CMDCAS Canadian Medical Device Conformity
Canadian Medical Device Regulations require manufacturers selling class II, III and IV medical devices within Canada to be registered to ISO 13485:2003 by a quality system registrar accredited by the Standards Council of Canada (SCC) and recognized by Health Canada under the CMDCAS program...
Since January 1, 2003, Canadian Medical Device Regulations require manufacturers selling class II, III and IV medical devices within Canada to be registered to ISO 13485:2003 by a quality system registrar accredited by the Standards Council of Canada (SCC) and recognized by Health Canada under the CMDCAS program. LRQA is recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) in accordance with the requirements of Q90R0 Policy on CMDCAS.
For Class II, III or IV medical devices to be licensed by Health Canada, their manufacturers' quality management systems are required to be registered to at least ISO 13485:2003 by a CMDCAS recognized registrar.
Certification to the quality management system standards like ISO 13485 help create a systematic framework in which organisations drive continual improvement, providing a competitive advantage for your organisation because it:
enables you to work with many organizations where it is a contractual obligation or expectation
can provide improved performance measurable in key metric areas such as increased efficiencies, reduced costs and increased revenues
eases the entry of products and services into foreign and domestic markets and reduces technical barriers to trade since many international trade agreements support the use of international standards and the mutual recognition of conformity assessment results
exposes businesses to the expertise and research of other organizations within the same industry or sector, translating into enhanced designs and new ideas
provides businesses with tools to manage risk through the safety and efficiency of their own practices and products
allows demonstration of social and environmental responsibility in business practices, positively impacting public perception and consumer confidence
For further detail about CMDCAS, visit the Standards Council of Canada.
Why choose LRQA?
LRQA respected, world renowned registrar accredited by the Standards Council of Canada (SCC) and recognized by Health Canada to deliver accredited CDMCAS certification.
LRQA is a market leader in the provision of assessment, certification and training services, and over half of the world's top 200 companies choose LRQA.
Our medical assessors are industry specialists and experts who are matched with your business needs, enabling an effective and robust assessment of your system.
Our Business Assurance approach ensures our assessments focus on the areas and issues that are important to your business. As the first certification body to gain accreditation for issuing quality management system certificates, we understand system requirements and can therefore tailor our approach to help meet your objectives.
Beyond certification, LRQA provides an extensive range of services to support your business’ future growth and development, including training solutions and integrated management systems assessment.
To find out how we can help your business please contact your nearest office or complete our enquiry form: