THE MEDICAL SECTOR IN CANADA

The Medical Device Sector

Canada: A Strategic Market for Medical Devices and Health Innovation

For several years, Canada has been attracting international players in the medical sector, particularly those specializing in medical devices. With a structured healthcare system, an aging population, and a strong commitment to independence in health technologies, the country represents a market that is both promising and demanding.

Canada at a glance :

A Structured but Decentralized Healthcare System

Canada provides universal access to healthcare through its public system (Medicare), which is administered at the provincial level. Each province manages its own budgets, priorities, and procurement programs, making the commercial approach more complex for foreign companies. At the same time, these regional structures create opportunities for partnerships and offer a diversity of entry points.

A Rapidly Evolving Medical Devices Market in Canada

Canada’s medical devices sector is both vast and dynamic. It brings together public and private players: hospitals, research centers, clinics, specialized distributors, and a growing network of digital health start-ups. The most in-demand products range from surgical instruments and imaging equipment to connected devices.

Supported by clusters and university-based centers, the country has fostered an environment conducive to research and R&D funding.

In this context, innovations in telemedicine, IoT-based devices, and remote monitoring tools are gaining traction, driven by the digital transformation of healthcare. The pandemic accelerated these trends while also exposing the risks of reliance on imports. This includes telemedicine, diagnostics, and AI-driven therapeutics—particularly critical given Canada’s shortage of healthcare professionals, especially in remote regions. As a result, Canadian governments are investing in local production and technological partnerships.

Health Canada Regulation: Rigorous yet Transparent

Entering the Canadian market requires approval from Health Canada, with devices classified according to their risk level. Unlike in Europe, CE marking alone is not sufficient: a specific process is required, sometimes involving audits, CSA/UL certifications, and bilingual labeling requirements. While these steps may slow down market entry, they provide a framework of trust for end users.

Medical devices are classified under Health Canada’s risk-based system into four categories — Class I, II, III, and IV. Licenses for Class I devices are relatively easy to obtain. Class II devices require an MDSAP certificate, while Classes III and IV involve a more complex process. However, obtaining a license in Canada is generally less time-consuming than under the EU MDR regulation.

Challenges	Solutions	Associated Opportunities
Shortages of specialized healthcare workers, particularly in nursing, imaging, and biomedical fields	International recruitment, government incentives, increased use of telehealth and automation	Remote training, support technologies (AI, robotics), deployment of digital healthcare services
Accessibility of equipment for people with disabilities (recurring issue, especially outside major centers)	Strengthened accessibility standards, innovation in universal design	Development of inclusive equipment, niche markets for specialized companies
Increasing complexity of medical needs (aging population, chronic diseases, personalized care)	Interprofessional coordination, decision-support tools, integration of health data	Digital health platforms, AI for diagnostics, customized solutions
Geographic remoteness	Telemedicine, mobile clinics, medical drones	Specialized logistics solutions, niche markets (e.g., Indigenous healthcare, northern health services)
Need for innovation and adaptation of healthcare infrastructure	Increased public funding, PPPs, calls for innovation	Equipment modernization, smart hospital construction, sustainable healthcare buildings
Inefficient management in some regions (persistent disparities across provinces and rural areas)	Centralization of data, best practice sharing, smart regionalization	Outsourced services, public-private partnerships, AI-driven optimization

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How Adexia Supports Medical Companies in their development in Canada

We provide support at every stage of the journey: strategic market analysis, regulatory assessment, partner identification, subsidiary creation, V.I.E. programs, and employee hosting solutions. Our one-stop service, dedicated to healthcare companies, ensures a progressive, controlled, and market-adapted entry into Canada.

The Pharmaceutical Sector

The pharmaceutical sector in Canada is an important and steadily growing economic player. It ranks 6th globally, with a 2.1% share of the world market. Since 2018, it has seen a positive compound annual growth rate of 7.5%. In 2024, the sector employs around 35,000 people, with a geographic concentration in the metropolitan regions of Toronto, Montréal, and Vancouver.

Structure of the Pharmaceutical Market in Canada

• Manufacturing : Major international laboratories (Pfizer, Novartis, Sanofi, GSK, etc.) are present alongside Canadian companies (Bausch Health, Apotex, Valeo Pharma). The industry is heavily concentrated in Ontario and Québec, which account for over 85% of production and employment.

• Distribution : Main distributors include McKesson Canada, Shoppers Drug Mart (Loblaw), Jean Coutu (Métro), etc. The country also has a network of more than 11,000 community pharmacies.

• Generic Drugs and Biosimilars : Canada is a key market for generics (Apotex, Teva Canada, Sandoz Canada). Biosimilars are rapidly gaining ground thanks to public substitution policies.

  
  

Regulatory Process for Market Entry of a Drug in Canada

The process is governed by the Food and Drugs Act (FDA) and its regulations, and overseen by Health Canada through the Health Products and Food Branch (HPFB).

To be authorized for sale, a sponsor must submit a New Drug Submission (NDS) or, in the case of generics, an Abbreviated New Drug Submission (ANDS). The application must include complete data on quality, manufacturing, safety, efficacy (clinical trials), labeling, risks, and benefits. Health Canada carefully evaluates the drug according to these criteria before granting or refusing a Notice of Compliance (NOC) and a Drug Identification Number (DIN). No drug may be marketed without prior approval from Health Canada.

The review process can take between 6 months and 2 years, depending on the nature of the drug and the data provided. Once authorized, drugs are continuously monitored for safety and effectiveness on the market.

Various other regulations cover manufacturing, storage, distribution, and marketing (including site licenses for pharmaceutical products).

If rejected, the sponsor may provide additional information, resubmit, or request a review. The process can be streamlined with strong documentation and collaboration with Canadian regulatory experts.

The prices of patented drugs are controlled by the PMPRB (Patented Medicine Prices Review Board), and each province manages its own public drug insurance program (e.g., RAMQ in Québec, Ontario Drug Benefit).

Trends & Opportunities

• Biotechnology and Innovative Therapies: sustained growth in biopharmaceuticals, vaccines, and gene therapies.

• Clinical Research: Canada is an attractive hub for clinical trials, thanks to its world-class hospital and university infrastructure.

• Local Production: following the pandemic, there is a growing drive to strengthen Canadian manufacturing of essential medicines.

Challenges

• High prices of patented drugs, compared to other OECD countries.

• Pressure on public financing due to an aging population.

• Drug shortages, a recurring issue for some essential products.

• International competitiveness: Canada invests less in pharmaceutical R&D than markets such as the United States or Europe.

The pharmaceutical sector in Canada remains strong, with a strong presence in Ontario and Québec. It is characterized by the dominance of multinational corporations, but also by the dynamism of local players specializing in generics and biotechnology. Despite challenges related to costs and supply, the sector offers promising opportunities in innovation, biosimilars, and local production.

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