A Review on the Post-Market Surveillance of Medical Devices in the United States and its Implication: A Focus on Real-World Data Using Unique Device Identification of Medical Devices-Reference-Cited by-同舟云学术

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A Review on the Post-Market Surveillance of Medical Devices in the United States and its Implication: A Focus on Real-World Data Using Unique Device Identification of Medical Devices

Published:2023-05-31 Issue:1 Volume:3 Page:22-36
ISSN:1976-4650
Container-title:Health Insurance Review & Assessment Service Research
language:en
Short-container-title:HIRA Research

Author:

Kim Dong-Sook¹^ORCID,Song Inmyung¹^ORCID

Affiliation:

1. Department of Health Administration, Kongju National University, Gongju, Korea

Publisher

Health Insurance Review & Assessment Service Research

Subject

Colloid and Surface Chemistry,Physical and Theoretical Chemistry

Link

http://pdf.medrang.co.kr/HIRA/2023/003/HIRA003-01-02.pdf

Reference35 articles.

1. 의료기기법, 법률 제18319호(2021. 7. 20. 일부개정. 시행 2022. 7. 21).

2. 의료기기법 시행규칙, 총리령 제1841호(2022. 12. 19. 타법개 정. 시행 2022. 12. 19).

3. 의료기기산업 육성 및 혁신의료기기 지원법 시행령, 대통 령령 제30641호(2020. 4. 28. 제정. 시행 2020. 5. 1).

4. Ministry of Food and Drug Safety (2019) 의료기기 부작 용 등 안전성 관리제도.

5. 안기종. 인공고관절 뼈 녹는 부작용, 식약처는 뭐하나? 프레 시안. 2016. 10. 18. Available from: https://www.pressian.com/pages/articles/142787

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