PubMed

关于韩国和美国创新医疗设备的监管视角的比较研究。

PMID：35293274 · 2022-03-17

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期刊Expert review of medical devices

年份2022-03-17

PMID35293274

摘要

As the 4th Industrial Revolution era emerges, medical devices that apply technologies such as big data, artificial intelligence, and 3D printers are on the rise. In April 2019, Korea introduced the Act on Nurturing Medical Devices Industry and Supporting Innovative Medical Devices to shorten the market entry time by conducting step-by-step screening through the designation of innovative medical devices, priority screening systems, and special permission screening systems. In this study, the Brea

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