Korea | Enforcement Rules on Support, etc. for Innovative Medical Devices

Title of document
Enforcement Rules on Support, etc. for Innovative Medical Devices (55 page(s), in Korean)

Description
The enforcement rules prescribe the procedures and methods for modular review and priority review of medical devices which aim to support the development and commercialization of innovative medical devices.

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/869

Objective tag
Other

Objective
Adoption of Domestic regulation following the enactment and publishing of the Act

Documents

• 19_7231_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• Submission: 16/12/2019
• Reception: 16/12/2019
• Distribution: 16/12/2019
• Final date for comments: 14/02/2020
• Proposed date of adoption: N/A