Korea | Amendments to the "Enforcement Regulation of the Medical Devices Act"

Title of document
Amendments to the "Enforcement Regulation of the Medical Devices Act" (28 page(s), in Korean)

Description
The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is amending the "Enforcement Regulation of the Medical Devices Act" as stated below: When supply interruptions become predictable for essential medical devices for public healthcare, manufacturers and importers of the devices shall be mandated to report to the Minister of Food and Drug Safety. An administrative disposition on false and misleading advertisement shall be introduced to regulate any actors engaging in marketing activities with exaggerated spoken language or performances trying to sell medical devices for purposes other than their original purposes, approved by the MFDS.

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/861

Objective tag
Protection of human health or safety

Objective
The amendments aim to promote reliable supply and safe management of medical devices.

Documents

• 19_5309_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• Submission: 27/09/2019
• Reception: 27/09/2019
• Distribution: 04/10/2019
• Final date for comments: 29/11/2019
• Proposed date of adoption: N/A