Ce diaporama a bien été signalé.
Nous utilisons votre profil LinkedIn et vos données d’activité pour vous proposer des publicités personnalisées et pertinentes. Vous pouvez changer vos préférences de publicités à tout moment.

Standards and testing in Korea

1 241 vues

Publié le

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

Publié dans : Santé
  • Soyez le premier à commenter

  • Soyez le premier à aimer ceci

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

×