• October 1, 2020
  • WTO

Korea | Amendments to the Enforcement Rule of the Medical Devices Act

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Title of document
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: To adjust fees such as medical device licenses and examinations according to the inflation rate To increase personnel for professional reviews in response to the increase in the number of high-tech products To revise provisions on the fees for medical device approvals and reviews in order to expedite the approval and review processes

Notifying member: Korea, Republic of


Objective tag

The amendments aim to address the limitations found in the operation of the Act


Agency responsible
Ministry of Food and Drug Safety


  • Submission: 28/09/2020
  • Reception: 28/09/2020
  • Distribution: 30/09/2020
  • Final date for comments: 26/10/2020
  • Proposed date of adoption: N/A


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