Korea | Establishment of "Regulation on Integrated Management of Medical Device Information"

Title of document
Establishment of "Regulation on Integrated Management of Medical Device Information" (7 page(s), in Korean)

Description
A list of required information and guidance for manufacturers or importers on how to insert data into the database "Integrated Medical Device Information System (IMDIS)"

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/830

Objective tag
Protection of human health or safety

Objective
Protection of Human health or Safety (Improving public health by reinforcing safety management for invasive medical devices.)

Documents

• 19_2747_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• Submission: 09/05/2019
• Reception: 09/05/2019
• Distribution: 09/05/2019
• Final date for comments: 08/07/2019
• Proposed date of adoption: N/A