Legal analysis: medical devices in accordance with the degree of risk to implement the classification and management, can be divided into three categories: the first category refers to the routine management is sufficient to ensure the safety and effectiveness of medical devices, such as surgical instruments, stethoscopes, gua sha boards, etc.; the second category refers to the safety and effectiveness of the medical devices should be controlled, such as sphygmomanometers, thermometers, skin staples, contraceptive caps, etc.; the third category is implanted in the human body to support, maintain life with potential danger to the human body must be strictly controlled for its safety and effectiveness. refers to the implantation of the human body, used to support, maintain life, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices, such as pacemakers, implantable artificial organs, single-use infusion sets, etc..
Legal basis: "Rules for the Classification of Medical Devices" Article 2 Medical devices are: instruments, equipment, appliances, materials or other items used in the human body, alone or in combination, including the required software. The purpose of its use is:
(a) prevention, diagnosis, treatment, monitoring or alleviation of disease.
(ii) Diagnosis, treatment, guardianship, mitigation or compensation for injury or disability.
(iii) The study, substitution, or regulation of anatomical or physiological processes.
(iv) Pregnancy control.
The effects of its use on the human body surface and in the body are not obtained by pharmacological, immunological or metabolic means, but may have the participation of these means and play an auxiliary role.