Canadian Medical Device Conformity Assessment System (CMDCAS)
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 such as UL 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. UL, as a CMDCAS recognized registrar is able to provide the necessary certification of your quality management system as required by section 32 of the Canadian Medical Devices Regulations (SOR 98/282).
The UL advantage
UL has been a CMDCAS recognized registrar since the program first went into effect in 2003. UL offers local contacts, market experience and dedicated expert auditors.
UL's ISO 13485:2003 quality management systems registrations for Canada complements our suite of end-to-end market access services for medical device manufacturers. Manufacturers of electromedical devices must have certification to the appropriate Canadian safety 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 can combine 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.
UL can audit both your quality management system and risk management system during the same visit, saving you time in hosting multiple audits.
UL is an accredited registrar under ISO 13485 with auditors located around the world, in your time zone who can speak your manufacturer's local language. And with UL, you can schedule integrated audits of your management system to take advantage of the similar requirements synergy among your various quality management system needs.
Impartiality statement
UL 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 industry 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)
