中国动物检疫2026，Vol.43Issue(8)：53-58,6.DOI:10.3969/j.issn.1005-944X.2026.08.008
美国兽医器械监管体系分析及启示
Analysis of the Regulatory System for Veterinary Devices in the United States and Its Implications
摘要
Abstract
In order to comprehensively understand the framework and functioning of the regulatory system for veterinary devices in the United States,the legal framework,classification,institutional structure,and operational mechanism of the system were systematically reviewed.The results showed that veterinary devices in the United States were governed by the Federal Food,Drug,and Cosmetic Act,under which they were incorporated into the common regulatory framework for medical devices and managed through a risk-based classification system.An end-to-end regulatory mechanism was established,covering premarket notification,premarket approval,quality system regulation,adverse event monitoring,and product recall.In addition to safeguarding the safety and effectiveness of veterinary devices,the system accommodated both animal health protection and industrial innovation.Its regulatory approach,characterized by risk-based classification and end-to-end control,provided references for relevant legislation and regulatory practices in China.关键词
美国/兽医器械/监管体系/风险分类/立法Key words
the United States/veterinary device/regulatory system/risk classification/legislation分类
农业科技引用本文复制引用
于遵波..美国兽医器械监管体系分析及启示[J].中国动物检疫,2026,43(8):53-58,6.基金项目
中国兽医药品监察所第三批"兽药行业公益性重点专项"(GY202409) （GY202409）
