Hello everyone !
We are manufacturing class I, IIa & IIb medical devices and selling them worldwide.
We have registered our products in South Korea and our local distributor has undergone the GIP inspection.
Now our local distributor wants us to send with every medical devices shipment a copy of all our DHR.
Are they right to ask so many documents ? Why is a conformity declaration insufficient ?
Does anybody have a copy of the document that can confirm or not this statement ?
Many thanks & have a nice day.
NhuTuyet.
We are manufacturing class I, IIa & IIb medical devices and selling them worldwide.
We have registered our products in South Korea and our local distributor has undergone the GIP inspection.
Now our local distributor wants us to send with every medical devices shipment a copy of all our DHR.

Are they right to ask so many documents ? Why is a conformity declaration insufficient ?
Does anybody have a copy of the document that can confirm or not this statement ?
Many thanks & have a nice day.
NhuTuyet.
. Please help me!!!!