Has anyone had sudden challenges from Korea-MFDS?

#1
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!
 
Elsmar Forum Sponsor

Sicco

Involved In Discussions
#2
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.
 
Thread starter Similar threads Forum Replies Date
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
T Has anyone completed the AS9100D Quality Manual transition? Quality Management System (QMS) Manuals 1
D Has anyone taken the AS9100 Delta course / exam? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
D Medica show in Dusseldorf - Has anyone else gone? Other Medical Device and Orthopedic Related Topics 3
A AS9100C to D - Has anyone done a gap analysis? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Has anyone been through the ISO 14001:2015 process? ISO 14001:2015 Specific Discussions 12
Marc Has anyone here gotten Gigabyte Fiberoptics (Internet) to home? Coffee Break and Water Cooler Discussions 3
M Has anyone had their electronic system scrutinized in an FDA inspection? Records and Data - Quality, Legal and Other Evidence 16
P Has anyone ever heard of the Eastern Weighing and Inspection Bureau? Calibration and Metrology Software and Hardware 1
M Has anyone successfully challenged the new IATF site extension change? IATF 16949 - Automotive Quality Systems Standard 36
R Does anyone know why the TC 176 website has been hijacked by CSA? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
GStough Rx-360 - Has Anyone Used This and What Was Your Experience? Supplier Quality Assurance and other Supplier Issues 3
A Has anyone made an ISO9001:2015 vs. ISO9001:2008 Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
I Has anyone read BIP 0115:2014? ISO 13485:2016 - Medical Device Quality Management Systems 5
D ?Pa? Capability Index - Has anyone ever heard of this? Capability, Accuracy and Stability - Processes, Machines, etc. 5
optomist1 Has anyone recently taken the GD&T ASME Y14.5M Certification Exam Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T Has anyone considered what logic is? Coffee Break and Water Cooler Discussions 23
Jim Wynne Has Anyone Had Trouble with IMDS 8.0? RoHS, REACH, ELV, IMDS and Restricted Substances 17
G Has anyone used shlomo Aviv-lean consultant? Lean in Manufacturing and Service Industries 1
M Has anyone purchased their powerball tickets? 17 May 2013 Coffee Break and Water Cooler Discussions 8
T Has anyone done both Quality and Facility Security Officer (FSO) roles ? Career and Occupation Discussions 8
M Has anyone used SGS as a CB (Certification Body)? Registrars and Notified Bodies 4
R Mix Multi-Site/Individual Certification - Has this ever happened to anyone? Miscellaneous Environmental Standards and EMS Related Discussions 14
B Has anyone used Arena Software Simulation? Process Maps, Process Mapping and Turtle Diagrams 10
C Has anyone used GageWare Software? Quality Assurance and Compliance Software Tools and Solutions 4
M Has anyone used "Paradigm 3" software to Control their Quality or Management System? Quality Tools, Improvement and Analysis 2
Q Has Anyone Heard of Quality University (Online Courses) Training - Internal, External, Online and Distance Learning 2
P Has anyone ever heard of "Quality Gates" (Volkswagen term?) - APQP and PPAP APQP and PPAP 11
A Has anyone tried a DAC (Digital to Analog Converter)? After Work and Weekend Discussion Topics 5
I Has anyone ever heard of Registrar QSRD-International? Registrars and Notified Bodies 36
M Has anyone of you have experience with the World Class Manufacturing system? Lean in Manufacturing and Service Industries 6
K Does anyone has experience with determining if Lubricants and Greases are Food Grade? Food Safety - ISO 22000, HACCP (21 CFR 120) 6
R SOPs in Manufacturing - Has anyone got a management process that works? Document Control Systems, Procedures, Forms and Templates 4
K Has anyone had experience dealing with SEDEX (Supplier Ethical Data Exchange)? Customer and Company Specific Requirements 4
B Has anyone developed an OHSAS 18001 Safety Management System Balanced Scorecard? Occupational Health & Safety Management Standards 13
D Has anyone used Mango as their Quality Software? Quality Assurance and Compliance Software Tools and Solutions 9

Similar threads

Top Bottom