(Order No. 15 of SDA) The Provisions for Medical Device Classification were pasd by the State Drug Administration at the administration affairs meeting on February 17 of 2000, are hereby promulgated and shall go into effect as of April 10, 2000. Zheng Xiaoyu
Director- General of State Drug Administration
April 5, 2000
Provisions for Medical Device Classification
to letArticle1 The Provisions are stipulated in accordance with the Regulation on Supervision and Administration of Medical Device to standardize the classification of medical devices.
Article2 "Medical devices" refer to tho instruments, equipment, tools, materials and other objects, including the software attached to them, that are designed to be ud either independently or in combination on human body. The devices are ud for: 1.Prevention, diagnosis, treatment, monitoring or remission of dias; 2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability; 3.Rearch, replacement or adjustment of anatomical or physiological process; 4. Control of pregnancy. Basically, the effect of the devices on human body is not achieved through means of pharmacology, immunology or metabolism; though they might be resorted to in order to bring about certain supplementary effect.
Article3 The Provisions are meant to direct the formulation of The Category of Medical Device Classification as well as to determine the class of newly registered products.
Article 4 The classification of medical devices should be determined by a combined judgement on three respects: its structural characteristics, form of operation as well as conditions for u.
Specifically, their classification can be bad on Criteria for Medical Device Classification (e appendix).
Article 5 Guidelines for Medical Device Classification
1. The structural characteristics of medical devices According to their respective structural characteristics, medical devices are divided into active and passive devices. 2. The forms of operation of medical devices Medical devices are designated into different forms of operation in accordance with their intended purpos. r1) Passive devices in terms of their form of operation can be classified as device ud for transportation and storage of pharmaceutical liquid, device for alteration of blood, body fluids, medical dressing, surgical instruments;
reusable surgical instruments, disposable aptic device, implantable device, device for contraception and birth control, device for sterilization and cleaning, patient care device, in vitro diagnostic reagent, as well as other passive contacting device or passive supplementary device. 2) Active devices in terms of their form of operation can be classified as device for treatment through energy, diagnostic monitoring, body fluids transportation and ionized radiation, laboratory instruments and medical sterilizer; as well as other active contacting device or active supplementary device. 3. The conditions for u of medical devices: Medical devices may be divided into contacting or inrted devices and non-contacting devices bad on their conditions for u, which include the possible injuries they might entail as well as their impact on the medical treatment. 1) Contacting or inrted devices a. Term of u: temporary u, short - term u, long-term u;
b. Particular parts of the human body being contacted:暗黄皮肤如何美白
skin, cavity and tract; trauma or body tissue; blood circulation system or central nervous system;
c. The degree of injuries caud by malfunction of active devices:
minor injuries, injuries, rious injuries. 2) Non-contacting Devices The impact the devices have on treatment ranges from: basically no impact, indirect impact, substantial impact.
Article 6 Principles for Medical Device Classification
1. The classification of medical devices should be conducted in accordance with The Criteria for Medical Device Classification. 2. The criteria for medical device classification are bad on the intended purpo and the function of a medical device. To the same product, if the intended purpo or form of operation be different, its class shall be determined respectively. 3. For the medical device to be ud in combination with another, the classification of each should then be dealt with parately. Accessories to medical devices should be classified independently from the master device respecting its own conditions. 4. For the medical device to be ud on veral parts of the human body, the classification should be determined on the basis of the risks involved in its intended purpos and form of operation. 5. Software that controls the functions of the medical device should be designated to the same class of its associated medical device. 6. If one medical device pertains to two class at the same time, the higher one is adopted. 7. Tho products that are designed to monitor or affect the major functions of a medical device should be designated to the same class of the device being monitored or affected. 8. The State Drug Administration shall readjust as it es fit the classification of certain medical devices that call for special administration.
Article 7 The State Drug Administration is competent authority take charge of the classification of medical devices. In ca a medical device fails to be designated according to The Category of Medical Device Classification, its classification then should be bad on The Regulation for Medical Device Classification at the discretion of the provincial drug administration, the result of which should be submitted to the State Drug Administration for approval.
Article 8 The terms ud in the provisions are defined as follows:
1. Intended purpo: the desired effect of a medical device that is illustrated in its product specification, label or materials for publicity.afinitor 2. Risk: the possible injuries that may be caud by the medical device and the riousness of the injury. 3.Term of u: 1) Temporary U: the intended term for concutive u of the device is within 24 hours;
2) Short-term U: the intended term for concutive u of the device ranges from 24 hours to 30 days;
3) Long-term U: the intended term for concutive u of the device is more than 30 days.
4) Term for concutive u: the actual working time of a device without any stop in accordance with its intended purpo. 名词所有格4. Parts being operated upon and the device: 1) Non-contacting devices: devices that do not directly or indirectly contact the body of a patient;
2) Surface contacting devices: including devices contacting the following parts of the human body: a. skin: devices that only contact the surface of the unwounded skin; b. mucous membrane: devices that contact the mucous membrane; c. wounded surface: devices that contact the wounded area or the surface of other injured areas. 英文绕口令3) Devices for surgical inrtion: devices that are entirely or partly inrted into the body through the surface of body by surgery contacting the following parts of the human body: a. blood vesl: inrted devices contacting a point on a blood vesl or as a channel to the blood vesl system. b. tissue/bone/dentinum: devices and materials that are inrted into the tissue, bones as well as endodontium/dentinum system. c. blood circulation: devices that contact the blood circulation system. 5.Implantables: devices that are entirely or partly inrted into the cavity or tract of the human body by surgery. The devices either remain in the body over a long period of time, or partly remain in the body for at least 30 days. 6. Active device: any medical device that operates on electric power or other forms of energy excluding tho directly generated by human body or gravity. 7. Reusable surgical instruments: devices that are ud to conduct such procedures during a surgery as excision, boring, sawing, clutching, scraping, clipping, drawing and clamping without having to resort to any active device and that can be reud after certain treatment. 8.Central Circulation System: referring to a number of vesls of the blood circulation system including pulmonary artery, aorta, coronary artery, carotid artery, cerebral artery, cardiac vena, upper cavity vena, and lower cavity vena. 9. Central Nervous System: referring to cerebrum, meninx and medulla spinalis.
Article 9 The State Drug Administration is responsible for interpretation of the provisions.
Article 10 The Provisions shall go into effect as of April 10, 2000.
Criteria for Medical Devices Classification download
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