The second article of this rule is used to guide the development of medical device classification catalog and determine the management category of new medical devices.
Article 3
The meaning of the relevant terms in these rules is:
(a) the intended purpose
refers to the product specification, labeling or promotional materials contained in the use of medical devices should be achieved.
(ii) passive medical devices
Medical devices that do not rely on electrical or other energy sources, but can perform their functions through energy generated by the human body or gravity.
(C) Active medical devices
Any medical device that relies on electrical or other energy sources, other than energy generated directly by the human body or gravity, to perform its function.
(D) invasive devices
With the help of surgery all or part of the body through the body surface invasion of the human body, contact with the body tissues, the blood circulation system, the central nervous system and other parts of the medical device, including interventional surgery in the use of the device, one-time use of sterile surgical instruments and temporary or short-term stay in the body of the device. Invasive devices in this rule do not include reused surgical instruments.
(E) reusable surgical instruments
Used in surgery for the process of cutting, cutting, drilling, sawing, grasping, scraping, pincer, pumping, clamping, etc., not connected to any active medical device, 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 the cavity (mouth), or for the replacement of the human epithelial surface or the surface of the eye, and at the end of the surgical process to remain in the body for 30 days (including) or more or by the body to be absorbed by the medical device.
(VII) contact with the human body devices
Directly or indirectly in contact with the patient or the ability to enter the patient's body medical devices.
(H) the use of time limits
1. Continuous use of time: the medical device according to the intended purpose, the actual duration of the role of the uninterrupted;
2. Temporary: the expected duration of continuous use of medical devices in less than 24 hours;
3. Short-term: the expected duration of continuous use of medical devices in 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 (inclusive).
(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 acting on the human body caused by the destruction of the integrity of tissue structure or dysfunction.
(xii) Tissue
The body's internal tissues, including bone, dental pulp or dentin, excluding the circulatory system and the central nervous system.
(xiii) Circulatory system
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 own intended purpose, and runs on a general-purpose computing platform.
(xvi) Medical devices with metrological test functions
Medical devices used for the determination of physiological, pathological or anatomical parameters, or the quantitative determination of energy or substances entering or leaving the human body, where the results of the measurements need to be accurately quantified and where the accuracy of such results would have a significant impact on the health and safety of the patient.
(xvii) Chronic wounds
Long-standing non-healing wounds formed by various causes, such as venous ulcers, arterial ulcers, diabetic ulcers, traumatic ulcers, and pressure ulcers.
Article IV of the 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.
The degree of risk of medical devices should be based on the intended purpose of the medical device, through the structural features, the form of use, the use of the state, whether contact with the human body and other factors.
Article 5 based on 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, is 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 devices and non-contact human body devices.
(C) according to the 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, medical dressings, invasive devices, reuse surgical instruments, implantable 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 the human body devices: energy therapy devices, diagnostic and monitoring devices, liquid delivery devices, ionizing radiation devices, implantable devices, other active contact with the human body devices.
Active non-contact human devices: clinical testing instruments and equipment, independent software, medical equipment sterilization equipment, other active non-contact human devices.
(D) according to the different structural features, whether contact with the human body and the form of use, the use of medical devices or its impact includes the following situations:
Non-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 (mouth), traumas or tissues, the blood circulatory system or the central nervous system. central nervous system.
Passive non-contact human body devices: according to the degree of influence on the medical effect is divided into basic non-influence, slight influence, important influence.
Active contact with the human body device: according to the degree of damage that may be caused by the 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 VI of the classification of medical devices should be based on the medical device classification judgment table (see Annex) for classification judgment. The following circumstances, should also be combined with the following principles of classification:
(a) If the same medical device applies to two or more classifications, should be taken to 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 medical devices.
(ii) can be used as an accessory medical device, its classification should be comprehensive consideration of the accessory to the supporting body of the impact of medical device safety, effectiveness; 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) monitoring 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 role of medical devices to the main combination of medicinal products, in accordance with the management of Class III medical devices.
(E) can be absorbed by the body of medical devices, in accordance with the third class of medical devices management.
(F) have an important impact on the medical effects of active contact with the human body devices, in accordance with the third class of medical devices management.
(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 the tissues below it for damaged wounds, used for chronic wounds, or can be absorbed by the body in whole or in part.
(viii) Medical devices supplied in sterile form shall be classified no lower than Class II.
(ix) by pulling, bracing, twisting, pressure grip, bending and other modes of action, the active application of sustained force on the human body, can be dynamically adjusted to the fixed position of the limbs of the orthopedic devices (excluding only fixed, supportive role of the medical device, nor with the surgical operation for temporary orthopedic medical devices or post-surgical or other treatments for the orthopedic limbs of the medical device), its Classification shall be not less than Class II.
(J) medical devices with measurement and testing functions, its classification should not be lower than Class II.
(xi) If the intended purpose of the medical device is clearly for the treatment of a disease, its classification should not be lower than Class II.
(xii) Passive reusable surgical instruments used to perform surgical operations such as clamping, cutting tissue or stone removal under endoscopy are managed in accordance with Class II medical devices.
Article VII in vitro diagnostic reagents are categorized in accordance with relevant regulations.
Article VIII of the State Food and Drug Administration in accordance with the production, operation and use of medical devices, medical devices in a timely manner to analyze and evaluate the risk of changes in the classification of medical devices catalog adjustment.
Article IX of the State Food and Drug Administration can organize medical device classification expert committee to develop, adjust the medical device classification directory.
Article X of these rules shall come into force on January 1, 2016.
The Rules for the Classification of Medical Devices (former State Drug Administration Decree No. 15) published on April 5, 2000 shall be repealed at the same time.
How to classify common medical devices a. Classified according to the degree of risk of medical devices 1, Class I: low risk, the implementation of routine management can ensure its safety, effective medical devices. Such as scalpel handle and blade, skin blade knife, wart stripping knife, lancet, spatula, razor, dander scraper, pick knife, sharp knife, pedicure knife, manicure knife, scalpel and so on.
2, the second category: with moderate risk, need to strictly control the management to ensure its safety, effective medical devices. Such as general diagnostic instruments (thermometers, sphygmomanometers), physical therapy and rehabilitation equipment (magnetic therapy appliances), clinical testing and analysis instruments (home blood glucose analyzer and test strips), operating room, emergency room, diagnostic and treatment room equipment and appliances (medical oxygen generator, portable oxygen generator), medical hygiene materials and dressings (medical cotton, medical cotton, cotton, medical gauze), medical polymer materials and products (condoms, contraceptive caps), etc.
3, the third category: a higher risk, need to take special measures to strictly control the management to ensure its safety, effective medical devices. Such as single-use sterile medical devices (single-use sterile syringes, single-use infusion sets, single-use blood transfusion, single-use anesthesia puncture kits, single-use intravenous needles, single-use sterile injection needles, single-use plastic blood bags, single-use blood collectors, single-use burette-type transfusion), orthopedic implants, medical devices (surgical implants and joints.), medical devices (surgical implants and joints.), Single-use sterile medical devices, hearing aids, contact lenses and nursing fluids, in vitro diagnostic reagents, 6846 implantable materials and artificial organs, 6877 interventional devices excluded) and so on.
Second, according to the use of medical equipment classification 1, home health care equipment
Pain massage equipment, home health care self-testing equipment, blood pressure monitors, electronic thermometers, multi-function therapeutic instrument, laser therapeutic instrument, glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene and health supplies, home emergency treatment products; electric massage chairs/beds, massage rods, Massage Whacker, Massage Pillow, Massage Cushion, Massage Belt, Blood Circulation Machine, Foot Bath, Foot Massager, Handheld Massager, Massage Bathtub, Fat Dumping Belt, Therapeutic Instrument, Plantar Physiotherapy Instrument, Weight Loss Belt, Car Seat Cushion, Kneading Cushion, Massage Chair, Breast Enhancement Instrument, Cosmetology Massager and so on.
2, home medical rehabilitation equipment
Home cervical and lumbar traction device, traction chair, physical therapy equipment, sleep instrument, massage instrument, functional chairs, functional beds, supporters, medical inflatable air cushion; oxygen machine, decoctions, hearing aids and so on.
3, home care equipment
Family rehabilitation nursing aids, women's pregnancy and baby care products, home use of gas supply and delivery equipment; oxygen cylinders, oxygen bags, home emergency medicine kit, blood pressure meter, blood glucose meter, nursing beds, etc..
4, commonly used medical equipment in hospitals
Trauma disposal vehicles, operating beds, surgical lights, monitors, anesthesia machines, respiratory machines, blood cell analyzers, differentiation analyzers, enzyme markers, plate washer, urine analyzers, ultrasound (ultrasound, ultrasound, etc.), X-ray machines, nuclear magnetic *** vibration and so on.