What are CMDR and CMDCAS and why do I need an ISO 13485 quality system?
The Canadian Medical Device Regulations (CMDR), which took effect on January 1 2003, are the standards that must be followed in order for manufacturers to sell medical devices in Canada. For manufacturers of Class II, III, and IV medical devices, an ISO 13485 quality system is required. These devices must be audited every year by a recognized Certification Body under CMDCAS.
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)
There are no regulatory quality system requirements for Class I medical devices. CMDR also do not require importers or distributors of medical devices to have a registered quality system.
CMDCAS was developed by Health Canada and the Standards Council of Canada (SCC) to implement these new regulations. SCC accredits organizations that certify the management systems of medical device manufacturers. Under CMDCAS, only certification bodies accredited by SCC such as BSI are eligible to certify a medical device manufacturer’s management system to ISO 13485.
Following the Medical Device Single Audit Program (MDSAP) pilot, Health Canada have announced that MDSAP will replace the CMDCAS system, effective January 2019. Any manufacturer wishing to sell devices into Canada will need to be certified under MDSAP.