KOR/1170
WTO/TBT
KR South Korea
  • 11 - Health care technology
2023-10-05
2023-09-15

Medical devices

Proposed amendment of the "Regulations on Renewal of Manufacturing Permission, etc."; (13 page(s), in Korean)

The Korean Ministry of Food and Drug Safety is proposing to amend the "Regulations on Renewal of Manufacturing Permission, etc." as follows:

1) Reorganizing the requirement attached documents considering the characteristics of each medical device product

2) Incorporating key review points for each renewal cycle, etc.