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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
209
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
168
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
150
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
155
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
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