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19
New Guidelines on addresses of manufacturing sites for KGMP
관리자
2023-06-16
132
18
Pilot Project on Non-Face to Face Treatment(Telemedicine) Begins June 1, 2023.
관리자
2023-06-06
135
17
New Legislation on Digital Health Products
관리자
2023-05-29
131
16
MFDS accepts RWE for medical device with 3D printer or digital technology(wearable, big data, AI etc.)
관리자
2023-05-15
120
15
SaMD products that identify type of cerebral stroke utilizing MR images designated as "innovative medical technology"
관리자
2023-05-10
105
14
2023 Medical Device Expenditure Report Audit Plans by the MOHW
관리자
2023-04-25
134
13
[MDREX Newsletter] A brief for medical device export procedure to Korea.
관리자
2023-04-12
169
12
Notice of partnership between MDREX and RQS
관리자
2023-03-30
152
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
115
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
136
9
MFDS(= Korea FDA) recently amended the "Basic Guidelines on the Operation of K-GMP Certification(January 30, 2023)"
관리자
2023-03-08
111
8
Liability insurance coverage for implantable medical devices (i.e., products that last more than 30 days in the body) has become mandatory as of January 20, 2023
관리자
2023-03-01
101
7
MOHW announced the amended "Guidelines on Utilizing Medical Health Data"
관리자
2023-03-01
124
6
MFDS issues clinical assessment guidelines for DTx products aimed at treating depression etc.
관리자
2023-01-31
143
5
[Legislature and Ministry of Health & Welfare] Graded Reimbursement for Non Face-to-Face Treatment
관리자
2023-01-18
140
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