UL provides 3rd party regulatory assessments as a CMDCAS recognized registrar
CMDCAS regulatory drivers – Health Canada
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 the recognized edition of ISO 13485 with the implementation of requirements from the Canadian Medical Device Regulations (CMDR), and upon successful completion, 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 CMDR (SOR 98/282).
Why Choose UL as your CMDCAS registrar?
- UL has been a CMDCAS recognized registrar since the program first went into effect in 2003 and our experienced and dedicated full time auditing team works closely with our customers to collaborate for compliance.
- A culture of Partner versus Provider – UL’s technical team will work with you to meet deadlines and internal needs. We engage with our customers regularly to work through the standard requirements and demonstrate compliance.
- Integrated assessments – UL experienced audit staff are typically qualified in multiple regulatory schemes and can reduce your overall audit burden by combining multiple audits into one, including UL NRTL Follow up, ISO 13485, Notified Body for EU, Japan PAL and Brazil INMETRO.
- Easy transfers – UL will recognize your existing accredited registration and pick up where your previous registrar left off. An experienced technical expert will provide direct guidance throughout the transfer process so your company can continue to sell in critical markets.
- Full Time staff – UL auditors are full time employees, delivering consistent service and limiting the amount of retraining required to become familiar with your systems and locations. You also have direct access to our technical team to help you respond to challenging situations.
- Trust and Confidence – Our team helps your business comply by applying the requirements properly
- Single partner for Canada – UL has the breadth of services to provide both your testing and certification for Canada regulatory requirements including Software, EMC, Safety, Usability, Home Health, Risk management and more.
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.
Training and Qualification
Training and qualifications are key factors to a successful quality system and one that regulatory agencies and auditors look for. Documentation of training and qualifications is necessary to demonstrate compliance to the quality management systems standards and regulations, and to help with resource planning and employee development. Through our award winning regulatory learning management system, ComplianceWire®, UL offers manufacturers of regulated products and quality systems a convenient, cloud-based qualification and learning system that is accessible to employees and quality staff around the world in 42 languages. With over 700 expert authored courses, UL has content that can meet your team’s needs. Learn More.
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Contact UL Health Sciences Team for a CMDCAS under ISO 13485 quote:
Toll free in North America: 1.888.503.5537
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.