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基于国际比较的我国兽医器械立法构建研究OA

Research on the Construction of China's Veterinary Device Legislation Based on International

中文摘要英文摘要

通过比较研究几个畜牧业发达国家的兽医器械监管体系,系统分析其在法律框架、风险分类、监管制度及机构设置等方面的异同.研究表明,以"基于风险分类的全生命周期监管"为核心构建法律体系,是国际普遍采用且有效的通行模式[1].在此基础上,结合我国兽医器械行业现状,从科学分类、机构协同、全程监管、标准接轨、行业自律等五个方面提出具体的技术建议,并逐步构建"法律-法规-指南"三级监管体系,以期填补当前监管空白,促进我国兽医器械行业高质量发展.

This paper systematically analyzes the similarities and differences in the legal frameworks,risk classification systems,regulatory mechanisms,and institutional arrangements of veterinary device regulatory systems in several developed livestock-producing countries through comparative research.The study indicates that building a legal system centered on"risk-based classification and full-lifecycle regulation"represents an internationally recognized and effective model[1].Based on this,and considering the current state of China's veterinary device industry,specific technical recommendations are proposed across five dimensions:scientific classification,institutional coordination,end-to-end oversight,standard alignment,and industry self-regulation.A three-tier regulatory framework comprising"laws-regulations-guidelines"will be progressively established to address existing regulatory gaps and promote high-quality development within China's veterinary device sector.

于遵波;张晶声;金闻名;杨晶;张志轩;周贺;李建波

中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081中国兽医药品监察所(农业农村部兽药评审中心),北京 100081

农业科技

兽医器械立法监管国际比较风险分类全生命周期管理监管体系

veterinary deviceslegislative regulationinternational comparisonrisk-based classificationFull-lifecycle regulationregulatory system

《中国兽药杂志》 2026 (3)

66-73,8

中国兽医药品监察所兽药行业公益性重点专项"兽医器械立法研究"(GY202409)

10.11751/ISSN.1002-1280.2026.3.10

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