摘要
日本兽医器械监管制度以风险分级为基础,涵盖产品注册、生产许可、销售管理等全流程要素,其核心制度包括:基于风险等级(一般、受控、高度受控)的产品分类管理、差异化审批(注册/备案)制度、本土与境外生产企业分级许可、制造销售许可制(MAH)、销售环节的许可/备案分级管理.日本通过农林水产省主导、兽医事务审议会技术支撑的协同机制,结合动态更新的器械目录和灵活的创新产品审批程序,实现了监管效能与产业创新的平衡.该体系为我国兽医器械立法提供了可借鉴的经验,尤其在风险分类、主体责任界定及监管灵活性方面具有参考价值.
Abstract
The regulation system for veterinary instruments in Japan is based on risk grading,covering the entire process including product registration,manufacturing licensing and distribution management,with core components as follows:risk-based(general,controlled and highly controlled)product classification and management,differential approval(registration/filing)system,hierarchical licensing for domestic and foreign manufacturers,marketing authorization holder(MAH)system and hierarchical licensing and filling system for sales process.The regulation performance and industrial innovation were balanced in Japan through a collaborative mechanism led by the Ministry of Agriculture,Forestry and Fisheries(MAFF),technically supported by the Veterinary Affairs Council(VAC),and in combination with the dynamically updated catalogs of instruments and the flexible approval procedures for innovative products.Valuable experiences therein were referenced by the legislation on veterinary instruments in China,particularly in risk classification,definition of entities' duties and flexibility of regulation.
维普
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