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Healthcare Resource Guide: Canada

 

CANADA Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Barriers

Trade Events

 

Capital: Ottawa

Population:36,048,521

GDP: USD 1.592 trillion (est. 2016)

Currency: Canadian Dollar (CAD)

Language: English and French

Summary:

Canada’s health care industry depends heavily on the demand created by the country’s publicly funded and insured health care system. The medical device industry consists of firms that produce a wide range of products used for diagnosis and treatment of ailments, which include the following: medical, surgical and dental equipment (including electro-medical equipment and related software), furniture, supplies and consumables, orthopedic appliances, prosthetics and diagnostic kits, reagent and equipment.

The Canadian healthcare system falls under the jurisdiction of each province and territory. While funding is subsidized through federal transfer payments, the delivery and management of healthcare services are controlled by the provincial governments. Healthcare systems in Canada use various competitive tendering processes for the procurement of medical devices and diagnostics technologies. These change depending on the province, but are generally conducted by each hospital and depend on the need and resources available to the hospital.

The Canadian medical device market was valued at approximately USD$8 billion in 2014, making it the ninth largest market in the world. Canada’s medical device imports totaled approximately USD$6.3 billion in 2014. The United States is the biggest exporter of medical devices to Canada, accounting for approximately 45 percent of imports, or nearly USD$3 billion.

Currently, 80 percent of the Canadian medical device market is comprised of imported goods. There is particular demand for diagnostic equipment, as well as consumables, patient aids, orthopedic and prosthetic equipment, and dental equipment. The orthopedic and prosthetic equipment subsector is experiencing the strongest growth.

There are nearly 1,500 manufacturers of medical devices in Canada, employing approximately 35,000 people across the country. The three largest markets of the industry are respectively, Ontario, Quebec and British Columbia.

Medical device manufacturers should develop partnerships with Canadian distributors to sell their products. To do this, they must obtain an establishment license and, if necessary, a device license. Imported medical devices are subject to Canadian safety and effectiveness regulations and packaging requirements. Few other barriers exist for U.S. businesses looking to sell in Canada. According to BMI’s Medical Device Risk/Reward Index (RRI), Canada is one of the most attractive markets in the Americas for commercializing a medical device.

Market Entry

Health Canada, under the authority of the Food and Drugs Act, regulates the sale of medical devices in Canada. Health Canada is an equivalent regulatory agency to the U.S. Food and Drug Administration (FDA). Medical equipment imports must comply with marking, labeling, and packaging requirements as described in the Food and Drug Act. In particular, instructions (operator’s manual) accompanying the equipment must be in both of Canada’s official languages (English and French).

Current Market Trends:

Hospitals and other public health institutions are the principal purchasers of medical equipment and supplies, accounting for about 70 percent of total market demand in Canada. These organizations buy directly from manufacturers for capital equipment and use group procurement and distribution for regular medical equipment including devices, instruments, and supplies.

The demand for diagnostic equipment accounted for approximately 51 percent of the total medical devices imports in 2015, which includes technologies such as nuclear medicine cameras, MRI (magnetic resonance imaging), and CT (computed tomography). Other medical electro-diagnostic and patient monitoring equipment, including ultraviolet or infrared rays and ultrasonic scanners, will also see an increased demand. Other top US contributors to the medical device import market in 2015 were instruments & appliances (52.4%), bougies, catheters, drains, and parts (50.8%), and artificial parts of the body (52.4%).

Main Competitors:

The United States is by far the biggest exporter of medical devices to Canada, accounting for approximately 45 percent of the country’s medical device imports. Other key import sources include Switzerland (13 percent), Germany (8.6 percent), and United Kingdom (5.3 percent).

Current Demand:

The Canadian medical device market depends upon imports for about 80 percent of its consumption. The import market is expected to grow at a 4.4 percent rate through 2016. Orthopedic and prosthetic equipment imports are projected to expand at growth rate of 8.3 percent, while demand for all other medical device categories are expected to grow by at least 3 percent per year.

Canada’s elderly population continues to grow. In 2015, nearly 16.1% of Canadians were at least 65 years of age or older. According to the most recent population projections, the share of persons aged 65 years and older will continue to increase and should account for nearly twenty-one percent of the population in 2024. This rapid aging of the population presents a key market opportunity for businesses in the medical device industry.

Registration Process:

Canadian authorities have worked at harmonizing regulations with those of the United States and Europe by listing medical devices in the Medical Device Active License Listing (MDALL). In keeping with international trends, medical devices are regulated under the Food and Drugs Act as Class I (low risk), II, III or IV (high risk) devices, subject to Health Canada approval. All medical devices require an establishment license, and Class II, III and IV devices require a device license. All products are subject to safety and effectiveness requirements, including Class I devices, and these requirements must be satisfied with objective and documented evidence. It is important to conduct regular verification when considering the purchase of a medical device since medical device licenses can be suspended by Health Canada, cancelled during the annual renewal of licenses by Health Canada, or discontinued by the manufacturer.

Barriers:

Trade in the medical device market presents a number of advantages to U.S. firms. U.S. firms benefit from similarities between U.S. and Canadian regulations concerning the safety and quality of medical devices. Other advantages include: the similarity between general business practices, the established reputation of U.S. firms in Canada, and the close geographic proximity to Canada. Partnerships with the provincial and territorial health authorities responsible for the delivery of health care services are essential for the importing success of medical devices.

Trade Events:

Pharmaceutical Market Research Conference Canada 2016

June 22-23, 2016 Toronto, Ontario

The Pharma Market Research Conference is a two-day conference for pharmaceutical, biotechnology, medical device, and diagnostic market research executives. This conference has been established as the industry leader in the Canadian market. This conference would also be of interest to consulting organizations, agencies, software/technology vendors, and other service providers working in the healthcare sector.

For more information, visit: http://canada.pharmamarketresearchconference.com/

4th Annual National Forum on Patient Experience

September 20-21, 2016 Toronto, Ontario

The 4th National Forum includes topics such as digitizing a patient’s ability to make medical appointments, using data analysis to measure patient experience and social media to increase patient engagement. Everything from easy access to digital healthcare records, communication with doctors via webcam and apps used to monitor conditions, can enhance the patient experience. Speakers include from Thunder Bay Regional Health Sciences Centre, Sunnybrook, Mount Sinai, Accreditation Canada, London Health Sciences Centre, CIHI and more than 100 healthcare leaders worldwide.

For more information, visit: http://www.patientexperiencesummit.com

HealthAchieve

November 7-9, 2016 Toronto, Ontario

The largest health care gathering in Canada. It provides a conference program with educational sessions along with an exhibition floor hosting 350 exhibitors showcasing health products, services and technologies. HealthAchieve attracts around 9,000 delegates annually.

For more information, visit: http://www.healthachieve.com/

e-Health 2017

June 4-7, 2017 Location: TBD

e-Health offers proactive top-quality learning, opportunities to network directly with organizations members of the health informatics community that value quality health information as well as effective integrated system solutions. Since its inception, the Conference has attracted a steadily increasing attendance, now upwards of 1,500+ delegates.

Government Links:

Health Canada (http://www.hc-sc.gc.ca/index-eng.php)

Healthcare Procurement:

Merx: Canadian Public Tenders (http://www.merx.com/)

SEAO: Official Tendering Site of the Government of Québec (https://www.seao.ca/)

Canada’s Healthcare Procurement Services Organization - HealthPro Link: http://portal.healthprocanada.com/

Government Health Plans (by province):

Québec: Régie de l’Assurance Maladie du Québec (http://www.ramq.gouv.qc.ca/en/Pages/home.aspx)

Ontario: Ministry of Health and Long-Term Care

(http://www.health.gov.on.ca/en/)

British Columbia: B.C. Health

(http://www2.gov.bc.ca/gov/content/health)

Manitoba: Manitoba Health, Healthy Living and Seniors

(http://www.gov.mb.ca/health/)

Saskatchewan: eHealth Saskatchewan

(http://www.ehealthsask.ca/Pages/default.aspx)

Alberta: Alberta Health

(http://www.health.alberta.ca/default.html)

New Brunswick: New Brunswick Health

(http://www2.gnb.ca/content/gnb/en/departments/health.html)

Nova Scotia: Nova Scotia Department of Wellness

(http://novascotia.ca/DHW/)

Prince Edward Island: Health PEI

(http://www.healthpei.ca/)

Newfoundland & Labrador: Department of Health and Community Services

(http://www.health.gov.nl.ca/health/)

Yukon: Health & Social Services

(http://www.hss.gov.yk.ca/)

Nunavut: Department of Health

(http://www.gov.nu.ca/health)

Northwest Territories: Health & Social Services

(http://www.hss.gov.nt.ca/)

U.S. Commercial Service Contact Information

Name: Connie Irrera

Position: Health Sector Specialist

Email: connie.irrera@trade.gov

Phone: 514-908-3662


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