Standards and testing in Korea

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Describes the process of standards recognition and testing in Korea for medical devices

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  • Standards and testing in Korea

    1. 1. Presented by Nicolas Clary (Kobridge Consulting Ltd.)
    2. 2. Agenda :  Local standards search  Local deviations  Standards recognition  CB scheme  GLP (Good Laboratory Practice)  Quality system and KGMP  Testing in Korea
    3. 3. Local standards search Go to KSSN (Korean Standard Service network) webstore: http://kssn.net/English/WebStor e/C_WebStore_list.asp
    4. 4. Local standards search
    5. 5. Local standards search Pay attention to following attributes:  Identical(IDT), Modified(MOD), Not Equivalent(NEQ)
    6. 6. Local deviations
    7. 7. Local deviations
    8. 8. Local deviations Power requirements in Korea: 220V single phase 60Hz 380V tri-phase
    9. 9. Standards recognition Standards Product Active Active Quality system KGMP
    10. 10. Active products must follow CB scheme
    11. 11. CB scheme MAKE SURE local deviations are implemented before testing and verify during testing. The report should reflect it.
    12. 12. CB scheme Is your test lab IECEE member ?
    13. 13. CB scheme Confirm it on IECEE website: IECEE members section
    14. 14. CB scheme
    15. 15. CB scheme
    16. 16. CB scheme Class 1 & 2 Class 3 & 4 Good recognition of CB reports (by 3rd parties) Poor recognition of CB reports (by MFDS)
    17. 17. CB scheme
    18. 18. CB scheme
    19. 19. CB scheme
    20. 20. CB scheme
    21. 21. Non Active products must follow GLP
    22. 22. GLP GLP = Good Laboratory Practice
    23. 23. GLP For instance: biocompatibility
    24. 24. GLP GLP follow FDA 21CFR part 58
    25. 25. GLP
    26. 26. GLP
    27. 27. GLP
    28. 28. GLP
    29. 29. GLP
    30. 30. GLP
    31. 31. GLP
    32. 32. Quality system ISO 13485 = recognized w/o deviation
    33. 33. Quality system In fact: whole standard copied in the medical act
    34. 34. Testing in Korea Sometimes the best option
    35. 35. Testing in Korea When considering testing in Korea ?
    36. 36. Testing in Korea Korea is a major market for you No budget for CB report Class 3 or 4 product
    37. 37. Testing in Korea List of labs (around 14) KTR KTC KCL KTRI University based labs
    38. 38. Testing in Korea Price range: EMC around 700 USD Electrical safety 3000 USD Biocompatibility 10000 USD
    39. 39. Nicolas Clary Kobridge Consulting +82 2 3450 1690 Nicolas.clary@kobridgeconsulting.com www.kobridgeconsulting.com

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