How to judge whether a product belongs to a medical device product? Is there any channel for inquiry?

Products that meet the definition in Article 3 of the Regulations on the Supervision and Administration of Medical Devices are medical devices.

The term "medical devices" as mentioned in Article 3 of the Regulations refers to instruments, equipment, appliances, materials or other articles used in human body alone or in combination, including required software; Its effects on human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; Its purpose is to achieve the following expected purposes:

(1) Prevention, diagnosis, treatment, monitoring and mitigation of diseases;

(2) Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability;

(3) research, substitution and adjustment of anatomical or physiological processes;

(4) Pregnancy control.

Therefore, whether it is a medical device or not should be judged mainly by the expected use of the product it promotes. If the same product claims different intended uses, there may be different judgment results. Express the idea of the expected use of the product to the consumers in the market through the text contents such as product specifications, packaging, labels and promotional materials.