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.
Canada and the Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities (RAs).
Health Canada is a participating RA, having completed the three year pilot phase of the Program, which ended in December 2016. In December 2015, Health Canada announced that it will use only MDSAP audits, replacing CMDCAS as the mechanism to achieve regulatory compliance for quality management system requirements in Canada. Manufacturers must have transitioned to MDSAP by January 2019.
MDSAP audits are conducted by recognized Auditing Organizations (AOs); BSI is a recognized AO and participated in the Program's pilot phase.
Find out more about the Program, who is involved and BSI's role now.
What is BSI's role in market access in Canada?
As an accredited registrar under CMDCAS, we audit medical device companies worldwide to ensure proper registration, quality system compliance and distribution. Navigating the regulatory processes for medical devices can be a challenge, and we can support you as you understand the regulations and get compliant, allowing you to make an impact in the marketplace.
BSI is also a recognized Auditing Organization (AO), so can continue to support your market access requirements throughout the transition to MDSAP and beyond.