South Korea - draft Medical Device Act Enforcement Regulation

​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.

Categor(ies)y : 11.040 - Medical equipment

Relevant documents:
• MFDS NOTIFICATION No. 2019-60 (2019.2.1.)

Proposed date of adoption: To be determined
Proposed date of entry into force: To be determined
Final date for comments: 60 days from notification