摘要
分析目前人类辅助生殖技术用医疗器械的法规现状和产业发展趋势,为相关法律法规和标准体系的建立和完善提供参考信息。详述国内外人类辅助生殖技术用医疗器械产业发展历史及现状;概述不同国家的监管情况,相关法规要求和现行标准体系;简要介绍相关法规和标准中对风险控制的通用技术要求,为相关生产企业、研究人员,以及该类产品的注册检验和科学监管提供综合的参考信息。
The current regulations and industry development trend of medical devices for human assisted reproductive technology（ART）were overviewed to provide the references for establishing the relevant regulations and standard system. The current situation and history of industrial development of medical devices for human ART in domestic and abroad were surveyed in detail. The relevant statutory requirements, regulations and current standard systems were collected from several countries. The potential risks for these special medical devices were analyzed and the general technical requirements for controlling the risks were discussed. This paper will provide comprehensive information not only for the manufacturers and researchers ,but also for registration and supervision of these kind products.
出处
《生殖医学杂志》
CAS
2015年第7期591-596,共6页
Journal of Reproductive Medicine
关键词
人类辅助生殖技术
医疗器械
标准
法规
监管
Assisted reproductive technology
Medical device
Standard
Regulation
Supervision
