The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003. CMDR do not require importers or distributors of medical devices to have a registered quality system.
Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer’s declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny. A guidance document for device classification is published by Health Canada.
Canadian classes of medical devices normally correspond to the European Council Directive 93/42/EEC (MDD) devices, there may be exceptions:
- Class IV (Canada) generally corresponds to Class III (ECD)
- Class III (Canada) generally corresponds to Class IIb (ECD)
- Class II (Canada) generally corresponds to Class IIa (ECD)
- Class I (Canada) generally corresponds to Class I (ECD)