Article 2 These Rules are used to guide the formulation of medical device classification catalogue and the determination of new medical device management categories.
essay
The meanings of relevant terms in these Rules are:
(1) intended purpose
Refers to the functions that should be realized in the use of medical devices as stated in product manuals, labels or promotional materials.
(2) Passive medical equipment
Medical devices that can function through energy generated by human body or gravity without relying on electric energy or other energy sources.
(3) Active medical devices
Any medical device that relies on electric energy or other energy sources, rather than the energy directly generated by human body or gravity.
(4) invasive instruments
All or part of medical instruments that invade the human body through body surface and come into contact with tissues, blood circulation system, central nervous system and other parts of the body through surgery, including instruments used in interventional surgery, disposable sterile surgical instruments and instruments temporarily or temporarily left in the human body. Invasive instruments in this rule do not include reusable surgical instruments.
(5) Reuse surgical instruments.
It is used for cutting, cutting, drilling, sawing, grasping, scraping and clamping. During the operation. It is a passive medical device, which can be reused through certain treatment without connecting any active medical devices.
(6) Implanting instruments
Medical devices that enter the human body or cavity (mouth) completely or partially through surgery, or are used to replace the epithelial surface or eye surface of the human body, and remain in the human body for more than 30 days (inclusive) or are absorbed by the human body after surgery.
(seven) contact with human instruments
Medical devices that directly or indirectly contact patients or can enter patients.
(8) Term of use
1. Continuous use time: the actual uninterrupted working time of medical devices according to their intended use;
2. Temporary: the expected continuous use time of medical devices is less than 24 hours;
3. Short-term: the expected continuous use time of medical devices is more than 24 hours and less than 30 days;
4. Long-term: The expected continuous use time of medical devices exceeds 30 days (inclusive).
(9) skin
The skin surface is intact.
(10) cavity (mouth)
Oral cavity, nasal cavity, esophagus, external auditory canal, rectum, vagina, urethra and other natural human cavities and permanent artificial openings.
(1 1) trauma
Various injury factors act on human body, leading to the destruction of organizational structure integrity or dysfunction.
(12) organization
Tissue in human body, including bone, pulp or dentin, excluding blood circulation system and central nervous system.
(13) blood circulation system
Blood vessels (except capillaries) and the heart.
(14) Central nervous system
Brain and spinal cord.
(15) independent software
Software that has one or more medical uses, can complete the expected use without medical device hardware, and runs on a general computing platform.
(sixteen) medical devices with the function of measurement and detection.
Medical instruments used to measure physiological, pathological and anatomical parameters, or to quantitatively measure energy or substances entering or leaving the human body, the measurement results need to be accurately quantified, and the accuracy of the results will have a great impact on the health and safety of patients.
(XVII) Chronic wounds
Long-term unhealed wounds caused by various reasons, such as venous ulcer, arterial ulcer, diabetic ulcer, traumatic ulcer, pressure sore, etc.
Article 4 Medical devices are classified into Category I, Category II and Category III according to the degree of risk from low to high.
The risk degree of medical devices should be comprehensively judged according to the expected use of medical devices, through structural characteristics, use forms, use status, contact with human body and other factors.
Article 5 According to the factors that affect the risk degree of medical devices, medical devices can be divided into the following situations:
(a) according to the different structural characteristics, it is divided into passive medical devices and active medical devices.
(2) According to whether it touches the human body or not, it can be divided into contact human body devices and non-contact human body devices.
(three) according to the different structural characteristics and whether it is in contact with the human body, the use forms of medical devices include:
Passive contact devices: liquid delivery devices, devices for changing blood and body fluids, medical dressings, invasive devices, reusable surgical devices, implant devices, contraceptive and family planning devices and other devices that passively contact the human body.
Passive non-contact human equipment: nursing equipment, medical equipment cleaning and disinfection equipment, and other passive non-contact human equipment.
Active human contact devices: energy therapy devices, diagnostic monitoring devices, liquid delivery devices, ionizing radiation devices, implant devices and other active human contact devices.
Active non-contact human body instruments: clinical inspection instruments and equipment, independent software, medical instrument disinfection and sterilization equipment, and other active non-contact human body instruments.
(four) according to the different structural characteristics, whether it is in contact with the human body and the use form, the use state or its influence of medical devices includes the following situations:
Passive contact with human body equipment: according to time limit, it can be divided into temporary use, short-term use and long-term use; Contact with human body is divided into skin or cavity (mouth), trauma or tissue, blood circulation system or central nervous system.
Passive non-contact human body equipment: according to the degree of influence on medical effect, it can be divided into basically no influence, slight influence and important influence.
Active contact with human equipment: according to the possible degree of injury after losing control, it can be divided into minor injury, moderate injury and serious injury.
Active non-contact human body equipment: according to the degree of influence on medical effect, it can be divided into basically no influence, slight influence and important influence.
Article 6 The classification of medical devices shall be judged according to the Classification Judgment Table of Medical Devices (see Annex). In any of the following circumstances, it shall also be classified according to the following principles:
(1) If more than two classifications are applied to the same medical device, the classification with the highest risk shall be adopted; The classification of medical device packages composed of multiple medical devices should be consistent with the medical devices with the highest risk in the package.
(two) the classification of medical devices that can be used as accessories should comprehensively consider the impact of accessories on the safety and effectiveness of supporting medical devices; If the accessories have an important impact on the supporting main medical devices, the classification of the accessories should be no less than that of the supporting main medical devices.
(3) The classification of medical devices that monitor or affect the main functions of medical devices should be consistent with the classification of medical devices that are monitored and affected.
(four) medical device products combined with the main functions of medical devices shall be managed in accordance with the third category of medical devices.
(5) Medical devices that can be absorbed by the human body shall be managed in accordance with Class III medical devices.
(six) active contact with human devices that have an important impact on medical effects shall be managed in accordance with Class III medical devices.
(7) If the medical dressing is expected to have the function of preventing the adhesion of tissues or organs, it should be used as artificial skin, contact with wounds in deep dermis or tissues under it, be used for chronic wounds, or be absorbed by the human body in whole or in part, it should be managed according to the third category of medical devices.
(eight) the classification of medical devices provided in sterile form shall not be lower than the second category.
(9) Orthopedic instruments that exert continuous force on human body by pulling, stretching, twisting, pressing, bending, etc., and can dynamically adjust the fixed position of limbs (excluding medical instruments that only have the functions of fixing and supporting, and also excluding medical instruments that cooperate with temporary orthopedic surgery or medical instruments that correct limbs after surgery or other treatments), the classification shall not be lower than the second category.
(10) The classification of medical devices with metrological detection function shall not be lower than the second category.
(eleven) if the intended use of medical devices is to treat a disease, its classification should not be lower than the second category.
(12) Reusable passive surgical instruments used for grasping, cutting tissues or taking stones under endoscope should be managed according to Class II medical instruments.
Article 7 In vitro diagnostic reagents shall be classified according to relevant regulations.
Article 8 China Food and Drug Administration shall, according to the production, operation and use of medical devices, timely analyze and evaluate the risk changes of medical devices and adjust the classified catalogue of medical devices.
Article 9 The State Food and Drug Administration may organize an expert committee on the classification of medical devices to formulate and adjust the classification catalogue of medical devices.
Article 10 These Rules shall come into force as of1October 2006, 2065438+ 1 day. On April 5, 2000, the Classification Rules of Medical Devices (the former National Medical Device Product Management OrderNo. 15) was abolished at the same time.
How to classify common medical devices 1. Classification according to the degree of danger of medical devices 1. The first category: medical devices with low risk can ensure their safety and effectiveness through daily management. Such as surgical handles and blades, skin flap knives, wart peeling knives, The Lancet, shovels, razors, dander scrapers, pick knives, front knives, pedicure knife, nail knives, scalpels, etc.
2. Category II: Medical devices with moderate risks that need strict control and management to ensure their safety and effectiveness. Such as general diagnostic instruments (thermometers, sphygmomanometers), physiotherapy rehabilitation equipment (magnetic therapy equipment), clinical examination and analysis instruments (home blood glucose analyzer, test paper), operating room, emergency room, consulting room equipment and appliances (medical small oxygen generator, portable oxygen generator), medical health materials and dressings (medical absorbent cotton, medical absorbent gauze), medical polymer materials and products (condoms, medical absorbent gauze).
3. Category III: High-risk medical devices that need to be strictly controlled and managed by special measures to ensure their safety and effectiveness. Such as disposable sterile medical devices (disposable sterile syringes, disposable infusion sets, disposable blood transfusions, disposable anesthesia puncture kits, disposable intravenous infusion needles, disposable sterile injection needles, disposable plastic blood bags, disposable blood collectors and disposable burette infusion sets), orthopedic implant medical devices (surgically implanted joint prostheses, disposable sterile medical devices, hearing AIDS, contact lenses and nursing solutions, in vitro diagnostic reagents, 6846.
Second, according to the classification of medical devices 1, family health care devices.
Pain massage equipment, home health self-inspection equipment, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, laser therapeutic instrument, blood glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene products, and home first aid products; Electric massage chair/bed, massage stick, massage hammer, massage pillow, massage cushion, massage belt, qi and blood circulation machine, foot bath tub, foot massager, hand massager, massage bathtub, fat-throwing belt, therapeutic instrument, foot physiotherapy instrument, weight-reducing belt, car cushion, kneading pad, massage chair, breast augmentation device, beauty massager, etc.
2. Family medical rehabilitation equipment
Household cervical vertebra and lumbar vertebra tractor, traction chair, physiotherapy instrument, sleeping instrument, massager, functional chair, functional bed, bracket and medical inflatable air cushion; Oxygen generator, decocting device, hearing aid, etc.
3. Home care equipment
Family rehabilitation nursing AIDS, female pregnant and baby care products, household gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box, sphygmomanometer, blood glucose meter, nursing bed, etc.
4. Medical devices commonly used in hospitals
Trauma treatment vehicle, operating table, operating lamp, monitor, anesthesia machine, ventilator, blood cell analyzer, differentiation analyzer, enzyme-labeled instrument, washing machine, urine analyzer, ultrasonic instrument (color ultrasound, B ultrasound, etc. ), X-ray machine, nuclear magnetic resonance, etc.