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国家医药管理局于1991年5月1日起对医疗器械新产品实行《医疗器械新产品管理办法》。《办法》的实施将对加强医疗器械新产品的监督管理,促进医疗器械技术水平的提高,保障医疗器械的安全有效,维护人民的健康,有着重大意义。《办法》的主要内容是;统一归口鉴定、分类分级管理、建立管理规范和评审制度、颁发“批准号”等,从而对医疗器械新产品的管理建立三个体系,
On May 1, 1991, the State Administration of Drugs implemented the “Administrative Measures for New Products of Medical Devices” for new medical device products. The implementation of the “Measures” will be of great significance in strengthening the supervision and management of new medical device products, promoting the improvement of medical device technology, ensuring the safety and effectiveness of medical devices, and maintaining the health of the people. The main contents of the Measures are: unified centralized identification, classification and classification management, establishment of management specifications and assessment systems, and issuance of an “approval number” to establish three systems for the management of new medical device products.