Korea | Amendment of “Regulation on medical device group and class by group”

Title of document
Amendment of “Regulation on medical device group and class by group” (51 page(s), in Korean)

Description
The Republic of Korea is proposing to amend the “Regulation on medical device group and class by group”. The main changes proposed are:  1) ‘Respirator, medical’ as medical device was newly classified  2) The number of software as medical devices were expanded from 8 to 90 considering clinical field

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/917

Objective tag
Protection of human health or safety

Objective
Promoting the health and safety of medical professionals and improving the management of medical devices

Documents

• 20_5645_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• Submission: 22/09/2020
• Reception: 22/09/2020
• Distribution: 22/09/2020
• Final date for comments: 21/11/2020
• Proposed date of adoption: N/A