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Research and Reflection on Reprocessed Medical Devices Supervision / 中国医疗器械杂志
Zhongguo Yi Liao Qi Xie Za Zhi ; (6): 286-288, 2018.
Article en Zh | WPRIM | ID: wpr-689808
Biblioteca responsable: WPRO
ABSTRACT
Under the precondition of ensuring safety and effectiveness, whether to reuse reprocessed medical devices to reduce the medical expenses has become the focus of the relevant regulatory authorities in our country. In this paper, we studied the regulatory policy for reprocessed medical devices in major international economies, such as United States, Japan, European Union and so on. From the regulatory and technical level, we thought about the risks of supervising reprocessed medical devices, and analyzed the ideas and risk concerns of supervising reprocessed medical devices to provide reference for regulation of such devices in our country.
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Texto completo: 1 Base de datos: WPRIM Asunto principal: Estados Unidos / Equipo Reutilizado / Seguridad de Equipos País/Región como asunto: America do norte Idioma: Zh Revista: Zhongguo Yi Liao Qi Xie Za Zhi Año: 2018 Tipo del documento: Article
Texto completo: 1 Base de datos: WPRIM Asunto principal: Estados Unidos / Equipo Reutilizado / Seguridad de Equipos País/Región como asunto: America do norte Idioma: Zh Revista: Zhongguo Yi Liao Qi Xie Za Zhi Año: 2018 Tipo del documento: Article