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)
For manufactures who wish to sell Class II, III, and IV medical devices, Health Canada requires you to provide an ISO 13485 quality system certificate as evidence of compliance to the Canadian Medical Device Regulations (CMDR). This certificate can only be issued by a Canadian Medical Devices Conformity Assessment Scheme (CMDCAS) recognised registrar such as BSI.
