Article 1? In order to standardize the classification of medical devices, according to the "Regulations for the Supervision and Administration of Medical Devices", the formulation of these rules.
Article 2? Medical device refers to:
Instruments, equipment, apparatus, materials or other
items used in the human body, either alone or in combination, including the required software. The purposes of its use are:
(i) 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 these
involved and play a supporting role.
Rule 3? These rules are used to guide the development of the Medical Device Classification Catalog and to identify new product registration categories.
Article 4? 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
Medical devices used in the situation of the three aspects of a comprehensive determination.
The specific determination of the classification of medical devices can be based on the Medical Device Classification Determination Table (see Annex).
Article V? Classification of medical devices determined on the basis of
(a) the structural characteristics of medical devices
Structural characteristics of medical devices are divided into: active medical devices and passive medical devices.
(ii)Forms of use of medical devices
Medical devices are categorized into certain forms of use according to different intended purposes. Among them:
1. The use of passive devices in the form of: drug delivery and preservation devices; change the blood, body fluids devices; medical dressings; surgical
Surgical instruments; reuse surgical instruments; disposable sterile devices; implantable devices; contraception and family planning devices; disinfection and cleaning
Cleaning devices; nursing instruments, in vitro diagnostic reagents, other passive contact or passive auxiliary device 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 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 of medical effects, the use of medical devices can be divided into
Contact or access to the human body and non-contact human body devices, can be divided into:
1. Contact or access to the human body
(1) the use of the time limit is divided into: temporary Use; short-term use; long-term use.
(2) the part of 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 divided into: minor injury; injury; serious injury.
2. Non-contact with the human body device
The effect on the medical effect of the degree of: basically does not affect; have an indirect effect; have an important effect.
Article VI? Implementation of the principle of determination of medical device classification
(a) Implementation of medical device classification, should be based on the classification of determination 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 the role of different ways, the classification should be determined separately.
(C) and other medical devices used in conjunction with the medical device should be classified separately; medical device accessory classification
should be separated from its supporting host, according to the accessory is 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.
(v) The software that controls the function of the medical device is classified according to the same category as the medical device.
(vi) If two classifications can be applied to a medical device, the highest classification shall 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
their classification.
Article VII? State Drug Administration in charge of the classification of medical devices. Based on the "Medical Device Classification 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
classification, and reported to the State Drug Administration for approval.
Article 8? The meaning of the following terms of these rules:
(a) the intended purpose: refers to the product description, labeling or promotional materials contained in the use of medical devices should be obtained
use.
(ii) risk: the likelihood of the occurrence of the risk of injury to the human body and the severity of the injury.
(iii) Duration of use:
1. Temporary: the device is expected to be used continuously for a period of less than 24 hours;
2. Short-term: the device is expected to be used continuously for a period of more than 24 hours and less than 30 days;
3. Long-term: the device is expected to be used continuously for a period of more than 30 days;
4. Continuous duration of use: 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 devices that come into contact with the following parts:
(1) skin: only contact with the surface of the skin is undamaged;
(2) mucous membranes: devices that come into contact with the mucous membranes;
(3) skin: only contact with the surface of the skin;
(4) the use of parts of the body and device:
5. the use of the device: the use of the device to prevent the patient from suffering a serious injury;
6. the use of the device to prevent the patient from suffering a serious injury;
8. p>(3) Injured surface: instruments that come into contact with a wound or other injured body surface.
3. Surgical invasive instruments:With the aid of surgery, instruments that invade the body, in whole or in part, through the surface of the body, and come into contact with the following
(1)Vascular:Invasive blood vessels that come into contact with a point on the blood pathway; instruments that act as a conduit for input into the vascular system;
(2)Tissue/Bone/Dental:Invasive instruments and materials that come into contact with the tissues, bone, and pulp/dentin system;
(3)Injured surfaces:Contact with wounds or other injuries to a wound or other injured surface of the body. system;
(3)Circulation:Instruments that contact the circulatory system.
(5) Implanted devices:Any device that is introduced into the human body or a natural cavity, in whole or in part, with the aid 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 time of at least 30 days, is considered
to be an implanted device.
(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 in surgery for cutting, slashing, drilling, sawing, grasping, scraping, clamping,
drawing, pinching, or a similar surgical procedure, not connected to any active instrument, and that can be reused through certain processing.
(viii) Central circulatory system: means the pulmonary artery, aorta, coronary artery, carotid artery, cerebral
artery, cardiac vein, superior vena cava, and inferior vena cava of the human blood circulation.
(ix) Central Nervous System: refers to the brain, meninges, and spinal cord.