KR Südkorea
  • 11 - Medizintechnik

Medical Devices

Amendments to the "Enforcement Rule of the Medical Devices Act" (11 page(s), in Korean)

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is amending the "Enforcement Rule of the Medical Devices Act" for the following purposes:

1.    To adjust fees such as medical device licenses and examinations according to the inflation rate

2.    To increase personnel for professional reviews in response to the increase in the number of high-tech products

3.    To revise provisions on the fees for medical device approvals and reviews in order to expedite the approval and review processes