Canada Medical Device Registration – Compliance with Canadian Medical Device Regulation
How to Get approval for Canada Medical Device Registration ?
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. The quality management system is evaluated under the Medical Device Single Audit Program (MDSAP).
The level of regulatory scrutiny to be applied is based on risk management principles that use a rule-based system to classify medical devices into four classes, with Class I representing the lowest risk and Class IV the highest. Here are some examples of devices relating to product classification
- Class I: Adhesive strip, endoscopic still camera, fiberoptic illuminator for an endoscope, intraoral dental light, manual, adjustable, hospital bed, oropharyngeal airway (anaesthesiology), surgical microscope system, surgical or dental instruments, tympanoscope…
- Class II: Daily wear, soft contact lenses, disposable surgical instruments, hysteroscopic insufflator, laryngoscope, latex condoms, orthodontic brackets, piston syringe, short term, intravascular catheters, steam sterilizer…
- Class III: Amalgam alloy, angiographic system X-ray, electroanesthesia apparatus, high energy DC defibrillator, infusion pump, intrauterine contraceptive device, peritoneal, long term indwelling catheters, tracheal stent, volume ventilator (critical care)…
- Class IV: Aneurysm clips, angioplastic coronary laser, breast implants, cerebral blood flow monitor, external pacemaker pulse generator, fetal blood sampling endoscope and accessories, fetal ph monitors, tissue heart valve…
To sell a medical device in Canada, manufacturers must meet the regulatory requirements as defined in the Medical Devices Regulations.
Class I medical devices offered for sale in Canada do not require a medical device licence and are monitored through Establishment Licensing.
Class II, III, and IV medical devices offered for sale in Canada require a medical device license. To successfully apply for a medical device license the manufacturer must submit supporting documentation to demonstrate its safety and effectiveness.
Regulations also require that the 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. These manufacturers must have their QMS registered by a Registrar accredited to the MDSAP scope. For more information about the MDSAP program please refer to our page here.
You can find more information on this page http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php