Um estudo comparativo das perspectivas regulatórias sobre dispositivos médicos inovadores na Coreia e nos Estados Unidos.
PMID: 35293274 ·
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Resumo
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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