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China Medical Device Regulations – An Overview

The medical devices regulatory system is based on regulations issued by the State Council, NMPA orders and NMPA documents that provide detailed rules for medical device registration and licensing practice. Medical device type testing must be based upon the Chinese National Standard (Chinese: Guobiao, GB) or at least on an Industry Standard (YY). The system is undergoing frequent changes and adjustments. In October 2013, more than 104 new YY Stand… WebThe International Medical Device Regulators Forum (IMDRF) is a group of medical device regulators from around the world that have voluntarily come together to harmonize the … great minds don\u0027t think alike

Katarzyna Chrusciel M. - Quality and EU Regulatory Manager

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