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国家医药管理局局长齐谋甲签发第4号国家医药管理局令,《医疗器械新产品管理暂行办法》(以下简称“办法”)将于一九九一年五月一日起执行。“办法”分七章三十七条。第一章总则中指出:凡是从事医疗器械新产品研制、生产的单位和个人必须遵守本办法。“办法”中所指的“医疗器械”是用于人体疾病诊断、治疗、预防,调节人体生理功能或替代人体器官的仪器、设备、装置、器具、
The Director of the State Administration of Pharmacy Qi Youmou issued the Order No. 4 of the State Administration of Pharmacy, “Interim Measures for the Management of New Products for Medical Devices” (hereinafter referred to as the “Measures”) will be implemented starting May 1, 1991. “Methods” are divided into seven chapters and 37 articles. Chapter 1, General Provisions, states that all units and individuals engaged in the development and production of new medical device products must comply with these Measures. The “medical device” referred to in the “approach” is an apparatus, apparatus, device, and apparatus for diagnosing, treating, and preventing human diseases, regulating human physiological functions, or replacing human organs.