Abstract：The edge products of medical devices referred to herein involve the collection and monitoring of human physiological
data, the regulation of physiological functions, and the relief of disease symptoms, which are related to the health of the public.
With the growth of product types and market size, the control of their safety and effectiveness is an urgent task faced by regulatory
authorities. The regulatory authorities need to first clarify its management attributes in order to determine reasonable regulatory
policies. At present, although there are documents such as The Classification Catalogue of Medical Devices which can be used as
the basis for the definition of management attributes of some edge products, it still cannot cover all such products. There are still
issues with defining product management attributes in regulatory work, and even regulatory loopholes that have caused confusion for
manufacturers and users. This paper first clarifies three situations of medical device edge products from regulatory perspective, and
analyzes the current international and domestic relevant regulations, documents and regulatory policies. Combined with the current
product characteristics, the key elements such as working mechanism, structural design, application scenarios and population were
analyzed in detail, and the conditions required for various products to be used as medical device management are clarified. This paper
puts forward technical suggestions for the definition of management attributes and provides reference for the regulatory authorities
and industry.
戎善奎，许慧雯，赵佳，余新华. 医疗器械边缘产品管理属性探讨[J]. 中国医疗设备, 2023, 38(8): 154-160.
RONG Shankui, XU Huiwen, ZHAO Jia, YU Xinhua. Discussion on Management Attribute About Edge Products of Medical Devices. China Medical Devices, 2023, 38(8): 154-160.
