What is the Medical Device Classification Catalog?

<> is that the State Food and Drug Administration classifies registered devices in order to manage medical devices, and there are a total of 22 categories.

1. Medical suture needle (without thread).

2. Basic surgical knives, scalpel handles and blades, skin knife knives, wart peeling knives, lancets, shovel knives, razors, dandruff scrapers, pick knives, sharp knives, pedicure knives, manicure knives, scalpels

3. Scissors for basic surgery, general surgical scissors, tissue scissors, comprehensive tissue scissors, suture scissors, plaster scissors, dissecting scissors, gauze bandage scissors, and educational surgical scissors

4. Basic surgical forceps ordinary hemostats, small blood vessel hemostats, mosquito hemostats, tissue forceps, cemented carbide insert needle forceps, ordinary needle forceps, wound and seam removal forceps, ** rolling forceps, bullet forceps, gauze peeling forceps, sponge forceps, towel forceps, leather tube forceps, instrument forceps

5. Forceps for basic surgery, small vessel forceps, non-injury forceps, tissue forceps, plastic forceps, needle-holding forceps, health care forceps (simple forceps), plucking forceps, towel forceps, dressing forceps, dissection forceps, hemostatic clips

6. Needles for basic surgery, hook aneurysm needles, probes, hair pushing needles, hair grafting needles, pick needles, straight-pointed needles for teaching, vein hooks, wound hooks, flat hooks, double-ended hooks, ** hooks, dissecting hooks

7. Other basic surgical instruments: blade holder, illuminated suction head, acne extractor, blackhead acne extruder, curette, curette, scrape detector, inspection ruler, tissue driller, opener, cotton roll, reusable biopsy, preoperative limb disinfection lifting trolley, shaping needle, Y-connector, torsioner.

The classification of medical equipment is mainly as follows:

1.Classified by risk level.

The risk level is divided into three categories, according to which the first, second and third categories are marked. The first type is the medical equipment that is commonly used by doctors and has high routine and safety. The second category refers to machinery that has a certain risk and must be supervised and controlled by a special person.

The third category refers to the equipment used to maintain the patient's life, most of which need to enter the human body, the hidden risk is higher, and the machine needs to be watched at all times compared to the second category.

2.Functional classification.

This classification is relatively simple, medical machinery mainly plays a role in diagnosis, ** two major roles, so it is also divided into diagnostic machinery and ** machinery, our common thermometer is diagnostic machinery, more detailed classification, he should be divided into physical diagnosis machinery. Imaging machines include B-ultrasound, magnetic resonance, etc. In addition, ECG is an electrophysiological mechanic.

**The signs of action are divided into ordinary, auxiliary, and radiation. The ventilator is a typical auxiliary machine, the gamma knife belongs to the radiological machine, and the endoscope belongs to the ordinary machine.

3.Classification of active and passive machinery.

Active and passive here can be understood as whether it is plugged in or not. What is not driven by energy belongs to passive machinery, on the contrary, it is active machinery. On the basis of passive and active, it is divided into non-contact human body and contact human body machinery, through the literal meaning, we can understand that it is distinguished according to whether it enters the human body, and is divided into four sub-categories: passive non-contact human body equipment, passive contact human body equipment, active non-contact human body equipment, and active contact human body equipment.

The needle used in the infusion is a passive contact with the human body, and the machinery used in people's rehabilitation is a passive non-contact human body machinery. Devices implanted in the human body are active contact with human body machinery, and the electrocardiogram above is an active non-contact human device.

Send a ** to you, check it yourself.

In order to implement the relevant requirements of the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") for the classification management of medical devices, solidly promote the work related to the reform of the medical device review and approval system, and further consolidate the foundation of the classification management of medical devices, the State Food and Drug Administration (hereinafter referred to as the General Administration) launched the revision of the "Medical Device Classification Catalog" in July 2015 according to the overall deployment of the reform of medical device classification management.

Three categories. Class I medical devices refer to medical devices that are sufficient to ensure their safety and effectiveness through routine management. According to the provisions of Article 5 of the Regulations on the Supervision and Administration of Medical Devices issued by the state, the state will implement classified management of medical devices.

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray machine, B-ultrasound, microscope, biochemical instrument, etc., all belong to the second class of medical devices.

The state has a strict classification of medical devices, and the three types of medical devices are the highest level of medical devices, and they are also medical devices that must be strictly controlled, which refer to medical devices implanted in the human body to support and maintain life, which are potentially dangerous to the human body, and must be strictly controlled for their safety and effectiveness.

What is a medical deviceA medical device is an instrument, device, appliance, material, or other item used on the human body, either alone or in combination, including required software. The purpose of the use of these articles is to diagnose, monitor, alleviate or compensate for human diseases, disabilities, as well as the study of pregnancy control, anatomical or physiological processes, etc., and their effects on the human body are not obtained by pharmacological, immunological or metabolic means, but may involve these means and play a certain auxiliary role.

Medical Device Classification CatalogAccording to the Regulations on the Administration of Medical Devices, China divides medical devices into three categories:

Category 1: Medical devices that are sufficient to ensure their safety and effectiveness through routine management, such as ordinary surgical scalpels, scissors, dressings, etc.

Category II: Medical devices whose safety and effectiveness should be controlled, such as medical suture needles.

The third category: medical devices implanted in the human body, used to support and maintain life, potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled, such as various syringes, infusion sets, pacemakers, artificial heart valves, artificial joints, vascular stents, etc.

Medical Devices:

Summary. In order to implement the "Regulations on the Supervision and Administration of Medical Devices" and the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa 2015 No. 44), the State Food and Drug Administration issued the "Classification Catalogue of Medical Devices" (hereinafter referred to as the new "Classification Catalogue") on August 31, 2017, which will come into force on August 1, 2018. On March 22, 2022, the State Food and Drug Administration issued an announcement on adjusting part of the content of the "Classification Catalogue of Medical Devices", adjusting the content of the "Classification Catalogue of Medical Devices" for 10 medical device products such as 02-15-14 clamp devices.

The classification of medical devices is up-to-date.

Hello kiss Now answer your questions for you The classification catalog of medical devices is the latest, I send it to you in the form of ** Ha kiss

In order to implement the "Regulations on the Supervision and Administration of Medical Devices" and the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa 2015 No. 44), the State Food and Drug Administration issued the "Classification Catalogue of Medical Devices" (hereinafter referred to as the new "Classification Catalogue") on August 31, 2017, which will come into force on August 1, 2018. On March 22, 2022, the State Food and Drug Administration issued an announcement on adjusting part of the content of the "Classification Catalogue of Medical Devices", adjusting the content of the "Classification Catalogue of Medical Devices" for 10 medical device products such as 02-15-14 clamp devices.

What is 6848.

Dear, I'll send it to you with **

Is it true that the insurance company says that the VAMF3030C150TE is a prosthesis?

The intended use of the VAMF3030C150TE Thoracic Aortic Stent Graft System is to isolate the aneurysm cavity of the thoracic aortic aneurysm or close the dissection rupture opening, restore normal blood flow in the aortic cavity, and reduce the risk of ruptured thoracic aortic aneurysm or aortic dissection.

Is a heart stent a prosthesis?

Kiss does not belong. A heart stent is a metal object that is cast into a metal mesh structure through laser engraving or one-time molding, presenting a barrel shape.

Prosthesis, medically known as a prosthesis, is a medical device that replaces a limb, organ or tissue in the human body. Cardiac stents are not in this definition.

Why does the medical insurance company not pay a claim?

Dear, it may be that the insurance you purchased does not cover it, so the insurance company will not pay the claim. It is recommended that you take a closer look at the insurance contract, or call the insurance company's ** customer service directly to explain your specific situation.

Is it right for the insurance company to take the 17-year catalog? Is there a latest version.

Dear kiss, what I sent you is the latest version of the 17-year-old is OK, but there are only some changes later, which have nothing to do with you, mainly about medical aesthetics.

1. The classification of medical devices specifically refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management. Such as scalpel handles and blades, scalpels, surgical scissors, hemostats, all kinds of tweezers, needles, probes, hair pushing needles, hair planting needles, needle picking, teaching straight needles, retractors, blade holders, anesthesia masks, anesthetic openers, Zhaoqin trembling suction heads, acne extractors, all kinds of curettes, inspection rulers, tissue drillers, openers, cotton rolls and medical polymer materials and products interventional equipment.

2. Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray filmmaker, B-ultrasound, microscope, biochemical instrument and other friendly potatoes belong to the second class of medical devices.

3. The third class of medical devices refers to medical devices implanted in the human body, used to support and maintain life, potentially dangerous to the human body, and must be strictly controlled for their safety and effectiveness, such as implantable cardiac pacemakers, extracorporeal shock wave lithotripsy machines, invasive patient monitoring systems, intraocular lenses, invasive endoscopes, ultrasound scalpels, color ultrasound imaging equipment, laser surgical equipment, high-frequency electric knife, microwave instruments, medical magnetic resonance imaging equipment, X-ray equipment, X-ray machines above 200mA, and medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valve, artificial kidney, respiratory anesthesia equipment, disposable sterile syringe, disposable infusion set, blood transfusion set, CT equipment, etc.

4. Classification basis: the national suspect losers implement classified management of medical devices according to the degree of risk.