Article 1 To regulate the classification of medical devices, according to the "Supervision and Administration of Medical Devices Regulations", the development of these rules.
Article II medical devices are: instruments, equipment, apparatus, materials or other items used in the human body alone or in combination, including the required software. The purpose of its use is.
　　(A) the prevention, diagnosis, treatment, monitoring or mitigation of disease.
　　(B) injury or disability diagnosis, treatment, monitoring, mitigation or compensation.
　　(iii) The study, replacement or regulation of anatomical or physiological processes.
　　(iv) Pregnancy control.
　　Its use on the human body surface and in vivo effects are not obtained by means of pharmacology, immunology or metabolism, but may have these means involved and play a supporting role.
Article III The rules are used to guide the development of the "Medical Device Classification Catalog" and determine the new product registration categories.
Article IV to determine the classification of medical devices, should be based on the structural characteristics of medical devices, medical devices in the form of medical device use and medical device use of the three aspects of the situation for a comprehensive determination.
　　Medical device classification of the specific determination can be based on the "Medical Device Classification Determination Table" (see Annex).
Article V of the medical device classification determination based on.
　　(A) the structural characteristics of medical devices
　　The structural characteristics of medical devices are divided into: active medical devices and passive medical devices.
　　(B) the use of medical devices form
　　According to the different intended purposes, medical devices are classified into certain forms of use. Among them.
　　1. The use form of passive devices are: drug delivery and preservation devices; changing blood, body fluids devices; medical dressings; surgical devices; reuse surgical devices; disposable sterile devices; implantable devices; contraceptive and family planning devices; sterilization and cleaning devices; nursing devices, in vitro diagnostic reagents, other passive contact or passive auxiliary devices, etc.
　　2. The use of active devices in the form of: energy therapy devices; diagnostic and monitoring devices; delivery of body fluids devices; ionizing radiation devices; laboratory instruments and equipment, medical sterilization equipment; other active devices or active auxiliary equipment, etc.
　　(C) the use of medical devices state
　　According to the use of the possibility of damage to the human body on the impact of medical effects, the use of medical devices can be divided into contact or access to the human body devices and non-contact human devices, specifically can be divided into.
　　1 contact or into the human body devices
　　(1) the use of time frame is divided into: temporary use; short-term use; long-term use.
　　(2) contact with the human body is divided into: skin or cavity; trauma or body tissue; blood circulation system or central nervous system.
　　(3) the degree of damage caused by the loss of control of active devices are divided into: minor damage; injury; serious injury.
　　2. Non-contact human instruments
　　The impact on medical effects, the degree of impact is divided into: basically no impact; have indirect impact; have important impact.
Article VI of the implementation of the classification of medical devices to determine the principles
　　(A) the implementation of the classification of medical devices, should be based on the classification determination table.
　　(B) the classification of medical devices to determine the main purpose and role of its intended use. The same product if the purpose of use and role of different ways, classification should be determined separately.
　　(C) the joint use of medical devices with other medical devices, should be classified separately; medical device accessories classification should be separated from its supporting host, according to the case of the accessories are classified separately.
　　(D) the role of several parts of the human body medical devices, according to the form of high-risk use, the use of state classification.
　　(E) control the function of the medical device software and the medical device in accordance with the same category for classification.
　　(F) If a medical device can be applied to two classifications, the highest classification should be taken.
　　(G) monitoring or influence the main function of the medical device, the classification of the product and the medical device being monitored and affected by the same classification.
　　(H) the State Drug Administration according to the needs of the work, the need for special supervision and management of medical devices can adjust their classification.
Article VII of the State Drug Administration in charge of the classification of medical devices. Based on the "Medical Device Classification Catalog" can not determine the classification of medical devices, by the provincial drug supervision and management departments according to "Medical Device Classification Rules" for pre-classification, and reported to the State Drug Administration for approval.
Article VIII of the rules of the following terms mean
　　(A) the intended purpose: refers to the product description, labeling or promotional materials set forth, the use of medical devices should be achieved by the role.
　　(B) the risk: the possibility of the risk of injury to the human body and the severity of the injury.
　　(C) the period of use.
　　1. Temporary: the expected continuous use of the device within 24 hours.
　　2. short-term: the expected continuous use of the device within 24 hours or more than 30 days.
　　3. long-term: the expected continuous use of the device for more than 30 days.
　　4. continuous use time: the device according to the intended purpose, without interruption of the actual time of action.
　　(D) the use of parts and devices.
　　1 non-contact devices: devices that do not directly or indirectly contact the patient.
　　2 surface contact devices: including devices in contact with the following parts
　　(1) skin: devices that only contact the surface of undamaged skin.
　　(2) mucous membranes: instruments that come in contact with mucous membranes
　　(3) injury surface: instruments in contact with the wound or other injury body surface.
　　(3) surgical invasive instruments: with the help of surgical procedures, all or part of the instrument through the body surface invasion of the body, contact including the following parts of the device.
　　(1) vascular: invasion of blood vessels in contact with a point on the blood path; as a pipeline to the vascular system input devices.
　　(2) Tissue/bone/dentin: instruments and materials that invade the tissue, bone and pulp/dentin systems.
　　(3) blood circulation: instruments that contact the blood circulation system.
　　(E) Implantable instruments: Any instrument that enters the body or natural cavity in whole or in part with the aid of surgical procedures; remains in the body for a long period of time after the surgical procedure, or these instruments remain partially in the body for at least 30 days, these instruments are considered to be implanted instruments.
　　(F) Active devices: Any medical device that relies on electrical or other energy sources rather than energy generated directly by the body or gravity to perform its function.
　　(vii) reuse surgical instruments: refers to the instruments used in the surgery of the Department of surgery for cutting, cutting, drilling, sawing, grasping, scraping, clamping, pumping, clamping or similar surgical procedures, not connected to any active instruments, through certain processing can be reused instruments.
　　(H) Central circulatory system: refers to the pulmonary artery, aorta, coronary artery, strong artery, cerebral artery, cardiac vein, superior major vena cava, inferior major vena cava in human blood circulation.
　　(Ix) central nervous system: refers to the brain, meninges, spinal cord.
Article IX of these rules by the State Drug Administration is responsible for the interpretation.
Article X of these rules from April 10, 2000 onwards.