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

1. Presented by Nicolas Clary
(Kobridge Consulting Ltd.)

2. Agenda :
 Local standards search
 Local deviations
 Standards recognition
 CB scheme
 GLP (Good Laboratory Practice)
 Quality system and KGMP
 Testing in Korea

4. Local standards search
Go to KSSN (Korean Standard
Service network) webstore:
http://kssn.net/English/WebStor
e/C_WebStore_list.asp

5. Local standards search

6. Local standards search
Pay attention to following
attributes:
 Identical(IDT), Modified(MOD), Not
Equivalent(NEQ)

8. Local deviations

9. Local
deviations

10. Local deviations
Power requirements in Korea:
220V single phase
60Hz
380V tri-phase

12. Standards recognition
Standards
Product
Active Active
Quality
system
KGMP

14. Active
products
must
follow CB
scheme

15. CB scheme
MAKE SURE local deviations are
implemented before testing and
verify during testing.
The report should reflect it.

16. CB scheme
Is your test lab IECEE member ?

17. CB scheme
Confirm it on IECEE website:
IECEE members section

18. CB scheme

19. CB scheme

20. CB scheme
Class 1 & 2 Class 3 & 4
Good
recognition of
CB reports (by
3rd parties)
Poor
recognition of
CB reports (by
MFDS)

21. CB scheme

22. CB scheme

23. CB scheme

24. CB scheme

26. Non
Active
products
must
follow
GLP

27. GLP
GLP = Good Laboratory Practice

28. GLP
For instance: biocompatibility

29. GLP
GLP follow FDA 21CFR part 58

30. GLP

31. GLP

32. GLP

33. GLP

34. GLP

35. GLP

36. GLP

38. Quality system
ISO 13485 = recognized w/o
deviation

39. Quality system
In fact: whole standard copied in
the medical act

41. Testing in
Korea
Sometimes
the best
option

42. Testing in Korea
When considering testing in
Korea ?

43. Testing in Korea
Korea is a major market for you
No budget for CB report
Class 3 or 4 product

44. Testing in Korea
List of labs (around 14)
KTR
KTC
KCL
KTRI
University based labs

45. Testing in Korea
Price range:
EMC around 700 USD
Electrical safety 3000 USD
Biocompatibility 10000 USD

46. Nicolas Clary
Kobridge Consulting
+82 2 3450 1690
Nicolas.clary@kobridgeconsulting.com
www.kobridgeconsulting.com