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 A medical device is defined as: an instrument, equipment, apparatus, material or other
item, including the required software, that is used individually or in combination for the human body. 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.
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 3 These rules are used to guide the development of the Classification Catalog of Medical Devices and to identify 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
Medical devices used in the situation of the three aspects of a comprehensive decision.
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 to determine the basis
(a) the structural characteristics of medical devices
Structural characteristics of medical devices are divided into: active medical devices and passive medical devices.
(ii) medical device use form
Based on different intended purposes, medical devices are categorized into certain forms of use. Among them:
1. Passive devices in the form of use are: drug delivery and preservation devices; change blood, body fluids devices; medical dressings; surgical
departmental devices; reuse surgical devices; disposable sterile devices; implantable devices; contraception and family planning devices; disinfection 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; delivery of body fluids devices; ionizing radiation
devices; laboratory instrumentation 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 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 devices
(1) the time limit for the use of: temporary use; short-term use; long-term use. Use; short-term use; long-term use.
(2) the site of contact with the human body is divided into: skin or cavity; trauma or body tissues; blood 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 damage; 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; there is an indirect effect; there is an important effect.
Article VI Implementation of medical device classification decision-making principles
(1) Implementation of medical device classification, should be based on the classification decision 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.
(E) control the function of the medical device software and the medical device is classified according to the same category.
(vi) If a medical device can apply 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.
(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
integrated its classification.
Article VII of the State Drug Administration in charge of medical device classification. 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 of
classes, 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 obtained
use.
(ii) 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 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, 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: mucous membranes in contact with the device;
(3) damaged surfaces: only contact with the surface of the skin;
(4) the use of parts of the device:
5. the use of the device: the use of the device to prevent the patient from being injured. p>(3) Injured surfaces: instruments that come into contact with wounds or other injured body surfaces.
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 that come into contact with parts of the body that include the following
(1) vascular: invading blood vessels that come into contact with a point on the blood pathway; instruments that act as a conduit to the vascular system;
(2) tissue/bone/dentine: instruments and materials that invade the tissues, bone, and pulp/dentine system;
(3) blood circulation: instruments that contact the blood circulation system.
(5) Implanted device: 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 at least 30 days, are 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, pincering,
drawing, clamping or similar surgical procedures, without any active instrument attached, and that can be reused through certain processing.
(viii) Central circulatory system: the pulmonary artery, aorta, coronary arteries, carotid 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.