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ISO 13485 for trading of medical devices

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Guest user Created:   Feb 02, 2023 Last commented:   Feb 02, 2023

ISO 13485 for trading of medical devices

Dears, I'm working currently in a company that export and import some medical devices (without manufacturing ), is it eligible to be certified with ISO 13485?

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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 Feb 02, 2023

If you only make export and import of medical devices, It is not a regulatory requirement to be ISO 13485 certified. What is expected from the importer and distributor of medical devices is stated in Article 13 and Article 14.

For more information, see:

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Feb 02, 2023

Feb 02, 2023