Classification Rules for Medical Devices (Order No. 15 of China Food and Drug Administration)


Medical Device Classification Rules

Article 1 In order to regulate 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 formulation of medical device classification catalogues and the determination of new medical device management categories.

Article 3 The meaning of the relevant terms in these Rules is:

(I) intended purpose

Refers to the role that the use of medical devices should achieve as stated in the product instructions, labels or promotional materials.

(II) passive medical devices

Medical devices that do not rely on electricity or other energy sources, but can perform their functions through energy generated by the human body or gravity.

(III) active medical devices

Any medical device that relies on electricity or other energy sources, rather than energy generated directly by the human body or gravity, to perform its function.

(IV) invasive instruments

Medical devices that invade the human body through the body surface in whole or in part by means of surgery and contact with internal tissues, blood circulation system, central nervous system and other parts of the body, including devices 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 re-use of surgical instruments.

(V) reuse of surgical instruments

It is used for cutting, cutting, drilling, sawing, grasping, scraping, pliers, pumping, clamping and other processes during surgery. It is not connected to any active medical device and can be reused through certain processing.

(VI) Implantation Devices

Medical instruments that enter the human body or cavity (mouth) in whole or in part by surgery, or are used to replace the human epithelial surface or eye surface, and remain in the human body for more than 30 days (inclusive) or are absorbed by the human body after the operation.

(VII) contact with human instruments

A medical device that directly or indirectly contacts a patient or is capable of entering the patient's body.

(VIII) Use Time Limit

Continuous use time: the actual action time of medical devices according to the intended purpose and uninterrupted;

Temporary: The expected continuous use of medical devices is within 24 hours;

Short-term: The expected continuous use of medical devices is more than 24 hours (inclusive) and less than 30 days;

Long-term: The expected continuous use of medical devices is more than 30 days (inclusive).

(IX) skin

Undamaged skin surface.

(X) lumen (mouth)

Oral cavity, nasal cavity, esophagus, external auditory canal, rectum, vagina, urethra and other human natural cavity and permanent artificial opening.

(11) Trauma

Damage to the integrity or dysfunction of tissue structure caused by various injury factors acting on the human body.

(XII) Organization

Human body tissues, including bone, dental pulp, or dentin, excluding the blood circulatory 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 purposes and can accomplish its intended purpose without medical device hardware and runs on a general computing platform.

(xvi) Medical devices with metrological testing functions

Medical devices used to measure physiological, pathological, anatomical parameters, or to quantify energy or substances entering and leaving the human body require accurate quantification of the measurement results, and the accuracy of the results will have a significant impact on the health and safety of the patient.

(XVII) Chronic wound

Long-term non-healing wounds formed by various reasons, such as venous ulcers, arterial ulcers, diabetic ulcers, traumatic ulcers, pressure ulcers, etc.

Article 4 Medical devices are divided into the first category, the second category and the third category according to the risk level from low to high, and the management category.

The degree of risk of a medical device shall be comprehensively determined according to the intended purpose of the medical device, through factors such as structural features, forms of use, state of use, and contact with the human body.

Article 5 According to the factors affecting the risk degree of medical devices, medical devices can be divided into the following situations:

According to the different structural characteristics, (I) are divided into passive medical devices and active medical devices.

(II) according to whether contact with the human body, divided into contact with human body equipment and non-contact human body equipment.

(III) According to different structural characteristics and whether it is in contact with the human body, the use of medical devices includes:

Passive contact with human body devices: liquid delivery devices, blood and body fluid change devices, medical dressings, invasive devices, re-use surgical devices, implant devices, contraceptive and family planning devices, and other passive contact with human body devices.

Passive non-contact human body equipment: nursing equipment, medical equipment cleaning and disinfection equipment, other passive non-contact human body equipment.

Active contact devices: energy therapy devices, diagnostic monitoring devices, liquid delivery devices, ionizing radiation devices, implant devices, other active contact devices.

Active non-contact human instruments: clinical testing instruments and equipment, independent software, medical equipment disinfection and sterilization equipment, other active non-contact human instruments.

(IV) According to different structural features, whether it is in contact with the human body and the form of use, the use status of medical devices or their effects include the following situations:

Passive contact with human devices: according to the use of time limit is divided into temporary use, short-term use, long-term use; contact with the human body parts into skin or cavity (mouth), trauma or tissue, blood circulation system or central nervous system.

Passive non-contact human devices: according to the degree of impact on the medical effect is divided into basic non-impact, minor impact and important impact.

Active contact devices: according to the degree of possible damage caused by loss of control, they can be divided into minor damage, moderate damage and serious damage.

Active non-contact human devices: according to the degree of impact on the medical effect is divided into basic non-impact, minor impact and important impact.

Article 6 The classification of medical devices shall be determined according to the classification determination table for medical devices (see Annex). In the following cases, it should also be classified in conjunction with the following principles:

(I), if two or more classifications apply to the same medical device, the classification with the highest degree of risk shall be adopted; for a medical device package consisting of multiple medical devices, the classification shall be consistent with the medical device with the highest degree of risk in the package.

(II) medical devices that can be used as accessories, their classification shall comprehensively consider the impact of the accessories on the safety and effectiveness of the supporting main medical devices; if the accessories have important impact on the supporting main medical devices, the classification of the accessories shall not be lower than that of the supporting main medical devices.

The classification of medical devices (III) to monitor or affect the main functions of medical devices shall be consistent with the classification of the monitored and affected medical devices.

The (IV) of medical device combination products based on the role of medical devices shall be managed in accordance with the third category of medical devices.

(V) medical devices that can be absorbed by the human body are managed in accordance with Class III medical devices.

(VI) active contact devices that have an important impact on the medical effect shall be managed according to the third category of medical devices.

If (VII) medical dressings have the following conditions, they shall be managed according to the third category of medical devices, including: expected to have the function of preventing tissue or organ adhesion, as artificial skin, contacting the deep dermis or its following tissue damaged wounds, used for chronic wounds, or can be fully or partially absorbed by the human body.

(VIII) medical devices provided in sterile form, their classification shall not be lower than the second category.

(IX) orthopedic instruments that actively exert continuous force on the human body and can dynamically adjust the fixed position of limbs by pulling, distracting, twisting, holding, bending and other modes of action (not including medical instruments that only have fixing and supporting functions, nor medical instruments that cooperate with temporary orthopedic surgery or medical instruments that perform orthopedic limbs after surgery or other treatments), its classification should not be lower than the second category.

The classification of (X) medical devices with metrological testing function shall not be lower than the second category.

(11) If the intended purpose of a medical device is to be specifically used for 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 clamping, cutting tissues or taking stones under the endoscope shall be managed in accordance with the second category of medical instruments.

Article 7 In vitro diagnostic reagents shall be classified in accordance with the relevant provisions.

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 classified catalogue of medical devices.

Article 9 The State Food and Drug Administration may organize the medical device classification expert committee to formulate and adjust the medical device classification catalog.

Article 10 These Rules shall come into force as of January 1, 2016. The Rules for the Classification of Medical Devices promulgated on April 5, 2000 (Order No. 15 of the former State Drug Administration) shall be repealed simultaneously.

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