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

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

Description
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

Notification: G/TBT/N/KOR/922

Objective tag
Other

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

Documents

• 20_5781_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• 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