is hereby issued. Since April 10, 2000 shall come into force.
Director: Zheng Xiaoyu
April 5, 2000
Medical Device Classification Rules
Article 1 In order to standardize the classification of medical devices, according to the "Regulations for the Supervision and Management of Medical Devices", the formulation of these rules.
The second medical device means: a single or a combination of instruments, equipment, apparatus, materials or other
items used in the human body, 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 be assisted by the involvement of such means.
Article 3 These rules are used to guide the development of the Classification List of Medical Devices and to determine the new product registration categories.
Article IV to determine the classification of medical devices, medical devices should be based on the structural characteristics of medical devices, medical devices used in the form of medical devices and medical devices
The use of the three aspects of the situation to make a comprehensive judgment.
The classification of medical devices can be based on the specific determination of the "Medical Device Classification Table" (see Annex).
Article V Classification of medical devices based on the determination of
(a) the structural characteristics of medical devices
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 the different intended purposes, medical devices will be categorized into certain forms of use. Among them:
1. The use of passive devices in the form of: drug delivery and preservation devices; change blood, body fluids devices; dressings; surgical
surgical instruments; reuse surgical instruments; disposable sterile devices; implantable devices; contraceptives and family planning devices; disinfecting and cleaning
cleaning devices; nursing devices, in vitro diagnostic reagents, other passive contact or passive auxiliary devices etc.
2. Active devices are used in the form of energy therapy devices; diagnostic and monitoring devices; devices for the delivery of body fluids; ionizing radiation
devices; laboratory instruments and equipment, medical disinfection equipment; other active devices or active auxiliary equipment.
(C) the use of medical devices
Based on the use of the possibility of damage to the human body, the impact on the medical effect, the use of medical devices can be divided into
contact or into the human body and non-contact human body devices, can be divided into:
1. contact or into the human body
(1) the time limit for the use of temporary use; short-term use; long-term use Use; short-term use; long-term use.
(2) contact with the human body is divided into: skin or cavity; trauma or body tissues; circulatory system or central nervous system
system.
(3) The degree of damage caused by the loss of control of the active device is categorized as: minor injury; injury; serious injury.
2. Non-contact with the human body device
The effect on the medical effect, the degree of its classification: basically does not affect; have an indirect effect; have an important effect.
Article VI of the implementation of medical device classification principles
(a) the implementation of the classification of medical devices, should be based on the classification table.
(2) medical device classification judgment is mainly based on its intended purpose of use and function. The same product if the use of the purpose and mode of action is different, the classification should be determined separately.
(C) and other medical devices used in conjunction with medical devices, should be classified separately; medical device accessories classification
should be separated from its supporting main body, according to the situation of the accessories are classified separately.
(D) the role of several parts of the body of 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 according to the same category for classification.
(F) If a medical device can be applied to two classifications, 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.
(h) State Drug Administration in accordance with the needs of the work, the need for specialized supervision and management of medical devices can be adjusted
Adjustment of its classification.
Article VII of the State Drug Administration in charge of medical device classification. According to the "Classification of Medical Devices Catalog" does not
can 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 the pre-subdivision
class, 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 contained in the use of medical devices should be obtained
Use.
(b) risk: the possibility of causing harm to the human body and the severity of the risk of 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 and less than 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, without interruption. The period of time during which the device is actually used for its intended purpose without interruption.
(D) the use of parts and devices:
1. non-contact devices: devices that do not come into contact with the patient directly or indirectly;
2. surface-contact devices: including devices that come into contact with:
(1) the skin: devices that come into contact with the undamaged surface of the skin only;
(2) mucous membranes: devices that come into contact with the mucous membrane;
(3) damaged surfaces: devices that come into contact with the mucous membrane only;
(5) the surface of the skin; and (6) the surface of the skin. 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, instruments that are wholly or partially invasive through the surface of the body, in contact with the following
parts of the body:
(1) vascular: invasive blood vessels in contact with the bloodstream at a certain point; as a conduit to the vascular system into the instrument;
(2) tissue / bone / dental: invasive tissues, bone and pulp / dental system of instruments and materials;
(3) injury surface: contact with a wound or other injury to the surface of the body. system;
(3) Circulation: instruments that contact the circulatory system.
(5) Implanted device: Any device that is introduced into the human body or a natural cavity, in whole or in part, by means of a surgical procedure; that remains in the body for a prolonged period of time after the completion of the surgical procedure; or that remains partially in the body for a period of at least 30 days is considered to be an implanted device.
(f) 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 instruments: refers to instruments used in surgery to cut, slash, drill, saw, grasp, scrape, pincer,
extraction, clamping, or similar surgical procedures, not connected to any active instruments, through certain processing can be reused instruments.
(viii) Central circulatory system: the pulmonary artery, the aorta, the coronary arteries, the carotid arteries, the cerebral
arteries, the cardiac veins, the superior vena cava, and the inferior vena cava of the human blood circulation.
(ix) Central nervous system: the brain, meninges, spinal cord.
Article IX of these rules by the State Drug Administration is responsible for the interpretation.
Article X. These rules from April 10, 2000 shall be implemented.
These rules shall be implemented as of April 10, 2000.