Does the KFDA need our distributor to have a copy of our Quality System ?

NhuTuyet

Starting to get Involved
#1
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.:nope:

Are they right to ask so many documents ? Why is a conformity declaration insufficient ? :confused:

Does anybody have a copy of the document that can confirm or not this statement ?

Many thanks & have a nice day.

NhuTuyet.
 
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sreenu927

Quite Involved in Discussions
#2
It is not required to send a copy of DHR with every shipment.
Only during the registration, they wud like to have the QC inspection and/or outgoing checklist for the product. This is one of the documents that they require during registration.

Regards,
Sreenu
 

NhuTuyet

Starting to get Involved
#3
Hi Sreenu !

Thanks for your answer !!

How can I tell our local distributor that is not required to send a copy of each DHR with every shipment ? Do you have a document reference ?

It is true that I have sent the DHR for the shipment that has been inspected by the GIP.

Have a nice day.

NhuTuyet.
 

sreenu927

Quite Involved in Discussions
#4
Hi NhuTyuet,

There is no KFDA regulation stating to ship a copy of DHR document with every shipment.

You ask your distributor whereabouts of such regulation mentioned?

No KFDA won't check each and every shipment for DHR and even if you send DHR, it is not essential for them to check.

Regards,
Sreenu
 

NhuTuyet

Starting to get Involved
#5
Hello !

I am starting to get very confused and annoyed. My local distributor in South Korea is now asking me the document reference from the KFDA that stipulates that I don't have to send him the DHR for every medical device that has been shipped to him.

Do you have any advice for me please ?

I think that I have my back to the wall :frust:. Please help me!!!!

Thanks & have a nice day !
 

sreenu927

Quite Involved in Discussions
#6
You ask the same question to him..to show you the regulation by KFDA that DHR records are essential with every shipment!
DHR is a set of batch records, it is not practical to send that big file of records with every shipment. If he still insists, u can make DHR index (one page) and just like a packing list, ship this along with the instrument. But, no requirement of sending DHR with each and every shipment!

Regards,
Sreenu
 

NhuTuyet

Starting to get Involved
#7
Hello everyone !

It's me again !! With the same problem ...

So my Korean contact sent me an extract from the "Enforcement rules of medical scheme " (Order of the Ministry of Welfare and Health #28, December 13th, 2010).

According to him, it is the regulation that stipulates that we have to send DHR files with every shipment.

But there may be a misunderstanding : I read the extract's translation he gave me and what I understand is that the import compagny must have a "product standard " (this is the translated term used by my contact) per item (but not with every shipment. Moreover I think that the "import management standards" is an equivalent for our process (testing, non conformity management, ...). I don't see the obligation for me to send the DHR files with every shipment.

What is your opinion regarding this regulation ?

Thank you for your help.

Have a nice day.

NhuTuyet.
 

Attachments

sreenu927

Quite Involved in Discussions
#8
In my view, "product standard doc" could be a Certificate of Conformance (C of C), which can be sent with every shipment, rather than DHR!

Thanks for the attachment.

Regards,
Sreenu
 
M

Michelleyoungjuoh

#9
Does anyone know the approximate break down of time it takes to register Class I and II medical devices in Korea? This would include the time it takes to find a local distributor, to the time that a product license/importer license is issued?

Thanks!!
 
E

Erik Nielsen

#10
In my view, "product standard doc" could be a Certificate of Conformance (C of C), which can be sent with every shipment, rather than DHR!

Thanks for the attachment.

Regards,
Sreenu
Hi,

For what its worth, we have had the same request from our distributor i.e. to send the same documentation with each device as we did with the one used for the registration process. We never did that but we do send safety test results and calibration data for each device and it seems to work.

Regards,

Erik
 
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