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번호 제목 작성자 날짜 조회수
49 Procedures for Immediate Entry of the Medical Device Market, Mandatory Registration of Medical Device Contract Sales Organizations (CSO), and the Second Proposed Amendment of the Digital Medical Products Act MDREX 2024-12-04 140
48 New Administration Pre-Announcements of Proposed Amendments to the Administrative Rules for In Vitro Diagnostic Medical Device Permit and Medical Device Labeling Requirements MDREX 2024-11-19 152
47 Re-announcement of Enforcement Rules for the Digital Medical Products Act MDREX 2024-11-05 337
46 Regulatory Updates Pertaining to Medical Device Companies Part II MDREX 2024-10-30 165
45 Recent Regulatory Updates Pertaining to Medical Device Companies MDREX 2024-10-22 245
44 MDREX Hosts Seminar on Upcoming Digital Medical Products Act: Implementation Scheduled for January 24, 2025 MDREX 2024-10-14 179
43 MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act” MDREX 2024-09-24 138
42 Announcement of the Amendment (draft) to the Medical Devices Act on the Scope and Method of Relief for Damages caused by Medical Device Adverse Events. MDREX 2024-08-26 188
41 MFDS Announces Legislative Notice for Enforcement Decrees and Enforcement Rules of the Digital Medical Products Act MDREX 2024-08-08 404
40 [MDREX Newsletter] MFDS reduces subject with medical device supply history reporting duty… effective from reporting for June MDREX 2024-08-02 315
39 MDREX, Introducing Improvements in Japanese Insurance Regulations for SaMD Products. MDREX 2024-07-24 258
38 MDREX Welcomes Mr. Wonwoo LEE as Vice President (COO) to Support Innovative Medical Device Exports MDREX 2024-07-15 217
37 [MDREX Newsletter] Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective ReimbursementNon-Reimbursement MDREX 2024-06-27 262
36 MDREX, Implementation of Renewal for Medical Device Product Approval/Certification/Notification by the Ministry of Food and Drug Safety MDREX 2024-06-13 452
35 MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan MDREX 2024-05-23 239