Korea - “Medical Device Act Enforcement Regulation”

Title of document
“Medical Device Act Enforcement Regulation” (41 page(s), in Korean)

Description
Following the amendment to the Medical Device Act on 11 December 2018, its subordinate legislation, “Medical Device Act Enforcement Regulation”, has been amended to include the following : a. foreign bodies that should be reported, time limit and procedures for report, actions taken to the reported, etc. b. preparations for and scope of on-site inspection in foreign medical devices establishments, actions applied to medical devices with potential risks, procedures to lift the imposed restrictions, etc.

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/811

Objective tag
Protection of human health or safety

Objective
It aims to : a. protect public health against adverse events caused by unintended foreign bodies in medical devices; and b. enhance effectiveness of post market surveillance for medical devices

Documents

• 19_0888_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• Submission: 14/02/2019
• Reception: 14/02/2019
• Distribution: 15/02/2019
• Final date for comments: 16/04/2019
• Proposed date of adoption: N/A