KOR/788
WTO/TBT
KR Südkorea
  • 11 - Medizintechnik
2018-12-10
2018-10-15

Medical Devices; Medical equipment (ICS 11.040).

Amendment of "Standards of Medical Device Good Manufacturing Practices" (83 page(s), in Korean)

ISO13485:2016 adoption, additional submission requirements for QMS audits, overhaul of terminology definition and form revision of audit applications and reports, etc