医疗器械行业标准相关问题的探讨

Discussion about medical device industrial standards

介绍了国外医疗器械行业标准的管理经验,简述了国内医疗器械行业标准的发展,分析了医疗器械法规与强制性标准、技术法规与强制性行业标准以及强制性行业标准滞后与医疗器械技术进步之间的问题,指出了现行的强制性行业标准体系已经不适应医疗器械监管的新形势。提出了医疗器械行业标准建设的几点建议,期望能准确定位行业标准在医疗器械监管中的地位与作用,发挥行业标准的技术支撑作用。

The management experience of medical device industrial standards was introduced in foreign countries. The progress of medical device industrial standards was summarized in China, and the problems were analyzed between medical device law and compulsory standards, technical regulation and compulsory industrial standards as well as the lagging of compulsory industrial standard and the development of medical device technology. It's pointed out the existing compulsory industrial standard system could not meet the requirements of medical device supervision. Some suggestions were put forward for the development of medical device industrial standard so as to make industrial standard as the technical support for medical device supervision.