摘要
Abstract
Objective To provide reference for the registration application and technical evaluation of personalized dental implant guide plate.Method The study summarizes the structural composition,expected use,working principle,materials,product technical requirements,biocompatibility,manufacturing process,and product manual of personalized dental implant guide plates by organizing and analyzing relevant regulations,standards,similar products,journal literature,and combining daily review work and research.Based on product risk,it explores the key points of technical review for registration.Results and conclusion Summarize the key requirements for each item.Based on this,it is recommended that registration applicants conduct in-depth safety studies during the design and development process based on product risk profile,perform comprehensive effectiveness evaluation,with particular attention to common registration issues,in order to improve the quality and efficiency of product registration and application,and help promote industrial development.关键词
个性化/牙科种植导板/风险分析/注册申报/技术审评/要点分析Key words
personalization/dental implant guide plate/risk analysis/registration declaration/technical review/main points analysis分类
医药卫生
