Importing Sample Medical Devices into South Korea

A

Ana Fuduric

#1
Dear all,

Can anybody help me please?

What are necessary accompanating documents to import samples of medical devices (non-sterile and sterile gauze product risk class I and I sterile) to South Korea?

Beside quality certificate, is declaration of conformity -93/42/EEC acceptable for South Korea?

Btw, beside quality certificate for samples of hygienic products ( cotton wool product) also maybe some necessary documents to import?

Thank you in advance,

Ana
 
Elsmar Forum Sponsor
#3
Dear all,

Can anybody help me please?

What are necessary accompanating documents to import samples of medical devices (non-sterile and sterile gauze product risk class I and I sterile) to South Korea?

Beside quality certificate, is declaration of conformity -93/42/EEC acceptable for South Korea?

Btw, beside quality certificate for samples of hygienic products ( cotton wool product) also maybe some necessary documents to import?

Thank you in advance,

Ana
My advise is to contact the Korea FDA directly. Refer KFDA Website
 
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