中国医疗设备2017，Vol.32Issue(6)：6-8,19,4.DOI:10.3969/j.issn.1674-1633.2017.06.002
基于预期用途的移动健康产品监管分类要求
Regulatory Requirements for Mobile Health Products Based on Intending Use
摘要
Abstract
The intending use of mobile health products is a key issue in the regulation of the medical device industry, since the intending use of the mobile health product determines whether the food and drug regulatory authorities take regulatory actions. In general, the first step for the food and drug regulatory authority is to understand whether the product belongs to the medical device, that is, whether the intending use of the product belongs to the diagnosis, prevention, monitoring and treatment of disease. Many mobile health products are currently designed to address general health and healthcare issues, but the boundaries of healthcare, medical diagnosis or treatment are not clear. This article described some of the early stage regulatory ideas at home and abroad. With the rapid development of the industry and the emergence of new formats, the regulatory policy will gradually develop.关键词
移动健康产品/移动医疗器械/用途界定/预期用途/医学诊断Key words
mobile health products/mobile medical devices/define of use/intended use/medical diagnosis分类
信息技术与安全科学引用本文复制引用
李澍,王浩,罗维娜,王晨希,任海萍..基于预期用途的移动健康产品监管分类要求[J].中国医疗设备,2017,32(6):6-8,19,4.基金项目
国家重点研发计划(2016YFC0103202) （2016YFC0103202）
国家体育总局科研课题(2015B100). （2015B100）
