What is a medical pull level and what does it include?

Basic Surgical InstrumentsMicrosurgical Instruments.

Neurosurgical instruments, ophthalmic surgical instruments.

Otolaryngology Surgical InstrumentsOral Surgical Instruments.

Thoracic cardiovascular surgical instruments, abdominal surgical instruments.

Urology, anorectal surgical instruments, orthopedic (orthopedic) surgical instruments, obstetrics and gynecology surgical instruments, family planning surgical instruments.

Injection and puncture instruments, surgical instruments for burn (plastic) surgery.

General diagnostic equipment, medical electronic instruments and equipment.

Medical Optical Instruments, Instruments and Endoscopic Equipment, Medical Ultrasound Instruments and Related Equipment, Medical Laser Instruments and Equipment, Medical High-Frequency Instruments and Equipment.

Physics**and**equipmentTraditional Chinese medicine equipment.

Medical magnetic resonance equipment, medical X-ray equipment.

Medical X-ray Accessories and ComponentsMedical High Energy Ray Equipment.

Medical nuclide equipment, medical radiation protection equipment, devices.

Clinical laboratory analysis instruments, medical laboratory tests and basic equipment and appliances.

Cardiopulmonary bypass and blood processing equipment, implanted materials and artificial organs.

Operating room, emergency room, diagnosis and treatment room equipment and equipment, dental equipment and equipment, ward nursing equipment and equipment, disinfection and sterilization equipment and equipment.

Medical cold therapy, low temperature, refrigeration equipment and appliances, dental materials, medical hygiene materials and dressings, medical suture materials and adhesives.

Medical polymer materials and products interventional equipment.

The first type is medical devices with a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness. Such as: surgical instruments (knives, scissors, forceps, tweezers, hooks), scraping boards, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.

Surgical instruments are classified as Class I medical devices.

The first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management.

Please see the "Classification Catalogue of Medical Devices" issued by the State Food and Drug Administration

China medical equipment platform online collection of information: medical devices in the hospital are divided into: diagnostic back and ** two categories;

Diagnostic instruments include: physical diagnostic instruments (thermometers, blood pressure monitors, microscopes, audiometers, various physiological recorders, etc.), imaging (X-ray machines, CT scans, magnetic resonance, B-ultrasound, etc.), analytical instruments (various types of counters, biochemical, immunoassay instruments, etc.), electrophysiology (such as electrocardiogram machines, electroencephalogram machines, electromyography machines, etc.);

**Including: ordinary surgical instruments, light guide surgical instruments (fiber endoscope, laser machine, etc.), auxiliary surgical instruments (such as various anesthesia machines, ventilators, extracorporeal bypass, etc.), radiation machinery (such as deep X-ray machines, cobalt 60 machines, accelerators, gamma knife knives, various isotope machines, etc.), others: microwave, hyperbaric oxygen 、..

The necessary medical equipment in the hospital has different requirements according to each level.

It is divided into three categories: the first category refers to the medical devices that are sufficient to ensure their safety and effectiveness through routine management.

The second category refers to medical devices whose safety and effectiveness should be controlled.

The third category refers to implantation in the human body; used to support and sustain life; Medical devices that are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness.

According to the BAI risk level, the first type of risk DU is low and easy to control, such as the DAO class of gauze needles. The third category has higher risks and higher requirements for supervision that specializes in registration and post-marketing genera, such as pacemakers, anesthesia machines, ventilators, etc.

When registering and certifying, medical devices are classified according to the risk level, and the registration process for different categories of devices is different, and the specific category of your product belongs to depends on the documents of the Food and Drug Administration.

If you are doing CE certification, the products are also divided into Class I, IIA, IIB and III according to the risk level, depending on the MDD Directive 93 42 EEC Annex IX to determine which category your product belongs to according to the classification rules.

The first level is more difficult than the first, the class is easier to control, all are needles, the gauze class is slightly easier to control, and the medical microscope seems to belong to this category; It is difficult to control, such as large equipment CT and MRI.

First-level medical institutions refer to primary hospitals and health centers that provide prevention, medical treatment, health care and first-class services to communities with a certain population.

Its main function is to directly provide primary prevention to the population, manage patients with frequent and common diseases in the community, and make correct referrals for difficult and severe diseases, assist high-level hospitals to do a good job in intermediate or post-hospital services, and reasonably triage patients.