In today’s marketplace for Medical Devices it is also highly desirable to design a new product with access to major international markets, in addition to Europe. DNV GL work with a number of partners globally to offer a combined assessment and project management of securing local approvals, saving manufacturers valuable time as they navigate the complex global compliance landscape.
Medical Devices Regulations (SOR/98-282) – Government of Canada
Canadian Medical Devices Conformity Assessment System (CMDCAS) Quality System Requirements – Health Canada
In order to place a Medical Device or an In Vitro Diagnostic Device on the market in Canada, manufacturers must meet the requirements of the Medical Devices Regulations. The Therapeutic Products Directorate (TPD) is the regulatory agency that is responsible for ensuring that the medical devices are safe, effective and of high quality. Manufacturers of Class II, III and IV devices must also obtain a licence.
Within the framework of the Medical Devices Regulations, manufacturers are also required to demonstrate an appropriate Quality System according to CAN/CSA-ISO 13485:03 (Class II, III and IV.) In order to verify the quality system, manufacturers must have their quality system assessed and registered with a competent third-party Registrar who is accredited under the CMDCAS scheme.
Basic Technical Concepts
CMDCAS follows the basic general requirements of the international standards ISO 13485 and supplements these with specific national requirements required to meet the Canadian TPD’s oversight responsibilities.
In addition to delivering accredited certification of ISO 13485 quality systems, DNV GL can also offer its clients and evaluation against the CMDCAS requirements and project manage the registration of the quality system.
ISO 13485 – Medical devices -- Quality management systems -- Requirements for regulatory purposes