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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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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:
- EU MDR Article 13 - General obligations of importers https://advisera.com/13485academy/mdr/general-obligations-of-importers/
- EU MDR Article 14 - General obligation of distributors https://advisera.com/13485academy/mdr/general-obligations-of-distributors/
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Feb 02, 2023
Feb 02, 2023
Feb 02, 2023