Has anyone had sudden challenges from Korea-MFDS?


We recently submitted a change notification related to added instrumentation to our labeling and MFDS has a new reviewer who decided to ask for essentially the entire technical file for the assay (which was unchanged). The reviewer has been totally unreasonable and is expecting new QC of existing released lots with every revision change in QC SOP or change in release forms with threats of removal from market if we cannot provide evidence. Anyone who works in industry is fully aware that these things changed with relative frequency and that an assessment of impact of that change is completed prior to implementation. I suspect that they have done something similar to one of our competitors as they forced one of their products off the market which is CE marked and available globally. We have the perception that, like China, they are getting increased pressure to push US companies out of the country to make room for locally manufactured products but we cant really confirm that.

Has anyone else had similar experiences with MFDS in Korea? This seems like a recent change. They have always been a fairly strict market in terms of document reviews but they seem to have gone to the extreme and are now our most challenging country in terms of technical reviews. We would really like to get an idea if this is one problematic reviewer or a change within MFDS as a whole.

Thanks in advance!


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What I have noticed is that the previous generation of experienced auditors has gone from MFDS (or doing better jobs now) and now there are many new, fresh and less experienced but all the more strict auditors who have unreasonable and very complex (and also OP) requirements, but unfortunately we (as manufacturers/registrants) can't do much with it, if we want to implement changes. Perhaps it is a new trend in Asia because I have similar reactions from registrations and implementation of changes from most of Asian countries.
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