THE MEDICAL SECTOR IN CANADA
- Audrey Calligaro
- Mar 26
- 6 min read
Updated: Oct 14
In today’s global landscape, where medical innovation and access to strategic markets are critical challenges, Medicallians, the first international alliance dedicated to the healthcare sector, brings together local experts to support medtech and biotech companies in their international growth.
As Medicallians’ representative member in Canada, Adexia uses this article to highlight the specificities and opportunities of both the medical device and pharmaceutical markets, helping healthcare players better understand this demanding yet highly promising environment.
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 publicly funded system, which is administered at the provincial level. At the federal level, Health Canada is responsible for protecting public health and setting the regulatory framework for the sector.
Provinces and territories manage and deliver most healthcare services, each with its own insurance plan, budgets, priorities, and purchasing programs. While this structure can make the market more complex for foreign companies to navigate, it also creates multiple entry points and valuable opportunities for regional partnerships.
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.
The Canadian medical device industry is highly diverse and not very concentrated. The vast majority of companies are small and medium-sized enterprises (SMEs). There are over 40,000 medical devices available in Canada, with about 75% of them being imported :
In 2024, the main commercial segments of the Canadian medical device market were as follows:
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.
Did you enjoy this article? Discover our other resources on international development and market trends to help you further your project in Canada!
How Adexia Supports Medical Companies in their development in Canada
We support companies at every stage of their journey: strategic analysis, regulatory review, partner search, subsidiary creation, V.I.E., and portage. Together with our expert regulatory partner, we also cover all aspects of compliance and standards, ensuring comprehensive and secure support. Our one-stop shop dedicated to healthcare companies enables a progressive, well-managed market entry, perfectly tailored to the requirements of the Canadian market.
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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.
The Pharmaceutical and Biopharmaceutical Sector in Canada
The sector is built on a highly collaborative ecosystem:
R&D and Innovation: strong presence of university research centers, teaching hospitals, and both public and private laboratories.
Clusters and Public Actors: organizations such as Montréal InVivo, Ontario Genomics, and MaRS bring together researchers, start-ups, multinationals, and investors.
Financing: access to government funding programs for research and development, as well as a robust ecosystem of venture capital, hedge funds, and institutional investors specialized in healthcare.
Hospitals and Teaching Hospitals: often the first partners and, ultimately, the direct clients in the adoption process of new therapies and technologies.
Regulation and Market Authorization
The approval process is governed by the Food and Drugs Act and overseen by Health Canada (Health Products and Food Branch).
To market a drug, the sponsor must submit a New Drug Submission (NDS) or an Abbreviated New Drug Submission (ANDS) for generics.
The submission must include data on quality, manufacturing, safety, efficacy (clinical trials), labeling, as well as a risk–benefit assessment.
If criteria are met, Health Canada issues a Notice of Compliance (NOC) and a Drug Identification Number (DIN).
The review process can take 6 months to 2 years, depending on the nature of the drug and the quality of the data provided.
Once approved, drugs are subject to ongoing post-market surveillance for safety and effectiveness.
Other Key Points
Specific licenses regulate the manufacturing, storage, distribution, and commercialization of pharmaceuticals.
The prices of patented medicines are regulated by the Patented Medicine Prices Review Board (PMPRB), while each province manages its own public drug insurance plan (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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