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Newsletter
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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
138
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
149
47
Re-announcement of Enforcement Rules for the Digital Medical Products Act
MDREX
2024-11-05
333
46
Regulatory Updates Pertaining to Medical Device Companies Part II
MDREX
2024-10-30
161
45
Recent Regulatory Updates Pertaining to Medical Device Companies
MDREX
2024-10-22
243
44
MDREX Hosts Seminar on Upcoming Digital Medical Products Act: Implementation Scheduled for January 24, 2025
MDREX
2024-10-14
176
43
MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act”
MDREX
2024-09-24
136
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
185
41
MFDS Announces Legislative Notice for Enforcement Decrees and Enforcement Rules of the Digital Medical Products Act
MDREX
2024-08-08
390
40
[MDREX Newsletter] MFDS reduces subject with medical device supply history reporting duty… effective from reporting for June
MDREX
2024-08-02
310
39
MDREX, Introducing Improvements in Japanese Insurance Regulations for SaMD Products.
MDREX
2024-07-24
256
38
MDREX Welcomes Mr. Wonwoo LEE as Vice President (COO) to Support Innovative Medical Device Exports
MDREX
2024-07-15
213
37
[MDREX Newsletter] Designation Status of Innovative Medical Technologies and Methods for Determining the Maximum Amount for Selective ReimbursementNon-Reimbursement
MDREX
2024-06-27
248
36
MDREX, Implementation of Renewal for Medical Device Product Approval/Certification/Notification by the Ministry of Food and Drug Safety
MDREX
2024-06-13
445
35
MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan
MDREX
2024-05-23
235
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