Standards and testing in Korea
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The document discusses standards and regulations for medical device testing and certification in Korea. It covers searching local Korean standards, deviations from international standards, different certification schemes for active and non-active products (CB scheme for active, GLP for non-active), requirements for quality management systems, and considerations for testing products in Korea directly.
Standards and testing in Korea
- 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
- 6. Local standards search Pay attention to following attributes: Identical(IDT), Modified(MOD), Not Equivalent(NEQ)
- 10. Local deviations Power requirements in Korea: 220V single phase 60Hz 380V tri-phase
- 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
- 27. GLP GLP = Good Laboratory Practice
- 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
- 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
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