Healthcare Resource Guide: Canada

 

CANADA Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement

Barriers

Procurement & Tenders

Government Links

Trade Events

FAQs

Best Prospects

Statistics Snapshot

CS Contact

 

Capital: Ottawa

Population:35,151,728

GDP: USD 1.598 trillion (est. 2016)

Currency: Canadian Dollar (CAD)

Language: English and French

Summary

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. 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. As a result, the healthcare system differs by province in terms of structure and operation.

Canada’s healthcare industry is experiencing demand increases resulting from the advance of chronic diseases and an aging population. In 2016, total healthcare expenditures were valued at approximately CDN$228 billion. Healthcare spending in Canada is projected to increase from 2.7 percent to 7.5 percent by 2020. Much of this spending will be toward the three leading causes of death: cardiovascular, cancer and respiratory diseases.

The top five clusters of the Canadian medical industry are based in Alberta, Manitoba, Ontario, Quebec and British Colombia, with specific emphasis on the latter three. Over 80 percent of the medical device industry resides in the provinces of Ontario and Quebec.

Healthcare Policy Issues

Canada is a leading market for U.S. pharmaceutical exporters and among the top ten pharmaceutical markets globally due to a growing elderly population, high per capita pharmaceutical spending, and an advanced regulatory system. While recent Supreme Court rulings may improve intellectual property protection in Canada, the government has also proposed new regulations to lower prices for patented medicines by revising its reference pricing system, using pharmacoeconomic evaluations, and forcing companies to disclose confidential pricing agreements. There have not been significant changes to Canada’s market authorization and product certification requirements for medical devices since 2011. Health Canada, as part of its engagement with the International Medical Devices Regulators Forum, is working to align its information requirements for quality management systems with other regulators participating in the forum, in anticipation of one unified set of requirements recognized by Health Canada in late 2017.

Canada's Medical Device Sector

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 medical device industry is highly diversified, making it the ninth largest in the world. The market is sophisticated and mature, with developments in science and healthcare expected to contribute to the industry’s growth in the years ahead. The Canadian medical device industry employs over 35,000 people and is home to approximately 1500 corporate facilities. The industry is comprised of small, medium and large sized facilities. Large companies (100+ employees) represent 43 percent of the industry’s employment.

                                          

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. Instructions (operator’s manual) accompanying the equipment must be in both of Canada’s official languages (English and French).

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. Per BMI’s Medical Device Risk/Reward Index (RRI), Canada is one of the most attractive markets in the Americas for commercializing a medical device.

Hospitals and public health institutions are principle buyers of medical equipment and supplies. In 2016, hospitals alone accounted for an estimated 18.2 percent of total sales. However, as more hospitals continue to use Group Purchasing Organizations (GPOs), this will intensify price-based competition. This growing trend will give hospitals sufficient purchasing power to directly source products from manufacturers. 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.

Trade in the medical device market presents several 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 healthcare services are essential for the importing success of medical devices.

 

Current Market Trends

Rising demand and associated spending are caused by an aging population, the growing incidence of chronic diseases, development of costly clinical innovations, increasing patient awareness, knowledge, and expectations and continued economic uncertainty despite regional pockets of recovery. Industry experts report that the number of adults aged 65 and older, is expected to increase at an annual rate of 3.8 percent over the next five years. By 2021, seniors will comprise 18.7 percent of Canada’s population up from 16.5 percent in 2016. Devices that support the older population, including neurological and cardiovascular products are expected to experience strong sales over the next five years. Industry revenue is expected to grow at an annual rate of 1.8 percent for a total of approximately CDN$21 billion. In addition, the Canadian government is investing in innovations such as precision medicine, artificial intelligence, and data and analytics, to improve care, improve health and reduce spending.

 

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 2017. Diagnostic apparatus, orthopedic, prosthetic, patient monitoring and dental equipment are Canada’s top five largest import categories. In 2016, the value of U.S. exports to Canada in these categories were valued at CDN$2.3 billion and Canadian exports to the U.S. were valued at CDN$70 million. The United States is the biggest exporter of medical devices to Canada, with the top five clusters for medical devices in the United States located in Minnesota, Florida, Pennsylvania, New York and California.

 

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.

Pricing & Reimbursement

Pricing and reimbursement decisions in Canada are highly decentralized. Per the International Society for Pharmacoeconomic and Outcomes Research (Ispor), most decisions are made by hospitals, which typically receive global funding for their services. Budgets are allocated to hospitals via geographic or operational health regions or authority in most provinces, and are bound by provincial law.

Regional or national consensus among physicians through professional networks can have a strong influence on decisions to reimburse medical technology.

The Canadian Medical Association maintains a database of around 1,200 Canadian clinical practice guidelines. Further information can be accessed at http://www.cma.ca/cpgs

 

Barriers

 

Health Canada as part of its engagement with the International Medical Devices Regulators Forum is working to align its information requirements for quality management systems with other regulators participating in the forum, in anticipation of one unified set of requirements recognized by Health Canada in late 2017.

Shortcomings in intellectual property protection, particularly a “heightened” utility standard for pharmaceutical products that has led to dozens of patent revocations, is causing operational difficulties for U.S. companies. New regulatory proposals to lower ceiling prices for patented medicines, such as reshuffling the basket of countries that Canada uses for price referencing, using pharmacoeconomic evaluations, and forcing companies to disclose confidential pricing agreements could dramatically shift the market access landscape in Canada.

Procurement & Tenders

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 procurement processes depend on the individual province, but are generally conducted by each hospital and depend on the need and resources available to the hospital.

U.S. suppliers looking to export to Canada should refer to the following websites for more information concerning procurement opportunities available in each province:

Provincial Procurement Authorities

Quebec

www.seao.ca

  • the Electronic Tendering System approved by the government of Quebec. It provides access to government contracting opportunities from public and municipal agencies in health networks.

Ontario

www.ontario.ca/tenders

  • the online system that hosts procurement opportunities and award notices for Ontario government procurements

British Colombia

www.bcbid.gov.bc.ca

  • the most convenient way to access the BC public sector tender opportunities.

Alberta

www.purchasingconnection.ca

  • the online tool that lets public and private sector users explore tender opportunities for goods and services in Alberta.

Manitoba

www.merx.com

  • includes all Manitoba goods and services tenders.

New Brunswick

https://nbon-rpanb.gnb.ca/

  • the New Brunswick Opportunities Network that posts tender notices for the province.

Nova Scotia

www.novascotia.ca/tenders

  • the provincial website offering comprehensive tendering opportunities.

Newfoundland and Labrador

http://www.gpa.gov.nl.ca/tenders/index.html

  • advertises tender bidding opportunities on their website.

Prince Edward Island

http://www.gov.pe.ca/tenders/tenders_all.php3

  • the provincial site that provides suppliers with information about all procurement opportunities available in PEI.

Nunavut

www.nunavuttenders.ca

  • provides all procurement opportunities available in the province.

Northwest Territories

www.contractregistry.nt.ca

  • advertises all contract event opportunities available in the province.

Saskatchewan

www.sasktenders.ca

  • lists all procurement opportunities available in the province.

Yukon

http://www.hpw.gov.yk.ca/csb/tender-management-system-tms.html

  • lists all procurement opportunities available in the province.

Government Links

Health Canada (https://www.canada.ca/en/health-canada.html)

Federal Healthcare Procurement

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

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/

Alberta: Alberta Health

http://www.health.alberta.ca/

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/

Trade Events

Health Achieve

November 6-7, 2017 Location: Toronto, Ontario

The largest healthcare 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/

Pharmed Manufacturing & Outsourcing 2017

November 15, 2017 Location: Mississauga, Ontario

The only Canadian conference dedicated to manufacturing and outsourcing for the pharmaceutical and healthcare industries

For more information, visit: https://www.pharmedoutsourcing.ca/

e-Health 2018

May 27-30, 2018 Location: Vancouver, Canada

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.

For more information, visit: http://www.e-healthconference.com

FAQs

Q: What are the distribution channels in Canada for medical devices?

A:Once the product is approved by Health Canada, distributors and Group Purchasing Organizations (GPOs) are the recommended distribution channels for the Canadian market.

Q: Do I need to hire a consultant to expedite the registration process with Health Canada?

A: No, the registration process highlighted on the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information.html) is self-explanatory and easy to follow. However, if there are complications, U.S. companies may wish to hire a consultant.

Q: Does my documentation need to be in English and in French for the Canadian market?

A: Yes, Canada is a bilingual country. So, the labeling and packaging information must be in both official languages with special attention given to the Province of Quebec (https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html#a24

 

Best prospects

Canada's top five largest import categories:

  • Diagnostic apparatus
  • Orthopedic
  • Prosthetic
  • Patient monitoring
  • Dental equipment

Industry sources indicate that in 2017 the Canadian medical device market will be valued at approximately USD$3.6 billion. Average growth rate is expected to be between 1.5-2 percent in the coming year.

Statistics Snapshot

Market Size

Healthcare spending:

USD162.5bn

... as percent of GDP:

10.6%

... of which spent on inpatient services (including long-term care):

30%

... of which spent on pharmaceuticals/consumables:

16%

Hospitals, Procedures, Healthcare Professionals

Number of hospitals:

1,154

…Public:

1,119

…Private:

34

Number of hospital beds:

138,043

... available beds per capita:

0.0038

Number of surgical procedures (inpatient-000s):

904.6

Physicians:

83,159

...of which surgeons:

10,069

...of which internists:

9,725

...of which pediatricians:

2,584

Dentists:

22,737

Demographics

Population:

35,151,728

Life expectancy men/women:

80.7/84.7

Infant mortality (per 1,000 live births):

4.3

Percent of population older than 65:

16.5

...projection, 2030:

23.6

Annual deaths (000s):

261.6

...caused by cancer (000s):

80.8

...caused by heart disease (000s):

51.5

Prevalence of chronic diseases (cancer, cardiovascular diseases, diabetes and hypertension):

14% increase each year

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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