What are CMDR 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.
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.
The Canadian Medical Device Conformity Assessment Scheme (CMDCAS) under which the past ISO 13485 certificates were issued has been replaced by the Medical Device Single Audit Program (MDSAP) . 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)
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.
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.