Canadian License Applications
With close to 1,000 medical device manufacturing facilities, Canada is a strong and thriving market, producing a wide range of medical technology products representing a broad spectrum of specialties, including surgical and dental equipment, software, orthopedic devices, cardiovascular products, and in-vitro diagnostic kits. Canada is also an attractive market for firms wishing to import medical devices. In 2005, medical device imports were valued at over $2 billion. While more than half of those imports originated from the United States, Canada is experiencing impressive growth in imports from other areas of the world, including Europe, Asia, Latin America, and Australia.
Canadian Medical Device Regulations
Medical devices sold into the Canadian market must comply with Canadian medical device regulation. Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. The Canadian medical device regulations (CMDR) categorize medical devices based on risk as Class I, II, III, or IV. All but Class I devices require a medical device license application. While Class I devices do not require a license, manufacturers, distributors and importers are required to obtain an establishment license.
Aptiv Solutions has helped numerous clients understand and comply with Canadian medical device regulations. We will work closely with you to determine how your device is classified and prepare the necessary documentation to meet Canadian medical device regulations.