| 16 |
국내 |
규제 |
[식품의약품안전처] 의료기기법 시행규칙 일부개정령(안) 입법예고(식약처 공고 제2024-620호)
|
2024-01-05 |
| 15 |
미국 |
소식지 |
[보건산업브리프 347호] 한국기업 미국 의료기기 시장 진출을 위한 FDA 의료기기 인허가 가이드북
|
2024-01-04 |
| 14 |
유럽 |
지침 |
Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.
|
2023-12-19 |
| 13 |
유럽 |
지침 |
Team-NB-PositionPaper-CyberSecurity-V1.
|
2023-12-19 |
| 12 |
유럽 |
지침 |
Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2.
|
2023-12-19 |
| 11 |
유럽 |
지침 |
[MDCG 2023-3] Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
|
2023-12-19 |
| 10 |
유럽 |
지침 |
[MDCG 2022-14] Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs
|
2023-12-19 |
| 9 |
유럽 |
지침 |
[MDCG 2022-13] Designation, re-assessment and notification of conformity assessment bodies and notified bodies
|
2023-12-19 |
| 8 |
유럽 |
지침 |
[MDCG 2022-4] Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
|
2023-12-19 |
| 7 |
미국 |
지침 |
FDA_Guidance-ISO 10993-1
|
2023-12-19 |
