Can someone share their experience with KFDA Inspection ?

P

Ponzelle Royster

#21
This is only our experience with trying to obtain KGMP under the new MFDS regs: The Korean distributor collected all our information for KGMP and registration of additional Class II and III (Korean classification) and subsequently re-engineered our entire product line with another manufacturer. KGMP was never obtained for us but for the other manufacturer. The products, by the other manufacturer, are registered and in the Korean database. We are in the process of legally pursing patent infringement as the "other" company is in the US. We have also contacted the Korean Embassy in Seoul.

We also have identified another distributor but are using a Third Party based in the US with presence in South Korea to register our products and secure KGMP. This strategy will allow our control of the registration.

I wanted to share this information in order that others place caution on the type of information submitted for registration and/or KGMP. We are also notifying the MFDS.
 
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Q

QARAM

#22
My company just got notified from the distributor that the KFDA wanted a four-day audit. The audit agenda though came from someone called the KTL (Korea Testing Laboratory). Anyone heard of them?

Ponzelle, do you have any updates on your situation? This upcoming audit smells of the same situation and I'd like to avoid it.
 

Ajit Basrur

Staff member
Admin
#23
My company just got notified from the distributor that the KFDA wanted a four-day audit. The audit agenda though came from someone called the KTL (Korea Testing Laboratory). Anyone heard of them?

Ponzelle, do you have any updates on your situation? This upcoming audit smells of the same situation and I'd like to avoid it.
In Korea, there are 4 agencies registered by KFDA -

KTL(Korea Testing Laboratory) 
KTR(Korea Testing & Research Institute) 
KCL(Korea Conformity Laboratories) and 
KTC(Korea Testing Certification)

Korea Testing Laboratory (KTL) is the only accredited laboratory performing type testing for all 39 categories of medical devices available in the marketplace.

http://www.ktl.re.kr/eng/
 
Q

QuaProQuo

#24
My company just got notified from the distributor that the KFDA wanted a four-day audit. The audit agenda though came from someone called the KTL (Korea Testing Laboratory). Anyone heard of them?

Ponzelle, do you have any updates on your situation? This upcoming audit smells of the same situation and I'd like to avoid it.
FYI: I heard from the QA Director of a US-based anti-microbial biomaterials manufacturer that their KFDA audit was long and brutal, with white gloves and fine-toothed combs. This is an US-FDA-registered company with clearance of several class II devices.

She was very interested in my experience, since I worked up until recently for a Korean company. It was 180 degrees. We had senior, high-level MFDS(KFDA) officials make social calls before and after our 1-day audits, to assure us that we had their complete support for approval of our class II devices. We always had dinner and drinks with our auditors, after the fact. We were told not to worry; changes in the agency were not "meant" to disrupt national manufacturers.

In general, this is what the Korean agency feels that the US agency really does for its national manufacturers, so, why not?

Good luck with everything.
 
P

Ponzelle Royster

#25
Thanks for your information about the inspection, shouldn't inspections be done using the ISO13485 model for devices? My company could not get the former distributor to transfer the KLH or place our new distributor as a sub-distributor. We are starting the registration from scratch although our products are already in the Korean database but registered with the former distributor. I am working with a regulatory consultant in Seoul and I am not sure the person understands the new MFDS regs or if anyone does. We have submitted the packages for Class II and III products and awaiting response. Prior to submitting the package, I had to convince the consultant that we did not have to perform our biocompatibility testing again by the Korean Testing Lab as our materials have not changed since design and the labs were GLP (ISO17025). We now have to get KGMP and I am getting the same exhaustive list from the consultant for proprietary information. I will send only the items from the list I got from the KFDA (MFDS). I will keep everyone informed on useful information.
 
P

Ponzelle Royster

#26
We are in the process of re-registering our devices through another Korean distributor and getting KGMP certification:

Korean MFDS (KFDA) device registration: MFDS will not accept biocompatibility testing conducted by well established GLP (ISO17025) accredited laboratories in compliance with ISO10993 and 21 CFR Part 58.
We were told that the KTL will have to conduct new biocompatibility testing. This is incredible because the lab we used is an accredited lab by KOLAS and the testing will be in Korean and useless for anything other than this registration. Further confusion arises when publications indicate that the new 2012 regulations accept ISO standards and MFDS KTL are still using their old test methods.

One of the US labs that we used indicates the following:

"A2LA, KAS (Korea Accreditation System) and KAB (Korea Accreditation Board) are all signatories to IAF (International Accreditation Forum, the world association of Conformity Assessment Accreditation Bodies) and as such accreditation should be recognized through KOLAS. A2LA has had a unified assessment performed by IEC, ILAC and IAF, the whole idea of which is to ensure acceptance of accreditation across the world."

In addition, even TUV SUD Korea, who is recognized by MFDS as a third party reviewer of technical documentation indicates the following in an October 2012 article, South Korea Facilitates Approval, published in E-ssentials TUV Magazine:

"Test reports issued by external laboratories have already been accepted since February 2011, provided they are in compliance with KOLAS (Korean Laboratory Accreditation Scheme, ISO 170245) and issued as CB or GLP Reports. Own tests carried out by KGMP-certified manufacturers are also accepted."

KGMP Certification: Documentation phase completed, audit scheduled for October.

I will pay close attention to the entire process as it appears inconsistent and confusing and needs to be addressed.
 

med_cert

Involved In Discussions
#27
Any new information regarding Korean inspection?
Any special procedures need to be implemented? Where can I find some GMP requirements? Some "device significant change" guidances...? What are the labeling translation requirements? Is English sufficient?
 

Jean_B

Trusted Information Resource
#28
Regulations available (in english) at http://www.mfds.go.kr/eng/brd/m_40/list.do . They're not in a very familiar form though, and for some documents you would need an HWL convert.
GMP requirements can be found under Standards of Medical Device Good Manufacuring Practices (on page 2) in [Attached-Table-2] of 8_Standards_of_Medical_Device_Good_Manufacturing_Practices (Sorry, only 1 link so won't direct link the specific one).
Seems to still be based on 2003/2012 edition but with its share of deviations from it. It contains gems such as "B. All quality records shall be stored to enable instant search within a facility which is able to prevent damage, loss or deterioration." Even seems to have the checklist to be used for the audits embedded at the end.
My own notes say that they are interested in environmental controls & cleanroom, flow and control of goods and work in the details, not the broad strokes. Our last inspection by Korea in 2016 only showed this to be true for the first and second item. It was generally a broad stroke inspection.
 

Wolf.K

Quite Involved in Discussions
#29
If I understand this correctly, the KGMP regulations have been updated for compliance/alignment with ISO 13485:2016?

식품의약품안전처

Unfortunately, there is no English version of the document yet. And, as Jean_B already mentioned, you need a .hwl converter which can be found on the Micrososft homepage.

I wonder if someone, who is on the Korean Market, already performed a gap analysis and can share his/her knowledge with us? For a medical device company fulfilling ISO 13485:2016 and EU GMP regulations, are there any (major) gaps?
 
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