"Medical Device Classification Rules" (State Food and Drug Administration Order No. 15)

Rules for the Classification of Medical Devices

　　 Article 1 　 is to standardize the classification of medical devices. This rule is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
　　 Article 2 　 This rule is used to guide the formulation of a medical device classification catalog and determine the management category of new medical devices.
　　Article 3　The meaning of the relevant terms in this rule is:
　　 (1) Expected purpose
　　 refers to the effects that should be achieved by using medical devices as stated in product manuals, labels or promotional materials.
　　 (two) passive medical devices
　　A medical device that does not rely on electricity or other energy sources, but can perform its functions through energy generated by the human body or gravity.
　　 (3) Active medical devices
　　Any medical device that relies on electrical energy or other energy sources instead of energy directly generated by the human body or gravity to perform its functions.
　　 (4) Invasive devices
Invade the human body completely or partly through the body surface by means of surgery, and contact medical devices such as body tissues, blood circulation system, central nervous system, etc., including those used in interventional surgery, disposable sterile surgical instruments and temporary or short-term stay Equipment in the body, etc. Invasive devices in this rule do not include reused surgical devices.
　　 (5) Repeated use of surgical instruments
　　 Passive medical devices that are used for cutting, cutting, drilling, sawing, grasping, scraping, forceps, pulling, clamping, etc., without connecting any active medical devices, and can be reused through certain treatments.
　　(6) Implanted devices
Medical devices that enter the human body or cavity (orifice) in whole or in part by means of surgery, or are used to replace the epithelial surface or ocular surface of the human body, and remain in the human body for more than 30 days (inclusive) or absorbed by the human body after the operation process .
　　 (7) Devices that touch the human body
　　A medical device that directly or indirectly contacts the patient or can enter the patient's body.
　　 (eight) use time limit
　　1. Continuous use time: the actual, uninterrupted actual action time of the medical device according to the intended purpose;
　　 2. Temporary: The expected continuous use time of the medical device is within 24 hours;
　　3. Short-term: The expected continuous use time of the medical device is more than 24 hours (inclusive) and within 30 days;
　　4. Long-term: The expected continuous use time of medical devices is more than 30 days (inclusive).
　　 (9) skin
　　 Undamaged skin surface.
　　 (十) Cavity Dao (kou)
　　 Oral cavity, nasal cavity, esophagus, external auditory canal, rectum, vagina, urethra and other human natural cavities and permanent artificial openings.
　　 (11) trauma
　　 Various injury-causing factors act on the human body to cause damage to the integrity of the tissue structure or dysfunction.
　　 (twelve) organization
　　 Human body tissues, including bone, dental pulp or dentin, excluding blood circulatory system and central nervous system.
　　 (thirteen) blood circulation system
　　 Blood vessels (except capillaries) and the heart.
　　 (fourteen) central nervous system
　　 Brain and spinal cord.
　　 (15) Independent Software
　　 has one or more medical purposes, does not require medical device hardware to complete its intended purpose, software running on a general computing platform.
　　 (16) Medical devices with measurement and test functions
　　Medical devices used to determine physiological, pathological, anatomical parameters, or quantitatively determine the energy or substances entering and leaving the human body. The measurement results need to be accurately quantified, and the accuracy of the results will have a significant impact on the health and safety of patients.
　　 (17) Chronic wounds
　　 Long-term non-healing wounds formed by various reasons, such as venous ulcer, arterial ulcer, diabetic ulcer, traumatic ulcer, pressure ulcer, etc.
　　Article 4　Medical devices are classified into the first category, the second category and the third category according to the degree of risk from low to high.
　　 The degree of risk of a medical device should be comprehensively determined based on the intended purpose of the medical device, through structural features, use form, use status, and whether it is in contact with the human body.
　　Article 5　 According to the factors that affect the degree of risk of medical devices, medical devices can be divided into the following situations:
　　 (1) According to different structural characteristics, it is divided into passive medical devices and active medical devices.
　　 (2) According to whether it is in contact with the human body, it is divided into human-contacting devices and non-human-contacting devices.
　　 (3) According to different structural characteristics and whether it is in contact with the human body, the use of medical devices includes:
　　 Passive human body contact devices: liquid delivery devices, blood and body fluid changing devices, medical dressings, invasive devices, repeated use surgical devices, implanted devices, contraceptive and family planning devices, and other passive body contact devices.
　　 Passive non-contact human body equipment: nursing equipment, medical equipment cleaning and disinfection equipment, and other passive non-human body equipment.
　　 Active human body contact equipment: energy therapy equipment, diagnostic monitoring equipment, liquid delivery equipment, ionizing radiation equipment, implanted equipment, and other active human body contact equipment.
　　 Active non-contact human body equipment: clinical testing equipment, independent software, medical equipment disinfection and sterilization equipment, and other active non-contact human body equipment.
　　 (4) According to different structural features, whether it is in contact with the human body, and the form of use, the state of use of medical devices or their impact include the following situations:
　　 Passive human body contact devices: according to the time limit of use, they are divided into temporary use, short-term use, and long-term use; the parts that contact the human body are divided into skin or cavity (mouth), trauma or tissue, blood circulation system or central nervous system.
　　 Passive non-contact human body devices: According to the degree of influence on the medical effect, it is divided into basically no influence, slight influence, and important influence.
　　 Active human body contact devices: According to the degree of damage that may be caused by loss of control, they are divided into minor damage, moderate damage, and severe damage.
　　 Active non-contact human body equipment: According to the degree of influence on the medical effect, it is divided into basically no influence, slight influence, and important influence.
　　Article 6　 The classification of medical devices shall be determined according to the classification judgment table of medical devices (see attachment). In the following situations, classification should also be combined with the following principles:
(1) If two or more classifications are applied to the same medical device, the classification with the highest risk level shall be adopted; for medical device packages composed of multiple medical devices, the classification shall be consistent with the medical device with the highest risk level in the package .
(2) For medical devices that can be used as accessories, their classification shall comprehensively consider the impact of the accessory on the safety and effectiveness of the supporting main medical device; if the accessory has an important influence on the supporting main medical device, the classification of the accessory shall not be lower than that of the supporting main Classification of 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 the medical devices that are monitored or affected.
　　 (4) Combination products of medicine and equipment with the main function of medical equipment shall be managed in accordance with the third category of medical equipment.
　　 (5) Medical devices that can be absorbed by the human body shall be managed in accordance with the third category of medical devices.
　　(6) Active human body-contacting devices that have an important impact on medical effects shall be managed in accordance with the third category of medical devices.
(7) Medical dressings shall be managed in accordance with the third category of medical devices in the following situations, including: expected to have the function of preventing adhesion of tissues or organs, as artificial skin, touching the deep layer of the dermis or the damaged wound surface, used for chronic wounds, Or it can be fully or partially absorbed by the human body.
　　 (8) The classification of medical devices provided in sterile form shall not be lower than the second category.
(9) Orthopedic devices that actively apply continuous force to the human body through pulling, spreading, twisting, crimping, bending, etc., which can dynamically adjust the fixed position of the limbs (excluding medical devices that only have fixed and supporting functions, It also does not include medical devices that are used for temporary correction during surgical operations or medical devices that perform limb correction after surgery or other treatment), and their classification should not be lower than the second category.
　　 (10) The classification of medical devices with measurement and test functions shall not be lower than the second category.
　　 (11) If the intended purpose of the medical device is to be clearly used in the treatment of a certain disease, its classification should not be lower than the second category.
　　 (12) Passive reusable surgical instruments used to complete surgical operations such as clipping, cutting tissue or removing stones under the endoscope, shall be managed in accordance with the second category of medical instruments.
"Article 7" In-vitro diagnostic reagents are classified in accordance with relevant regulations.
　　 Article 8 　 The State Food and Drug Administration shall analyze and evaluate the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjust the classification catalog of medical devices.
　　Article 9　The State Food and Drug Administration may organize a medical device classification expert committee to formulate and adjust the medical device classification catalog.
　　 Article 10 　 These rules shall come into effect on January 1, 2016. The "Medical Device Classification Rules" (formerly Order No. 15 of the State Drug Administration) promulgated on April 5, 2000 shall be repealed simultaneously.