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.
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.
LI Shu, WANG Hao, LUO Wei-na,
WANG Chen-xi, REN Hai-ping. Regulatory Requirements for Mobile Health Products Based on Intending
Use. China Medical Devices, 2017, 32(6): 6-8.
