Medical devices have a vital role to play in the health and well-being of a country’s population. With this vigilance in mind, Health Canada implemented a series of regulations to improve the safety of medical devices sold in Canada and to bring Canada’s regulations in line with those of its major trading partners. By virtue of this, Health Canada reviews medical devices to assess their safety, effectiveness, and quality before being authorized for sale in the country.
Typically, a rule-based system to classify medical devices determines the level of regulatory scrutiny applied to the devices. This classification is divided into four classes, with Class I having the least risk and Class IV representing the highest risk.
While Class I devices make only non-invasive contact and do not transmit energy to the patient, Classes II, III and IV comprise of devices that have an increasingly higher risk. This is determined by factors such as the degree of invasiveness, the hazards of energy transmission, and the potential consequences to the patient in case of device malfunction or failure.
Some examples of devices relating to product classification include:
- Class I: Manual, adjustable hospital beds, surgical or dental instruments, fiberoptic illuminators for endoscopes
- Class II: Soft contact lenses, disposable surgical instruments, orthodontic brackets, intravascular catheters
- Class III: Angiographic system X-rays, high energy DC defibrillators, intrauterine contraceptive devices, tracheal stents
- Class IV: Aneurysm clips, breast implants, external pacemaker pulse generators, cerebral blood flow monitors
Manufacturers must meet the regulatory requirements prescribed by the Medical Devices Regulations to sell medical devices in Canada. According to these regulations, Class I devices do not require a medical device license and are monitored through Establishment Licensing. On the other hand, Class II, III, and IV medical devices require a medical device license prior to sale, import or advertisement of these devices.
In order to successfully apply for a medical device license, manufacturers need to submit supporting documentation to substantiate the safety and effectiveness of the device. Moreover, regulations require that manufacturers of Class II, III and IV devices design and manufacture their products under a registered quality management system (QMS) that meets the criteria of the international standard ISO 13485: 2016.
All VeriCheck products have the appropriate Health Canada licensing, and you should make sure that ALL of the drug testing products you use have the Health Canada license they require, otherwise, they should NOT be used in Canada.