Are medical science model a medical device?

Many customers do not know the medical science model industry well, so they do not have an answer to whether a medical model is a medical device. Therefore, when ordering a medical model from Zhineng Medical Model, they require us to provide documents such as a medical device production license. However, after detailed explanations by relevant colleagues, these customers suddenly realized that the medical model is not a medical device! Do you also have such an illusion?

In fact, medical science models are really not medical devices, because, according to the "Regulations on the Supervision and Administration of Medical Devices" promulgated by the State Council, medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other directly or indirectly used in the human body. Similar or related items, including required computer software. The purpose of a medical device is to:

(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases; diagnosis, monitoring, treatment, alleviation or functional compensation of injuries;

(2) Inspection, replacement, regulation or support of physiological structure or physiological process; life support or maintenance; pregnancy control;

(3) To provide information for medical or diagnostic purposes by examining samples from the human body. The main purpose of the medical model is to use it as a teaching demonstration tool for simulation teaching and practice in medical colleges and hospitals and other medical units during related medical teaching and training. So in short, medical models belong to teaching aids, not medical equipment that most people mistakenly think.

Through the interpretation of the above knowledgeable medical science model, have you also gained a new understanding of the product attributes of the medical model?