Newsletter

 
번호 제목 작성자 날짜 조회수
24 National Assembly (“NA”) Audit of the Ministry of Health and Welfare (“MOHW”) and Food and Drug Safety (“MFDS”), Expected Digital Medical Device Regulatory Improvements, and Expanding Causality Investigations MDREX 2023-10-20 160
23 [MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar MDREX 2023-10-13 138
22 [MDREX] New Professionals Joined! MDREX 2023-09-07 179
21 Announcement of Plans to Apply National Health Insurance Coverage to DTx devices and AI medical devices 관리자 2023-08-12 168
20 [MFDS] Amendment to the Notice of New Category of Medical devices 관리자 2023-07-04 208
19 New Guidelines on addresses of manufacturing sites for KGMP 관리자 2023-06-16 159
18 Pilot Project on Non-Face to Face Treatment(Telemedicine) Begins June 1, 2023. 관리자 2023-06-06 167
17 New Legislation on Digital Health Products 관리자 2023-05-29 159
16 MFDS accepts RWE for medical device with 3D printer or digital technology(wearable, big data, AI etc.) 관리자 2023-05-15 149
15 SaMD products that identify type of cerebral stroke utilizing MR images designated as "innovative medical technology" 관리자 2023-05-10 127
14 2023 Medical Device Expenditure Report Audit Plans by the MOHW 관리자 2023-04-25 154
13 [MDREX Newsletter] A brief for medical device export procedure to Korea. 관리자 2023-04-12 190
12 Notice of partnership between MDREX and RQS 관리자 2023-03-30 179
11 A brief of "requirements for clinical trial data" accepted by the Ministry of Food and Drug Safety ("MFDS", Korea FDA) 관리자 2023-03-22 133
10 A brief outline below on the key questions that are raised when determining whether a product is a medical device as well as the administrative procedures for submitting a written inquiry 관리자 2023-03-15 159