(a) disease prevention, diagnosis, treatment, monitoring or mitigation.
(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.
Their use on the human body surface and in the body is not obtained by pharmacological, immunological or metabolic means, but these means may be involved and play a supporting role. Article III These 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 used in the form of medical devices and medical devices used in the situation of three aspects of a comprehensive determination.
The specific determination of medical device classification can be based on the "Medical Device Classification Table" (see Appendix). Article V classification of medical devices to determine the basis:
(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 form of use of medical devices
Based on different intended purposes, medical devices are categorized into certain forms of use. Among them:
1. The use of passive devices in the form of: drug delivery and preservation devices; change the blood, body fluids devices; dressings; surgical instruments; reuse surgical instruments; disposable sterile devices; implantable devices; contraception and family planning devices; disinfecting 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 monitoring devices; delivery of body fluids devices; ionizing radiation devices; laboratory instruments and equipment, medical disinfection equipment; other active devices or active auxiliary equipment.
(C) the use of medical devices
According to the use of the human body to produce the possibility of injury to the medical effect of the medical device can be divided into contact or into the human body devices and non-contact human body devices, can be divided into:
1. contact or into the human body devices
(1) the time limit for use 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 the active device is divided into: minor injury; injury; serious injury.
2. Non-contact with the human body devices
The impact on the medical effect, the degree of which is divided into: basically does not affect; have an indirect impact; have an important impact. Article VI implementation of medical device classification of judgment principles
(a) the implementation of medical device classification, should be based on the classification of judgment table.
(2) medical device classification judgment is mainly based on its intended purpose of use and role. The same product if the purpose of use and role of different ways, the classification should be determined separately.
(C) and other medical devices used in conjunction with other medical devices, should be classified separately; medical devices should be separated from the classification of accessories and its supporting host, according to the annexes to be classified separately.
(D) role in several parts of the human body, medical devices, according to the high risk of the form of use, the use of state classification.
(E) control the function of the medical device software and the medical device is classified according to the same category.
(vi) If two classifications can be applied to a medical device, the highest classification should be taken.
(vii) Products that monitor or influence the primary function of a medical device are classified in the same category as the monitored and influenced device.
(viii) State Drug Administration in accordance with the needs of the work, the need for specialized supervision and management of medical devices can be adjusted to its classification. Article VII of the State Drug Administration in charge of medical device classification. According to the "Classification of Medical Devices Catalog" can not determine the classification of medical devices, by the provincial drug supervision and management departments in accordance with the "Rules for the Classification of Medical Devices" for pre-categorization, and reported to the State Drug Administration for approval. Article VIII of these rules the meaning of the following terms are:
(a) the intended purpose: refers to the product description, labeling or promotional materials contained in the use of medical devices should be achieved.
(b) risk: the possibility of the occurrence of the risk of injury to the human body and the severity of the injury.
(C) the duration of use:
1. temporary: the device is expected to be used continuously for less than 24 hours;
2. short-term: the device is expected to be used continuously for more than 24 hours within 30 days;
3. long-term: the device is expected to be used continuously for more than 30 days;
4. continuous use of the time: the device according to the intended purpose, the time during which the effect actually occurs without interruption.
(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 the following parts of the contact with the device;
(1) skin: only contact with the surface of the skin is undamaged;
(2) mucous membranes: mucous membranes in contact with the device;
(3) damaged surfaces: only contact with the surface of the skin;
(4) the use of the device: the use of the device in accordance with the intended purpose of the actual effect of the time without interruption. p>(3) Injured surfaces: instruments that come into contact with wounds or other injured body surfaces.
3. Surgical invasive instruments: with the aid of surgical procedures, the instrument all or part of the body through the body surface invasion of the body, the contact includes the following parts of the instrument:
(1) blood vessels: invasion of blood vessels in contact with the blood path at a certain point; as a conduit to the vascular system into the instrument;
(2) tissues / bone / dental: invasive tissues, bone and dental pulp / dental system of instruments and materials;
(3) Circulation: instruments that contact the circulatory system.
(5) Implanted instruments: any instruments that are introduced into the human body or natural cavities, in whole or in part, with the aid of a surgical procedure; that remain in the body for a prolonged period of time after the surgical procedure has been completed, or that remain partially in the body for at least 30 days, are considered implanted instruments.
(vi) Active device: any medical device that relies on electrical or other energy sources other than those generated directly by the human body or gravity to perform its function.
(vii) Reusable Surgical Instrument: an instrument that is used to perform incision, cutting, drilling, sawing, grasping, scraping, pincer, extraction, clamping, or similar surgical procedures in the Department of Surgery, and that is not connected to any active instrument, and that can be reused through certain processing.
(viii) Central circulatory system: the pulmonary artery, aorta, coronary arteries, power arteries, cerebral arteries, cardiac veins, superior vena cava, and inferior vena cava of the human blood circulation.
(ix) Central nervous system: refers to the brain, meninges, spinal cord.