ISO 13485 certification
I work for *** in the UK. I am trying to find out if I can import 4 ply face masks from a supplier in Vietnam that has the ISO13485:2016 certificate. I don't know if this is adequate or if the masks need to comply with EN or EU regulations.
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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
These masks are class I medical devices, so they do not need a certified CE mark. It is enough that manufacturers have ISO 13485:2016 and masks must be done in accordance with ISO 14683:2014 Medical face masks — Requirements and test methods. Proof that these masks are prepared according to this standard must be written on the packaging and in Declaration of conformity which must provide the manufacturer.
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May 03, 2020