Medical Devices-In Vitro Diagnostic Devices-Biotechnology-Pharmaceuticals

The Canadian Medical Devices Conformity Assessment System (CMDCAS) is modeled after the European Union regulatory structure with some important differences:

• The Canadian Medical Device Regulations are the principal regulatory requirements.
• Canada uses recognized Standards not European Harmonized Standards.
• Canada uses Safety and Effectiveness Requirements not European Essential Requirements.
• There is limited presumption of compliance even when using recognized Standards.
• SSC accreditation is normally required for testing laboratories.
• Canada issues Medical Device Licenses that permit sale in Canada.
• Establishments are required to register with the Government of Canada.
• The Quality Management System is based on the Canadian National Standard CAN/CSA/ISO 13485:2003.
• Your Quality System Registrar must be CMDCAS accredited.

There are several other important considerations including transitioning from ISO 9001, ISO 13485 or ISO 13488 quality management system standards; IDE requirements, post market surveillance, instructions for use, labeling and there are a host of new user fees. In short, Canada is an entirely separate jurisdiction that has unique requirements to satisfy prior to market access.

Horizon Phoenix offers valuable assistance in helping you implement effective regulatory processes and quality management systems using the requirements of:

• Canadian Medical Device Regulations
• National Standards of Canada
• Safety and Effectiveness Determinations
• Labeling, instructions for use and contraindications and warnings
• Minimizing user fees
• Obtaining appropriate Medical Device Licensing, and
• Establishment Registration

Ask Us How!...

Why Horizon Phoenix?

Our Senior Partner was Chairman of the Ad hoc Stakeholders committee assisting Health Canada develop the new regulations and moderated a series of North America-wide consultation seminars discussing the impact of the new regulations with more than 700 different stakeholders.