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번호 제목 작성자 날짜 조회수
26 The First Provisional Insurance Registration on AI-based SaMD (Innovative Medical Technology Determined) MDREX 2023-12-26 243
25 MFDS Plans to Expand Recognition of Data on Biological Safety MDREX 2023-12-19 242
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 2023-10-20 303
23 [MDREX] Introduction to Korean National Health Insurance Reimbursement System Guidelines for Digital Therapeutics (DTx) at APACMed Webinar MDREX 2023-10-13 354
22 [MDREX] New Professionals Joined! MDREX 2023-09-07 292
21 Announcement of Plans to Apply National Health Insurance Coverage to DTx devices and AI medical devices 관리자 2023-08-12 318
20 [MFDS] Amendment to the Notice of New Category of Medical devices 관리자 2023-07-04 353
19 New Guidelines on addresses of manufacturing sites for KGMP 관리자 2023-06-16 305
18 Pilot Project on Non-Face to Face Treatment(Telemedicine) Begins June 1, 2023. 관리자 2023-06-06 348
17 New Legislation on Digital Health Products 관리자 2023-05-29 311
16 MFDS accepts RWE for medical device with 3D printer or digital technology(wearable, big data, AI etc.) 관리자 2023-05-15 332
15 SaMD products that identify type of cerebral stroke utilizing MR images designated as "innovative medical technology" 관리자 2023-05-10 244
14 2023 Medical Device Expenditure Report Audit Plans by the MOHW 관리자 2023-04-25 280
13 [MDREX Newsletter] A brief for medical device export procedure to Korea. 관리자 2023-04-12 352
12 Notice of partnership between MDREX and RQS 관리자 2023-03-30 323