Published in 1998 as part of the Food and Drugs Act, the goal of the CMDR is to ensure that medical devices that are sold or imported in Canada are safe and effective for their intended use. The regulations apply to the sale or advertisement for sale of any medical device, as well as the import of any medical device for sale or for use on other individuals. The CMDR does not cover the import of medical devices for personal use.
Under the CMDR, medical devices are classified into four different categories that correlate to their assessed risk. An accurate understanding of the classification system and appropriate classification of your company's device is key to streamlining your regulatory pathway. .
The CMDR provides a list of 16 rules that can be used to classify medical devices, but it is the duty of manufacturers to classify their devices correctly based on the characteristics and intended use of their device, regardless of whether the rules indicate that a similar device would be classified a particular way. Each rule includes exceptions that could result in a medical device being classified differently.
For example, Rule 1 states that all surgically invasive devices should be designated as Class II devices, however those intended to be absorbed by the body should receive Class III risk designation. Rule 10 states that active diagnostic devices should be given Class II designation, however, if an incorrect reading could lead to immediate danger for the patient, the device should receive Class III designation.
Under the CMDR, Class I medical devices are seen as the lowest risk and do not require a medical device license to be sold in Canada. Still, the office of the Minister of Health may suspend the sale of a particular device if it requires more information to determine whether the device meets appropriate requirements for sale under sections 10 to 20 of the CMDR.
Medical devices that are in risk Classes II, III and IV require a medical device license to be sold legally in Canada. Medical device license applications must include the name and classification of the device, along with the identifier of the device, the name and address of the manufacturer as appears on the label and the address where the device is manufactured.
Devices that are classified as having higher risk require increasing levels of documentation before a license can be obtained, including a quality management system certificate for all devices rated as Class II or higher.
While the United States FDA conducts its own quality inspections, Canada requires that medical device companies obtain a quality management certificate from a notified body indicating that the QMS used to manufacture the device satisfies the National Standard of Canada CAN/CSA-ISO 13485.
Greenlight Guru's Quality Management Software Platform was designed specifically to meet the compliance needs of medical device companies as an out-of-the-box solution, ensuring the quickest route to ISO 13485 compliance and the shortest time to market for our partners in medical device manufacturing.
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