What is a medical device, and what are you talking about?

Medical devices refer to instruments, equipment, appliances, materials or other articles used on the human body alone or in combination, including required software; Its effects on the human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate in and play a certain auxiliary role; Its use is intended to achieve the following intended purposes: (1) the prevention, diagnosis, monitoring, and alleviation of diseases; (2) Diagnosis, monitoring, mitigation, or compensation for injuries or disabilities; (3) Research, substitution, or regulation of anatomical or physiological processes; (4) Pregnancy control.

Medical devices refer to instruments, equipment, appliances, materials or other articles used on the human body alone or in combination, including required software; Its effects on the human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate in and play a certain auxiliary role; Its use is intended to achieve the following intended purposes: (1) the prevention, diagnosis, monitoring, and alleviation of diseases; (2) Diagnosis, monitoring, mitigation, or compensation for injuries or disabilities; (3) Research, substitution, or regulation of anatomical or physiological processes; (4) Pregnancy control.

Medical devices in this paragraph are divided into three categories.

Category I. It is enough to ensure the safety and effectiveness of medical devices through routine management.

Category II. Medical devices whose safety and effectiveness should be controlled.

Category III. It is used to implant in the human body to support and maintain life; Medical devices that are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness.

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Medical equipment is the instrument that participates in medical assistance in addition to all living organisms.

What is a medical deviceA medical device is an instrument, device, appliance, material, or other item used on the human body, either alone or in combination, including required software. The purpose of the use of these articles is to diagnose, monitor, alleviate or compensate for human diseases, disabilities, as well as the study of pregnancy control, anatomical or physiological processes, etc., and their effects on the human body are not obtained by pharmacological, immunological or metabolic means, but may involve these means and play a certain auxiliary role.

Medical Device Classification CatalogAccording to the Regulations on the Administration of Medical Devices, China divides medical devices into three categories:

Category 1: Medical devices that are sufficient to ensure their safety and effectiveness through routine management, such as ordinary surgical scalpels, scissors, dressings, etc.

Category II: Medical devices whose safety and effectiveness should be controlled, such as medical suture needles.

The third category: medical devices implanted in the human body, used to support and maintain life, potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled, such as various syringes, infusion sets, pacemakers, artificial heart valves, artificial joints, vascular stents, etc.

Medical Devices:

Definition of medical devices: medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are directly or indirectly used in the human body, including the required computer software;Its effect is mainly obtained by physical means, not by pharmacological, immunological or metabolic means, or although these methods are involved, they only play an auxiliary role;Its purpose is:

a) The disease is diagnosed, prevented, monitored, or mitigated;

2) Diagnosis, monitoring, mitigation, or functional compensation of the injury;

3) Testing, substitution, regulation or support of physiological structures or physiological processes;

4) Support or maintenance of life;

e) Pregnancy control;

6) To provide information for medical or diagnostic purposes by examining samples from the human body.

The definition of medical devices in Chapter VIII of the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the People's Republic of China) refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are directly or indirectly used in the human body, including the required computer software.

The use of medical devices is intended to achieve the following intended purposes:

1. Prevention, diagnosis, monitoring, and alleviation of diseases.

2. Diagnosis, monitoring, mitigation and compensation for injury or disability.

3. Research, substitution, modulation or support of anatomical or physiological processes.

4. Support or sustain life.

5 Pregnancy control.

6 To provide information for medical or diagnostic purposes by examining samples from the human body.