Medical device classification rules
Article 1 In order to standardize the classification of medical devices, these rules are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 These rules are used to guide the development of medical device classification catalogues and to determine the management categories of new medical devices.
Article 3 The meaning of the terms used in these rules is:
(1) Expected purpose
Refers to the role that should be achieved when using medical devices as stated in the product manual, label or promotional materials.
(2) Passive medical devices
A medical device that does not rely on electrical energy or other energy sources, but can exert 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, rather than energy directly generated by the human body or gravity, to perform its function.
(4) Invasive devices
Surgery in whole or in part through the body surface, contact with medical equipment such as tissues, blood circulation system, central nervous system, etc., including equipment used in interventional surgery, disposable sterile surgical instruments, and temporary or short-term retention Instruments in the body, etc. Invasive devices in this rule do not include re-use of surgical instruments.
(5) Repeated use of surgical instruments
It is used in the process of cutting, cutting, drilling, sawing, grasping, scraping, pliers, pumping, clamping, etc., without connecting any active medical devices, and passive medical devices that can be reused through certain treatments.
(6) Implanted instruments
A medical device that enters the human body or the cavity (mouth) in whole or in part by surgery, or is used to replace the human epithelial surface or the ocular surface, and remains in the human body for more than 30 days (inclusive) or absorbed by the human body after the end of the surgical procedure. .
(7) Contact with human body equipment
A medical device that directly or indirectly contacts a patient or is able to enter the patient's body.
(8) Time limit for use
1. Continuous use time: the actual time of action of the medical device according to the intended purpose;
2. Temporary: The expected continuous use time of medical devices is within 24 hours;
3. Short-term: The expected continuous use time of medical devices is within 24 hours (inclusive) and less than 30 days;
4. Long-term: The expected continuous use time of medical devices is above 30 days (inclusive).
Undamaged skin surface.
(10) Cavity (port)
Oral, nasal cavity, esophagus, external auditory canal, rectum, vagina, urethra and other natural human passages and permanent artificial openings.
Various damage factors act on the structural integrity damage or dysfunction caused by the human body.
Tissues in the body, including bone, pulp or dentin, do not include the blood circulatory system and the central nervous system.
(13) Blood Circulatory System
Blood vessels (except for capillaries) and the heart.
(14) Central nervous system
Brain and spinal cord.
(15) Independent software
Software that runs on a general-purpose computing platform with one or more medical purposes, without the need for medical device hardware to perform its intended purpose.
(16) Medical devices with measurement and testing functions
Medical devices used to determine physiological, pathological, and anatomical parameters, or to quantify energy or substances entering and leaving the body, the measurement results need to be accurately quantified, and the accuracy of the results can have a significant impact on the health and safety of the patient.
(17) Chronic wounds
Long-term non-healing wounds formed by various reasons, such as venous ulcers, arterial ulcers, diabetic ulcers, traumatic ulcers, pressure ulcers, and the like.
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 medical device risk should be comprehensively determined according to the expected purpose of the medical device, through structural characteristics, use form, use status, and whether it is in contact with the human body.
Article 5 According to the factors affecting 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 contact human body equipment and non-contact human body equipment.
(3) According to different structural characteristics and whether it is in contact with the human body, the use forms of medical devices include:
Passive contact human instruments: liquid delivery devices, blood fluid changes, medical dressings, invasive devices, repetitive surgical instruments, implantable devices, contraceptive and family planning devices, and other passive contact human devices.
Passive non-contact human body equipment: nursing equipment, medical equipment cleaning and disinfecting equipment, and other passive non-contact human body equipment.
Active contact human body devices: energy therapy devices, diagnostic monitoring devices, liquid delivery devices, ionizing radiation devices, implantable devices, and other active contact human devices.
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 characteristics, whether it is in contact with the human body and the form of use, the state of use of the medical device or its effects includes the following situations:
Passive contact human body devices: divided into temporary use, short-term use, and long-term use according to the time limit; the parts touching the human body are divided into skin or cavity (mouth), wound or tissue, blood circulation system or central nervous system.
Passive non-contact human body devices: According to the degree of influence on medical effects, they are divided into basic non-influence, minor influence, and important influence.
Active contact human body devices: According to the degree of damage that may occur after loss of control, it is divided into minor damage, moderate damage, and serious damage.
Active non-contact human body devices: According to the degree of influence on medical effects, they are divided into basically no influence, slight influence, and important influence.
Article 6 The classification of medical devices shall be classified and judged according to the medical device classification judgment table (see attachment). In the following cases, it should also be classified according to the following principles:
(1) If two or more classifications are applied to the same medical device, the classification with the highest degree of risk should be adopted; the medical device package consisting of multiple medical devices should be classified in the same category as the medical device with the highest risk in the package. .
(2) The medical device that can be used as an accessory shall be classified into the impact of the accessory on the safety and effectiveness of the medical device of the supporting subject; if the accessory has an important influence on the medical device of the supporting subject, the classification of the accessory shall not be lower than the supporting subject. Classification of medical devices.
(3) The classification of medical devices that monitor or affect the main functions of medical devices shall be consistent with the classification of medical devices that are monitored and affected.
(4) Pharmaceutical and medical products based on the role 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 are managed in accordance with the third type of medical devices.
(6) Active contact human body devices that have an important impact on medical effects are managed in accordance with the third type of medical devices.
(7) Medical dressings are managed according to the third type of medical devices, including: anti-tissue or organ adhesion function, as artificial skin, contact with damaged wounds in the deep or underlying dermis, for chronic wounds, if Or it can be absorbed by the body in whole or in part.
(8) The medical equipment provided in aseptic form shall be classified not less than the second category.
(9) Actively applying orthopedic instruments that continuously exert a force on the human body and can dynamically adjust the fixed position of the limb by means of pulling, distracting, twisting, crimping, bending, etc. (excluding medical instruments having only fixed and supporting functions, It also does not include medical devices that are used for temporary orthopedic surgery during surgery or for the correction of limbs after surgery or other treatments. The classification should not be lower than the second category.
(10) Medical devices with measurement and testing functions shall be classified not less than the second category.
(11) If the intended purpose of a medical device is to be explicitly used for the treatment of a disease, its classification should not be lower than the second category.
(12) Passive reusable surgical instruments for performing surgical operations such as grasping, cutting tissue or stone removal under an endoscope, according to the second type of medical device management.
Article 7 In vitro diagnostic reagents are classified according to relevant regulations.
Article 8 The State Food and Drug Administration shall, in accordance with the production, operation and use of medical devices, timely analyze and evaluate the risk changes of medical devices and adjust the catalogue of medical devices.
Article 9 The State Food and Drug Administration may organize the Expert Committee on Medical Device Classification to formulate and adjust the catalogue of medical devices.
Article 10 These rules shall come into force on January 1, 2016. The Medical Device Classification Rules (formerly the State Drug Administration Order No. 15) promulgated on April 5, 2000 shall be repealed at the same time.