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Is European certification equal to ISO 13485 ?

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Guest user Created:   Feb 21, 2019 Last commented:   Feb 21, 2019

Is European certification equal to ISO 13485 ?

I have a question about ISO standard adaptation for the European company.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Verlene Law Feb 21, 2019
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.
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Feb 21, 2019

Feb 21, 2019