims to be non-human readable technology, producing algorithms to run on large samples of data that cannot be analyzed by a medical professional. Third, examine genomic sequencing and future predictions of abnormal heart conditions. Lastly, digital medicine aims to share medical diagnoses with some room for doctors to correct false positive/negative data in real-time. Digital medicine devices, depending on the function of the product, could be classified under diagnostic apparatus or patient aid services which are leading sub-sectors. 

The larger environmental trend of personalization within products is also affecting the healthcare industry. Utilizing data analytics and AI will allow medical devices to be more personalized and accurate to the individual patient. These advances in technology are due to an increased public and private investment to drive predictive, preventative, and personalized medicine.  

Opportunities 

The Canadian market presents significant opportunities for U.S. exporters of medical devices, with the U.S. being Canada’s largest trading partner for this sector. Total imports of medical devices satisfy approximately 70% of domestic demand. In 2024, the United States remained the leading supplier of medical devices to the Canadian market, totaling US$1.4 billion representing nearly 40% of total imports in this sector. China was the next largest exporter at US$650 million representing 8.61%. Top imports include cardiology devices which make up 14% of the market, followed by diagnostic imaging (10%), orthopedic (9%) dental (8%), ophthalmic devices (8%), and diabetes care (6%). 

Table 3: Canada’s Medical Device Market Size in USD billion by Product (Statista, 2024)

Opportunities in the healthcare industry concerning medical devices are led by macroeconomic environmental trends. The six macro trends to take into consideration are demographic, economic, political, ecological, socio-cultural, and technological. In terms of demographics Canada has an aging population, which provides an opportunity to focus on medical devices to aid older population groups. 

Important economic trends include high inflation and supply chain issues, which allow U.S.  companies to increase exports to Canada due to geographical proximity. Canadian medical device companies are therefore anticipated to increase their reliance on strategic alliances and outsourcing for marketing, distribution, research, and manufacturing activities.   

In a post-pandemic environment, however, the aftermath of the economic strain put on the healthcare system has decreased public spending ability. Politically, with an increased focus on health, there are stricter regulations and best practices for healthcare products. Canada’s changing ecological environment is also essential when considering population movement and the geographical area to invest in medical supplies distribution. 

For Canadians, health and well-being is a top priority. U.S.  medical device companies will have to consider these cultural changes when designing medical devices. Finally, advances in technology, including a larger focus on data analytics and artificial intelligence (AI), will change where public investments are directed and allow the standards of diagnostic medicine to evolve.  
See chart below for a summary of major healthcare projects across Canada that are expected to generate significant opportunities for U.S. medical device suppliers.

Table 4: Major healthcare projects in Canada: 

Procurement 

Canada’s mixed public-private healthcare system is comprised of the public sector, which finances healthcare services and the private sector, which delivers these services. Procurement is mandated differently by each province. Provincial governments across Canada are currently implementing or exploring changes to healthcare procurement. 

Hospitals and other health care providers in Canada can procure their equipment, supplies, and services individually or as part of group purchasing (GPO) or shared services organizations (SSO). Hospitals alone account for an estimated 26.4% of total healthcare spending. Ontario and Quebec account for most of the industry, 29.3% of the country’s hospitals are in Ontario and 17.7% are in Quebec. Other significant buyers include medical professionals, such as dentists, eye-care specialists, and other professionals in nursing homes and residential care facilities. Private clinics and outpatient 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. (See link under Resources below).   

U.S. companies benefit from the provisions of the United States-Mexico-Canada Agreement (USMCA), which ensures non-discriminatory access to many public procurement opportunities.  Establishing local partnerships or having a Canadian representative can further strengthen competitiveness and facilitate compliance with local regulations.  

Resources:   

Major Events and Trade Shows in Canada 

• Medtech Conference, October 5-8, 2025, San Diego, California 
• E-health Annual Conference and Tradeshow, (dates for 2026 TBC), Vancouver, BC 
• WHX Miami (formerly FIME), June 17-19, 2026, Miami, Florida 
   

Canadian Government 

• Canada’s List of Tendering Sites by Province:   Tendering Sites:  
• Health Canada – Safe Medical Devices Canada 
• Health Canada – Software as a Medical Device (SaMD) 
   

Commercial Service 

For additional information on this sector, please contact Commercial Specialists, Connie Irrera, Life Sciences National Sector Specialist at Connie.Irrera@trade.gov - (514) 908-3662 or cell (514) 592-7871, and Abedin Kader, Ontario Life Sciences Specialist Abedin.Kader@trade.gov - (416) 595-5412 ext. 226 or cell (416) 451-9539.