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WHO Global Model Regulatory Framework for Medical Devices includi...

世卫组织医疗器械(包括体外诊断医疗器械)全球模型监管框架

【作       者】:

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【机       构】: 世界卫生组织
【承研机构】:

【原文地址】: https://www.who.int/publications/i/item/9789241512350
【发表时间】:

2017-09-05

摘要

The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).

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