中国兽药杂志2026，Vol.60Issue(3)：66-73,8.DOI:10.11751/ISSN.1002-1280.2026.3.10
基于国际比较的我国兽医器械立法构建研究
Research on the Construction of China's Veterinary Device Legislation Based on International
摘要
Abstract
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.关键词
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Key words
veterinary devices/legislative regulation/international comparison/risk-based classification/Full-lifecycle regulation/regulatory system分类
农业科技引用本文复制引用
于遵波,张晶声,金闻名,杨晶,张志轩,周贺,李建波..基于国际比较的我国兽医器械立法构建研究[J].中国兽药杂志,2026,60(3):66-73,8.基金项目
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) （GY202409）
