Is European certification equal to ISO 13485 ?

We want to bring a new medical device class II to Canada from Europe. The device has CE certification by Directive 93/42/EEC. Is the European certification is equal to ISO 13485 standard or we need to apply for Canadian certification.

Answer:

The CE certification means that the Quality Management System (QMS) in place is compliance to ISO 13485 standard. As you are aware, each country has its own regulations, therefore, you still have to register for Canadian certification in order to market the device. But the QMS prepared earlier for CE certification could be useful for applying for Canadian certification.