在市场经济条件下重振医疗器械标准化工作

Revive the Standardization Work of Medical Devices under the Market Economics

叙述新时期的标准化工作的内涵和重要意义及法律责任,认定医疗器械标准是技术基础工作,是行政监督的主要的技术支持。介绍了国内医疗器械标准化工作的现状,并就全面推进医疗器械标准化工作提出各项要求。

This paper narrates the connotation, the great significance and legal responsibilities of the standardization work in the new stage, and firmly believe that medical devices' standardization is a fundamental work of technology, and is a basic technological support for administrative supervision as well. Besides, the paper introduces to you the present state of medical device standard work in China and presents some demands and requirements for pushing on this important work.