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People's Procuratorate of Minhang District, Shanghai Municipality v. Bian Fei (A case of illegal operation)
上海市闵行区人民检察院诉卞飞非法经营案
【法宝引证码】
 
  
People's Procuratorate of Minhang District, Shanghai Municipality v. Bian Fei (A case of illegal operation) 上海市闵行区人民检察院诉卞飞非法经营案
 
[Judgment Abstract] [裁判摘要]
The people's court should determine acts of illegal operation in accordance with the provisions of laws and regulations. For an internal document of an administrative organ, the people's court should comprehensively examine whether it complies with the relevant provisions of administrative laws and regulations and may not determine that the acts of an actor constitute a crime only on the basis of such internal document. 人民法院认定非法经营行为,应依据行政法律、法规的规定,对于行政机关内部文件,应当全面审查其是否符合行政法律法规的相关规定,不得单独据以认定行为人的行为构成犯罪。
Public prosecution organ: People's Procuratorate of Minhang District, Shanghai Municipality. 公诉机关:上海市闵行区人民检察院。
Defendant: Bian Fei. He was criminally detained on suspicion of committing the crime of illegal operation on April 26, 2017, granted bail on June 1 of the same year, arrested on December 8 of the same year, and granted bail again on December 9 of the same year. 被告人:卞飞。因涉嫌犯非法经营罪于2017年4月26日被刑事拘留,同年6月1日被取保候审,同年12月8日被逮捕,同年12月9日被取保候审。
The People's Procuratorate of Minhang District, Shanghai Municipality instituted a public prosecution to the Primary People's Court of Minhang District, Shanghai Municipality on the ground that defendant Bian Fei committed the crime of illegal operation. 上海市闵行区人民检察院以被告人卞飞犯非法经营罪,向上海市闵行区人民法院提起公诉。
According to the charging instrument, from July 2015, in the course of operating Shanghai Huihai Electronic Equipment Co., Ltd. (hereinafter referred to as "Huihai Company") by defendant Bian Fei, a series of bioenergy meters with models of SE-F1, SE-F2, and SE-F3 were produced and such bioenergy meters were sold by Shanghai Mingzhu Medical Science and Technology Development Co., Ltd. (hereinafter referred to as "Mingzhu Company"). A total of 182 sets of SE-series of bioenergy meters were accumulatively sold, with the total amount of 924,270 yuan. According to the reply of the China Food and Drug Administration (hereinafter referred to as the "CFDA"), the SE-series of bioenergy meters were determined as medical devices of Class II. In the Testing Report issued by Wuhan Product Quality Supervision & Testing Institute under the National Center for Quality Supervision and Inspection of Infrared and Industrial Electric Heating Products, the relative radiation spectra (wavelength range of infrared radiation) of the SE-series of bioenergy meters and Harbin Quanke therapeutic equipment were tested. In December 2016, the administrative law enforcement department seized 127 sets of SE-series of bioenergy meters involved with the value of 581,740 yuan. In violation of the state provisions, Bian Fei operated goods whose trading was restricted by laws and administrative regulations without licensing. His acts disturbed the market order, fell under serious circumstances, and constituted the crime of illegal operation. The People's Procuratorate of Minhang District requested that the Primary People's Court of Minhang District should punish Bian Fei in accordance with the provisions of item (1) of Article 225 and Articles 231, 30, and 31 of the Criminal Law of the People's Republic of China. 起诉书指控:2015年7月起,被告人卞飞在经营上海辉海电子设备有限公司(以下简称辉海公司)过程中,生产型号为SE-F1、SE-F2、SE-F3系列生物能量仪,并由上海明珠医疗科技发展有限公司(以下简称明珠公司)进行销售,累计生产、销售SE系列生物能量仪182台,合计金额人民币924 270元。经国家食品药品监督管理总局(以下简称食药总局)复函,认定该SE系列生物能量仪属于第二类医疗器械。国家红外及工业电热产品质量监督检验中心武汉产品质量监督检验所《检验报告》分别对SE-生物能量仪及哈尔滨全科治疗仪的相对辐射能谱(红外辐射波长范围)进行了检验。2016年12月,行政执法部门查扣涉案SE系列生物能量仪127台,价值人民币581 740元。卞飞违反国家规定,未经许可经营法律、行政法规规定的限制买卖的物品,扰乱市场秩序,情节严重,其行为已构成非法经营罪。提请法院依照《中华人民共和国刑法》第二百二十五条第(一)项、第二百三十一条、第三十条、第三十一条之规定,对卞飞予以判处。
...... 被告人卞飞辩称:涉案产品系合格的家用电器产品,并非医疗器械,其系合法经营,不构成非法经营犯罪。
 辩护人提出辩护意见如下:北京市第一中级人民法院(2017)京行初502号《行政裁定书》认为复函实质是被告与上海市食品药品监督管理局(以下简称上海食药局)就前述具体法律使用问题的意见交流,并未确定新的权利义务关系,对闵行市场局如何就原告生产SE-生物能量仪产品的行为进行认定不产生法律拘束力。复函并非认定涉案SE-生物能量仪系二类医疗器械的法律依据。辉海公司仅在普通家用电器渠道销售涉案产品,没有进入任何医疗机构,没有相关医疗器械的宣传。医疗器械属于经审查后即可经营的物品,并非国家专营专卖或者限制买卖需要国家特许经营的物品,套用非法经营罪显然不当,请求对被告人卞飞宣告无罪。
 上海市闵行区人民法院一审查明:
 被告人卞飞系辉海公司、明珠公司的法定代表人。辉海公司的经营范围包括电子设备、电子产品的销售、电子保健仪器(除医疗器械)的组装、销售;明珠公司的经营范围包括医疗器材、医疗保健、生物制品等。2015年7月起,辉海公司开始生产型号为SE-F1、SE-F2、SE-F3系列生物能量仪,由明珠公司进行销售。2016年3月,上海市闵行区市场监督管理局(以下简称闵行市场局)就该产品是否作为医疗器械产品管理,如作为医疗器械管理,应按几类医疗器械进行注册,上述产品是否取得医疗器械产品注册证的情况向上海食药局请示,并递交了SE-生物能量仪包装及产品照片、生物能量仪使用参考书和合格证原件。上海食药局就此向食药总局请示前述产品是否应按二类医疗器械管理,食药总局针对上海食药局的请示回复函称:该产品预期目的符合《医疗器械管理条例》(国务院令650号)第七十六条要求,依据《医疗器械分类规则》(食品药品监管总局令第15号),应作为第二类医疗器械管理。
 2016年12月,闵行市场局于现场执法中,在闵行区春中路28弄6号辉海公司的仓库内及明珠公司的相关销售点查扣涉案SE系列生物能量仪共计127台,总价值人民币581 740元。
 经上海沪港金茂会计师事务所有限公司鉴定,至案发,辉海公司、明珠公司累计生产、销售SE系列生物能量仪182台,合计金额人民币924270元。
 ......



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