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번호 제목 작성자 날짜 조회수
9 MFDS(= Korea FDA) recently amended the "Basic Guidelines on the Operation of K-GMP Certification(January 30, 2023)" 관리자 2023-03-08 132
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 2023-03-01 121
7 MOHW announced the amended "Guidelines on Utilizing Medical Health Data" 관리자 2023-03-01 148
6 MFDS issues clinical assessment guidelines for DTx products aimed at treating depression etc. 관리자 2023-01-31 168
5 [Legislature and Ministry of Health & Welfare] Graded Reimbursement for Non Face-to-Face Treatment 관리자 2023-01-18 165
4 Usability Engineering Report required for all SaMD product license applications starting in 2023 관리자 2023-01-11 144
3 SaMD used for CDSS Approved for National Health Insurance/Reimbursement in Korea 관리자 2023-01-03 144
2 MOHW and HIRA national health insurance registration of "NGS-CDx tests for non-small cell carcinoma" 관리자 2022-12-20 137
1 New MFDS Regulations on Marketing/Advertising of ClinicalTrial Results for Medical Devices 관리자 2022-12-13 176