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

移动健康产品的预期用途界定是一个关于产业监管的关键问题,因为产品的预期用途决定了相应食品药品监管部门是否对其行使监管权力。一般来说,食品药品监管部门监管职能的第一步是判断该产品是否属于医疗器械,即产品的预期用途是否属于诊断、预防、监护、治疗疾病。许多移动健康产品目前是为了解决一般的健康和保健问题,然而保健、医学诊断或治疗的分界线却不明确。本文介绍了国内外的一些初步的监管思路,随着该领域产业的蓬勃发展和新的业态出现,思路必将会逐步明晰。

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 frst 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.