Article I 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 devices are: instruments, equipment, appliances, 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 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.
Its use on the human body surface and in vivo is not obtained by pharmacological, immunological or metabolic means, but may have these
means 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 determines 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
Mechanical use of the situation of the three aspects of a comprehensive judgment.
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 based on judgment
(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
According to the 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 blood, body fluids devices; dressings; surgical
devices; reuse surgical devices; disposable sterile devices; implantable devices; contraception and family planning devices; disinfection and cleaning
clean devices; nursing devices, in vitro diagnostic reagents, other passive contact or passive auxiliary device 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 equipment, medical disinfection equipment; other active devices or active auxiliary equipment.
(C) the use of medical devices
According to 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 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 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 tissue; blood circulation 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 devices
The impact on the medical effect, the degree is divided into: basically does not affect; have indirect impact; have an important impact.
Article VI Implementation of the principles of medical device classification
(a) The implementation of medical device classification, should be based on the classification of the judgment table.
(b) The classification of medical devices is mainly based on the 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 medical devices, should be classified separately; classification of medical equipment accessories
should be separated from its supporting host, according to the annexes of the separate classification.
(D) role in several parts of the human body, medical devices, according to the use of high-risk 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 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
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
classification, and reported to the State Drug Administration for approval.
Article VIII of the Rules of 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.
(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 The time of continuous use: the device according to the intended purpose, without interruption of the actual occurrence of the effect of time.
(D) the use of parts and devices:
1. non-contact devices: not directly or indirectly in contact with the patient's device;
2. surface contact devices: including the following parts of the contact with the device:
(1) skin: only contact with the undamaged skin surface of the device;
(2) mucous membranes: mucous membranes in contact with the device;
(3) damaged surfaces: only contact with the skin surface;
(3) damaged surfaces. p> (3) Injured surfaces: instruments in contact with wounds or other injured body surfaces.
3. Surgical invasive devices: with the aid of surgery, the device all or part of the body through the body surface invasive body, contact with the following
parts of the device:
(1) vascular: invasive blood vessels in contact with the blood path at a certain point; as a conduit to the vascular system into the device;
(2) tissue / bone / dental: invasive tissues, bone and pulp / dental system of instruments and materials;
(2) bone / dental: invasive tissue, bone and pulp / dental system;
(3) Circulation: instruments that contact the circulatory system.
(5) Implanted devices: Any device that is surgically inserted, in whole or in part, into the human body or into a natural cavity; that remains in the body for a prolonged period of time after the surgical procedure has been completed; or that remains partially in the body for a period of at least 30 days is considered 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 instruments: refers to instruments used in surgery for cutting, slashing, drilling, sawing, grasping, scraping, tongs,
pumping, 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, aorta, coronary arteries, carotid arteries, cerebral
arteries, cardiac veins, superior vena cava, and inferior vena cava in the circulation of the human body.
(ix) Central nervous system: refers to the brain, meninges, spinal cord.