Guest user Created: Oct 31, 2018 Last commented: Oct 31, 2018

Submission of Non-conformity Report

I work at a company here in Brasil.We are ISO 13485 certified and I would like to know where do we have to send the nonconformities report. It is written that the Recipient must be the National Competent Authority (NCA).

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Verlene Law Oct 31, 2018

Wich one?

Answer:

National Competent Authority refers to a government body that is in charge of handling matters related to medical devices in your country. In this case, it should be ANVISA. You might want to discuss with the certification body that audited for ISO 13485 if necessary before any submission.

For more information, you might want to refer to :

ISO 13485:2016 nonconforming product – How to approach the post-delivery actions
https://advisera.com/13485academy/blog/2017/04/11/iso-134852016-nonconforming-product-how-to-approach-the-post-delivery-actions/

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Oct 31, 2018

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