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Deviceology - The Canada Market Access People

Deviceology excels in guiding clients through the intricate landscape of Canada's Medical Devices sector. With a strong foundation in international regulations and ISO standards, including ISO 13485 for quality management systems, we provide an all-encompassing range of services to ease your entry into the market.

Our specialists offer crucial advice on meeting the rigorous regulatory standards enforced by Health Canada. Additionally, we provide an in-depth understanding of the Medical Device Single Audit Program (MDSAP), which allows manufacturers from MDSAP-participating countries like the U.S. and EU to streamline their approval processes in Canada.

Furthermore, Deviceology has a keen grasp of consumer needs and market trends within Canada. Our market analysis services pinpoint untapped opportunities and growing sectors—such as cardiology and orthopedic devices, which are in rising demand due to Canada's ageing demographic.

Our holistic solutions, spanning from initial market analysis to product launch, are crafted to comply with both international and local standards. This encompasses adherence to the Canadian Medical Devices Regulations (SOR/98-282) and a nuanced understanding of Canada's healthcare funding and policies, including both its public and private healthcare systems.

By collaborating with Deviceology, clients can expect a seamless, compliant, and well-strategised entry into Canada's lucrative Medical Devices sector.

 

Market Data

Medical Devices Market Valuation

Market Segmentation

  • Cardiovascular and Respiratory Devices: 22.3% of the market

  • Surgical Devices: 19.4%

  • Medical and Industrial Diagnostic Devices: 18.1%

  • Spinal Devices: 11.7%

  • Diabetes Monitoring Devices: 6.3%

Healthcare Expenditure

Hospitals alone account for an estimated 26.4% of total healthcare spending in Canada. The healthcare system is a mix of public and private sectors, with procurement mandated differently by each province.

Opportunities

  • Aging Population: Canada has an aging population, providing an opportunity to focus on medical devices to aid older population groups.

  • Technological Advances: Advances in data analytics and AI are driving predictive, preventative, and personalized medicine.

  • Virtual Care: The telehealth market is growing at 35% per year, offering opportunities for medical devices that incorporate virtual care.

2023: projected to reach $9.93 billion

2028: projected to reach $12.88 billion

Annual growth rate of  5.34%,

Market Dynamics

The industry is experiencing increased demand due to the rise of chronic diseases and an aging population.

 

Regulatory oversight is provided by Health Canada’s Medical Device Bureau, and devices are categorized into four classes under Canada’s Food and Drugs Act and Medical Device Regulations.

Manufacturers for class II, III, and IV devices need to hold a Canadian Medical Device License (MDL) and be certified through the Medical Device Single Audit Program (MDSAP).

Contact us to discuss your access requirements for the Canadian Medical Devices market

Deviceology - The Market Access People

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