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ISO 13485:2016 regulatory expectations around distributors

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Guest user Created:   Apr 26, 2021 Last commented:   Apr 28, 2021

ISO 13485:2016 regulatory expectations around distributors

What are the ISO 13485:2016 regulatory expectations around distributors?

Around distributor qualification, management, customer complaints, supply or QA agreements,

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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.

Expert
Kristina Zvonar Brkić Apr 28, 2021

ISO 13485:2016 is applicable to the distributors as well, according to section 1 of the standard. So it is expected that distributors will have implemented the ISO 13485:2016. Their quality management system will cover their distribution scope: how they receive medical devices, which documents they must check when receiving it from the manufacturer, how to store it, how to deliver it to the customer/client. Distributors must have in place a customer complaint process, have a proper place where returned products will be placed, and must have in place the process of communicating with the competent authority when needed.

Distributors must have in place QA agreements with manufacturers where mutual responsibilities will be stated.

For more information on the distributor's obligations, please see:

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Apr 26, 2021

Apr 28, 2021