Canada - Country Commercial Guide
Medical Devices

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-08-20

Overview

Canada has one of the largest economies in the world and the eighth largest medical device market. According to industry sources, this market was valued at approximately USD$8.6 billion in 2020.

Canada’s healthcare industry is experiencing demand increases resulting from the advance of chronic diseases and an aging population. The substitution of new and more expensive products, rising prices for existing products and more per-patient use of medical supplies continue to contribute to the industry’s growth. As the country shifts its focus towards emerging medical devices, technologies such as robotic surgery, surgical simulation, mobile health, and wearables are expected to experience significant growth.

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. Currently there is no consistent model for procurement across Canada. The rules are different in each province and are often different within regions or specific providers. Provincial governments across Canada are currently implementing or exploring changes to health care procurement—including centralization initiatives.

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% 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% of total imports due to geographic proximity and similarities in safety and quality standards between the two countries. The market is dominated by SMEs and the industry is primarily based in the three largest provinces, Ontario, Québec, and British Columbia.

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. A Canadian Medical Device License (MDL) is required for manufacturers selling Class II, III, or IV medical devices in Canada. As of 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.

Leading Sub-Sectors

· Diagnostic Apparatus

· Orthopedic

· Prosthetic

· Patient Monitoring

· Dental Equipment

Opportunities

Recent reports indicate that electronic health technologies will play a larger role in Canada healthcare spending including telehealth and the storage and transmission of electronic health records. Life science companies, patient advocacy organizations, informatics companies or technology firms will collaborate to improve the design and delivery of therapies. Major advances in technology are driving innovation in the Canadian medtech sector leading to the development and increased demand for connected medical devices that can generate, collect, analyze, and transmit data.

Virtual Care

The global COVID-19 pandemic created a momentum for expanding virtual healthcare options in Canada and this rise may continue in the long term due to customer preference towards its inherent convenience. U.S. suppliers and developers of solutions that give Canadians increased online access to health information will find opportunities in the Canadian market. Examples include portals that allow patients to book appointments online, websites which provide patient access to electronic medical records, lab results and platforms that connect patients with providers. In addition, mobile apps that give Canadians the ability to access healthcare remotely are all areas of growth. Remote patient monitoring and digital tools for mental health care are both growing sectors. Healthcare organizations seek multilingual digital health tools tailored to the needs of rural and indigenous communities.

Currently healthcare providers seek solutions to streamline healthcare operations, especially for scheduling and medical billing for virtual care. With the increasing use, transmission and storage of digital health information, providers need increased and more sophisticated cybersecurity protocols and encryption for the sake of patient privacy. Platforms that integrate with PrescribeIT, Canada’s countrywide e-prescription platform, could be an area of growth. Continuing education options via virtual delivery are also needed. Partnerships between U.S. and Canadian companies will be important since health data cannot be stored in servers outside of Canada or sent across the U.S./Canada border.

There is growing demand for home-based monitoring equipment used to virtually monitor a patient’s medical condition and securely transmit the data electronically to clinicians.

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 18.2% 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 80% of the medical device companies with buyers ranging from private to public health institutions.

Resources

Major Events and Trade Shows in Canada

· MedTech Conference (Virtual) (optional in-person opportunities in Washington, DC and Minneapolis, MN), September 27-30, 2021

· e-Health 2022 (Virtual) May 2022 (dates TBD)

Canadian Government

· Health Canada – Safe Medical Devices Canada

· Health Canada - Software as a Medical Device (SaMD)

Additional Information

· Canada Health Infoway

Commercial Service

For additional information on this sector, please contact Commercial Specialist Connie Irrera at Connie.Irrera@trade.gov or by phone at (514) 908-3662 or cell (514) 592-7871.