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星海会展国际医疗器械设计与制造法律专辑 （2007·2 总第10期） 本期要目 论中案 国际医疗器械设计与制造专辑 目 录 理论研究 对《医疗器械临床试验规定》的解读·················································································1 论中美医疗器械监管的比较与分析······················································································4 案例分析 上海宝山宝康医疗电子仪器厂诉上海宝康科技有限公司案············································································································18 康达医疗保健用品公司诉西北工商报社、陕西省医疗器械公司侵害法人名誉权纠纷案····················································································································································20 法律法规 医疗器械监督管理条例················································································································22 医疗器械临床试验规定················································································································27 行业资讯 2007年1-2月中国进口“心脏起博器，不包括零件、附件”综合信息········································32 2007年家庭医疗器械市场生变····································································································32 涉外动态 Regulations and Market Development for Medical Device in China…………... …….. ….34 辽宁盛和律师事务所简介········································································································封底 International Medical Equipment Design and Manufacture Contents Study of Theory Comment on “Provisions for Clinical Trials of Medical Devices” ………………………1 Compare and Analyse the Sino-America Medical Device Administration…….………..4 Case Study SH-Baokang v. SH Baokang Scie Tech.Co., Ltd………………………………………12 Qiu Shiyu v. Harbin Public Medical Health Articles Factory……………………….18 Kang Da Medical Health Articles. Co., Ltd v. Northwest IndustryCommerce Newspaper Office and Shanxi Medical Instruments Co., Ltd………………………….20 Rules and Regulations Regulations on Supervision And Management to Medical Instruments………. ……. .22 Provisions for Clinical Trials of Medical Devices…………………………….. ……. ….27 Industry Information The General Information about Chi