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 These rules are used to guide the development of medical device classification catalog and determine the management category of new medical devices. Article III of these rules the meaning of the relevant terms are: (a) the intended purpose of the product specification, labeling or promotional materials contained in the use of medical devices should be achieved. (B) passive medical device does not rely on electricity or other energy sources, but can be generated by the human body or gravity, the function of the medical device. (C) active medical devices 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 functions. (D) invasive devices with the aid of surgery, in whole or in part through the body surface invasion of the human body, contact with the body tissues, blood circulation system, the central nervous system and other parts of the medical device, including interventional surgery in the use of equipment, single-use sterile surgical instruments and temporary or short-term stay in the body of the device. The invasive instruments in this rule do not include reusable surgical instruments. (E) Reusable surgical instruments Used in surgery to cut, cut, drill, saw, scratch, scrape, pincer, pump, clip and other processes, not connected to any active medical devices, through certain processing can be reused passive medical devices. (F) implanted devices with the help of surgery, in whole or in part into the body or cavity (mouth), or used to replace the human epithelial surface or the surface of the eye, and at the end of the surgical process to remain in the body for more than 30 days (including) or be absorbed by the human body of the medical device. (VII) contact with the human body devices directly or indirectly in contact with the patient or can enter the patient's body medical devices. (H) the use of time limit 1. continuous use time: medical devices according to the intended purpose, the actual duration of uninterrupted action; 2. temporary: the expected continuous use of medical devices within 24 hours; 3. short-term: the expected continuous use of medical devices in the 24 hours (including) or more, 30 days or less; 4. long term: medical devices are expected to be used continuously for more than 30 days (including). (ix) Skin Undamaged skin surface. (J) cavity (mouth) oral cavity, nasal cavity, esophagus, external auditory canal, rectum, vagina, urethra and other natural cavities of the human body and permanent artificial openings. (XI) trauma a variety of injury-causing factors in the human body caused by the destruction of the structural integrity of the tissue or dysfunction. (XII) tissue human body tissues, including bone, dental pulp or dentin, excluding the circulatory system and the central nervous system. (xiii) Circulatory system Blood vessels (except capillaries) and the heart. (xiv) Central nervous system Brain and spinal cord. (xv) Stand-alone software Software that has one or more medical purposes, does not require medical device hardware to accomplish its intended purpose, and runs on a common computing platform. (xvi) Medical devices with metrological testing functions Medical devices used to determine physiological, pathological, or anatomical parameters, or to quantify energy or substances moving in and out of the body, where the results of the measurements need to be accurately quantified, and where the accuracy of the results would have a significant impact on the health and safety of the patient. (XVII) Chronic wounds Long-term non-healing wounds formed by various causes, such as venous ulcers, arterial ulcers, diabetic ulcers, traumatic ulcers, pressure ulcers and so on. Article IV medical devices in accordance with the degree of risk from low to high, the management category is divided into Category I, Category II and Category III in turn. Medical device risk level, should be based on the intended purpose of the medical device, through the structural features, the use of forms, the use of state, whether contact with the human body and other factors to determine the comprehensive. Article 5 According to the factors affecting the degree of risk of medical devices, medical devices can be divided into the following situations: (a) According to the different structural features, divided into passive medical devices and active medical devices. (B) according to whether contact with the human body, divided into contact with the human body and non-contact human body devices. (c) According to different structural features and whether contact with the human body, the use of medical devices in the form of: passive contact with the human body devices: liquid delivery devices, change the blood and body fluids devices, dressings, invasive devices, re-use of surgical instruments, implantation devices, contraception and family planning devices, other passive contact with the human body devices. Passive non-contact devices: nursing instruments, medical equipment cleaning and disinfection equipment, other passive non-contact devices. Active contact with human devices: energy therapy devices, diagnostic and monitoring devices, liquid delivery devices, ionizing radiation devices, implantable devices, other active contact with human devices. Active non-contact human devices: clinical testing instruments and equipment, independent software, medical device sterilization equipment, other active non-contact human devices. (d) According to different structural features, whether contact with the human body and the form of use, the use of medical devices or their impact includes the following situations: passive contact with the human body devices: according to the time limit for use is divided into temporary use, short-term use, long-term use; contact with the human body is divided into parts of the skin or cavities (mouths), wounds or tissues, the blood circulatory system or the central nervous system. Passive non-contact human body devices: according to the degree of impact on the medical effect is divided into basically no impact, slight impact, important impact. Active contact human devices: according to the degree of damage that may be caused by loss of control is divided into minor damage, moderate damage, serious damage. Active non-contact human devices: according to the degree of influence on the medical effect is divided into basic non-influence, slight influence, important influence. Article 6 The classification of medical devices shall be classified according to the medical device classification judgment table (see annex). With the following circumstances, should also be combined with the following principles for classification: (a) If the same medical device applies to two or more classifications, should take the classification of which the highest degree of risk; by more than one medical device package consisting of medical devices, its classification should be consistent with the package of the highest degree of risk of the medical device. (B) can be used as an accessory to the medical device, its classification should be comprehensive consideration of the accessory to the supporting body of the medical device safety, effectiveness of the impact; if the accessory to the supporting body of the medical device has an important impact, the classification of the accessory should be no less than the supporting body of the classification of medical devices. (C) monitor or influence the main function of the medical device, its classification should be consistent with the classification of the medical device being monitored and influenced. (D) The combination products of medicines and devices with the main function of medical devices shall be managed in accordance with Class III medical devices. (E) Medical devices that can be absorbed by the human body, in accordance with the management of Class III medical devices. (F) The active contact with the human body devices that have an important impact on the medical effect, in accordance with the management of Class III medical devices. (vii) Medical dressings are managed in accordance with Class III medical devices if they are: expected to have the function of preventing the adhesion of tissues or organs, used as artificial skin, in contact with the deep dermis or its following tissue damaged wounds, used for chronic wounds, or can be absorbed by the body in whole or in part. (viii) Medical devices provided in a sterile form, which shall be classified no lower than Class II. (Ix) through the pulling, bracing, twisting, pressure grip, bending and other action, active application of sustained force on the human body, can be dynamically adjusted limb fixed position of the orthopaedic device (excluding only with the role of fixation, support of the medical device, also does not include with the surgical operation for temporary orthopaedic medical devices or post-surgical or other treatment of limb orthopaedic medical devices), its classification should be not less than Class II. (x) Medical devices with measurement and testing functions shall be classified not lower than Class II. (xi) If the intended purpose of the medical device is to be used explicitly for the treatment of a disease, its classification shall be not lower than Class II. (XII) Passive reusable surgical instruments used to complete surgical operations such as clamping, cutting tissue or stone removal under endoscopy shall be managed in accordance with Class II medical devices. Article 7 In vitro diagnostic reagents are classified in accordance with relevant regulations. Article 8 The State Food and Drug Administration in accordance with the production, operation and use of medical devices, timely analysis and evaluation of the risk of changes in medical devices, and adjust the classification of medical devices. Article 9 The State Food and Drug Administration may organize an expert committee on medical device classification to develop and adjust the medical device classification directory. Article X These rules shall come into force on January 1, 2016.The Rules for Classification of Medical Devices published on April 5, 2000 (former State Drug Administration Decree No. 15) shall be repealed at the same time.