In Canada, manufacturers of medical devices of classes II, III and IV according to the Canadian Medical Devices Regulations must hold licenses.
Implement the Canadian regulations
You can apply to the Canadian authorities for such a license only if you hold a certificate of conformity to ISO 13485 recognized in accordance with the Canadian Medical Devices Conformity Assessment System (CMDCAS).
DQS MED is one of the few certification bodies worldwide authorized to issue certificates of conformity to ISO 13485 in accordance with the requirements of the CMDCAS.
Since October 2003, DQS MED is accredited and listed by the Canadian accreditation authority Health Canada as a CMDCAS recognized registrar.
Use of CMDCAS Certification
Manufacturers also benefit from such certification according to ISO 13485 to demonstrate their competitive strength and efficiency in the national and international markets and to enhance their public reputation. A CMDCAS certified manufacturer:
- is able to effectively implement the Canadian regulations concerning medical devices,
- ensures that the products, components and services purchased from suppliers have the required quality,
- minimizes and controls risks,
- emphasizes the competence of the enterprise,
- prevents errors instead of correcting them,
- improves the quality of performance,
- provides transparency and clarity of internal processes, and
- saves time and costs.