Canadian Medical Device Conformity Assessment System
Manufacturers of Class II, III, and IV medical devices selling their products in Canada must submit their devices for licensing by Health Canada. Health Canada reviews the product for safety, effectiveness, and quality, relying on its Canadian Medical Device Conformity Assessment System (CMDCAS) recognized registrars, such as UL, to ensure that manufacturers have an adequate quality system. CMDCAS recognized registrars audit a medical device manufacturer's quality system to ISO 13485:2003 with the implementation of requirements from the CMDR, then provide a certificate of registration. Manufacturers then use this certificate as part of the submission for a device license with Health Canada. With qualification by the Standards Council of Canada (SCC), UL can provide the CMDR-required quality management system assessments that govern medical devices entering the Canadian market.
The UL advantage
As a CMDCAS recognized registrar since the program first went into effect in 2003, UL has the experience to help you understand the regulatory requirements to apply for license of your medical devices in Canada. UL offers local contacts, market experience and dedicated expert auditors. With UL's integrated service packages, you can even have the same expert who evaluates your product audit your quality system.
UL's ISO 13485:2003 quality management systems registrations for Canada complements its suite of end-to-end market access services for medical device manufacturers. Manufacturers of electromedical devices must have certification to the appropriate Canadian standard, by an accredited organization such as UL. Testing and certifying your products for the UL Mark and the cUL Mark for Canada provides unequalled mark recognition throughout North America.
For both electrical and non-electrical devices, UL provides integrated audits for multiple regulatory requirements. This integrated audit combines the requirements of Canada's CMDCAS program, Europe's Medical Device Directive and In Vitro Diagnostic Directive, Japan's Good Manufacturing Requirements, and Brazil's InMetro requirements.
In addition, UL is the first certification agency to offer Registration to ISO 14971:2001 -- the risk management standard referenced in both ISO 13485:2003 and IEC 60601 3rd edition.
Impartiality statement
Underwriters Laboratories places the utmost importance on the integrity and impartiality of its management system certification activities and the trust it conveys to its clients, their customers and the public at large. The principles inspiring this confidence include impartiality, competence, responsibility, openness, confidentiality, and responsiveness to complaints. These principles are identifiable in UL's Mission Statement. If any internal or external person or body should ever have concern of a situation that may threaten impartiality, it should immediately be brought to the attention of the UL Health Sciences General Manager.
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Additional resources
- Health Canada medical device license listing
- Health Canada website
- See if your risk management system meets ISO 14971 requirements: download the ISO 14971 checklist (registration required)
- Sign up for UL's medical e-mail list
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