Regulating the sale of medical devices in Canada follows the principles very similar to the European ones.
It is essentially based on review and certification of the manufacturer's Quality System followed by a registration for the licensing of exports to Canada.
The quality system is based on standard CAN / CSA ISO 13485, similar to EN ISO 13485, with the addition of special requirements (CMDCAS). The verification must be made by an organization recognized by the Ministry of Health Canada (Registrar).
After the verification and release of CMDCAS certificate, the manufacturer must record the factory details (MDEL) together with the product to be exported (MDAL).
ISEMED offers the following services:
- Gap analysis according to the standard CMDCAS
- Adjustment to the Quality System according to the standard CMDCAS
- Assistance in the inspection activities of the Registrar in the company
- Preparation of documentation for MDEL and MDAL recording MDEL and MDAL management practices