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Can someone share their experience with KFDA Inspection ?

P

phloQS

#1
Hi all,

Does anybody have any experience with an inspection mae by KFDA? We are an european producer of serveral endoprothesis (DIN EN ISO 13485, Annex II MDD and others)and have a local distributor in Korea. Our distributor contacted us and told us that KFDA wants to perfom an inspection in our site in Germany, insteda of just a KIP at the distributors office. Is that normal? What do we have to expect? They want to do the inspection for a whole week! Is our quality system sufficient for the inspection, or are there any further requirements by KFD (in comparison with ISO 13485)
Any help appreciated!

Kindest Regards

phloQS
 
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sreenu927

Quite Involved in Discussions
#2
Re: KFDA Inspection

Hi,

Inspection to foreign manufacturers is the new regulation implemented by KFDA since 8 April 2012.

The priority is Class III and IV devices with immediate effect followed by Class II in 2013 and Class I from 2014.

It is based on ISO 13485 and KFDA medical device regulations guidance document.

All the best!

Regards,
Sreenu
 
P

phloQS

#3
Re: KFDA Inspection

Hi sreenu927,
Could you provide me with a link or a copy of the document "KFDA medical device regulations guidance document". Is it totally similar to EN ISO 13485? Do myou have a guidance which compares the chapters?

Regards

phloQS
 
R

REG_personnelSG

#5
Hi phloqs,
According to our consultant/distributor in Korea, if KFDA ever decides to perform an audit inspection at the manufacturing site, the cost of the audit (travelling cost of the officers etc) would be entirely incurred by the manufacturer! Is that true for your case?

Thanks!
 
P

Ponzelle Royster

#6
We are a US manufacturer that sells our device to a South Korean Distributor and we have been requested by that distributor to send proprietary documents, such as equipment and validation, production suite layout, names of positions, DMR, etc. to them to host the GMP inspection that is scheduled for 07/2013 based on their new KFDA regulations in 2012. They want them now to translate into Korean. The new regs recognizes the distributor as the Korean License Holder and the Importer. The Importer can sell to other distributors within S. Korea.

I have requested the inspection to be performed on site in US; the Korean distributor indicates that the cost would be 200000 USD at their cost.

Has anyone got any updated information regarding these inspections or have any comments?
 

sreenu927

Quite Involved in Discussions
#7
Hi Royster,

Welcome to Cove:)

Thanks for posting such an informative post.

By the way, what class of products are you supplying into Korea, what is the US Classification?

Is the cost, USD 200 000 borne by KFDA/Distributor?

Regards,
Sreenu
 
P

Ponzelle Royster

#8
The cost of the KFDA inspection of manufacturers is incurred by the distributor that is now considered the Korean License Holder (KLH) and the Importer. We are in the process of trying to find out if there is a more realistic cost as our distributor has given that estimate. Due to their estimate of cost, they would prefer to keep the inspection at their location and supply the excessive amount of documentation.

I need feedback from anyone who has experienced an inspection by KFDA and has some idea of the cost to perform an on-site inspection of the exporting manufacturer.
 
P

Ponzelle Royster

#9
Classification of the device is Class II in the US and the same in Korea although KFDA has four categories - I, II, III & IV.
 

sreenu927

Quite Involved in Discussions
#10
I think I have slightly different information.
W.e.f 8 April 2012 KFDA has implemented IVD regulations and changes in Medical Device Regulations, which also include Foreign Manufacturer Inspection.

The importers are required to under go KFDA inspection (not exactly the KFDA inspects, but some related agency) to obtain KGIP Certificate.

With the new regulations, the agency is not going to issue KGIP, instead issue KGMP cert even to importers, although no manufacturing is involved.
If this KGMP inspection is done, before 8 April, then the concerned foreign manufacturers are exempted or in a way may not be in the list of KFDA Inspection until 2014.

Else, with regards to the classification of the medical device, KFDA plans to inspect the foreign establishments (Class II- 2014, Class III- 2013, Class IV-2012).

Any comments?

Thanks,
Sreenu
 
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