The State Drug Administration has developed a "medical device classification rules"
Article 1
In order to standardize the classification of medical devices, according to the "supervision and management of medical devices regulations", the development of these rules.
Article 2
Medical devices are: instruments, equipment, appliances, materials or other items, including the required software, that are used individually or in combination in 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.
The effects of its use on the human body surface and in the body are 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 determine 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 three aspects of a comprehensive determination.
The specific determination of medical device classification can be based on the "Medical Device Classification Determination Table" (see annex).
Article 5
Basis for the determination of medical device classification
(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 based on different intended purposes. Among them:
1, the use of passive devices in the form of: drug delivery and preservation devices; change blood, body fluids devices; medical 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 and monitoring devices; delivery of body fluids devices; ionizing radiation devices; laboratory instruments and equipment, medical disinfection equipment; other active devices or active auxiliary equipment and so on.
(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 with or into the human body devices and non-contact human body devices, specifically can be divided into:
1, contact with or into the human body devices
(1) the time limit for use is divided into: temporary use; short-term use; long-term use. ; long-term use.
(2) contact with the human body is divided into: skin or cavity; trauma or body tissues; blood circulation system or central nervous 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 of the degree is divided into: basically does not affect; there is an indirect effect; there is an important effect
Article VI
Determination of the implementation of the principles of classification of medical devices
(a) implementation of the classification of medical devices should be based on the classification of the table of determination.
(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, 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 to its classification
Article VII
State Drug Administration in charge of the classification of medical devices. Based on 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 preclassification, and reported to the State Drug Administration for approval
Article VIII
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 achieved. medical device should be achieved.
(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 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 in the actual occurrence of the time of action.
(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 devices that come into contact with:
(1) skin: devices that contact only the surface of undamaged skin;
(2) mucous membranes: devices that come into contact with the mucous membranes;
(3) injury surfaces: devices that come into contact with wounds or other injuries to the body surface.
3. Surgical invasive instruments: with the aid of surgery, instruments that invade the body, in whole or in part, through the body surface, in contact with the following parts of the body, including the following parts of the body:
(1) vascular: invasion of blood vessels in contact with a point on the blood path; as a conduit to the vascular system into the instrument;
(2) tissues / bone / dental: invasion of tissues, bone and dental pulp / dental system of instruments and materials;
(3) Blood circulation: instruments that contact the blood circulation system.
(5) Implanted instruments: any instruments which, with the aid of a surgical procedure, are introduced in whole or in part into the human body or into a natural cavity; which remain in the body for a prolonged period of time after the surgical procedure has been completed, or which remain partially in the body for at least 30 days, are considered to be 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 in surgery for cutting, slashing, drilling, sawing, grasping, scraping, pincering, extracting, clamping, or similar surgical procedures, is not connected to any active instrument, and 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
Article IX
These rules by the State Drug Administration is responsible for the interpretation of the State Drug Administration
Article X
These rules from April 10, 2000 onwards.