What about medical products. List of medical products

Instructions for searching for species in the nomenclatural classification medical devices by type

The nomenclature classification of medical devices by type (hereinafter referred to as the nomenclature classification) was approved by order of the Ministry of Health Russian Federation dated June 6, 2012 No. 4n "On approval of the nomenclature classification of medical devices".

The nomenclature classification is placed in in electronic format on the official website of the Federal Service for Surveillance in Healthcare in the information and telecommunications network "Internet".

The nomenclature classification contains:

Numerical designation of the type of medical product - a six-digit identification unique record number presented on the website in the first column of the table (column "Code"),

Name of the type of medical device (column "Name"),

Description of the type of medical device (column "Description").

The type name is not a standardized name for a specific medical device, but defines a type or species group, which is a collection of products that have the same or similar purpose and device (design).

The search for a species is carried out primarily by name. To clarify the attribution, a search is used for the description of the type, which contains a description of the properties and classification features of the medical device.

It is possible to search for a species in the nomenclature classification in the following ways:

The search for a word or part of a word in the name of a species is performed by placing the word or part of it in the name search string.

The line "Advanced search" allows you to navigate:

By type code;

By a word or part of a word in the species description;

By the word or part of the word in the title of the section.

On the left side of the page there is a list of sections and subsections, which allows you to select the types contained in this section (subsection). One view can belong to several sections (subsections). If you cannot find a view by keyword, it is recommended that you carefully review the views included in the corresponding section. This allows you to pick up additional keywords to search for the species.

Simultaneous use of search by name and description, or simultaneous search by name and selection of the appropriate section (subsection) allows you to narrow down the search of the desired type.

Search example.

Product name: Cobalt-chromium coronary stents.

Step 1.

Enter the word "stent" in the search bar by name. In the table, 174 records of types containing words that include this combination of letters are selected.

Step 2

To narrow the search, you can simultaneously enter a part of the word "coronary" in the "Advanced search" in the "Description" line. 14 records selected, 6 of them various kinds(some species are repeated, as they belong to several subsections).

Step 3

Viewing the displayed views allows you to select the desired view:

218190 "Stent for coronary arteries bare metal."

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Antonov Vladimir Stanislavovich
Assistant to the General Director of the Federal State Budgetary Institution "TsMIKEE" of Roszdravnadzor, Ph.D.

What are the criteria for classifying a device as a medical product?
- A legally significant definition of a medical device is formulated in the Federal Law No. 323-FZ "On the Basics of Protecting the Health of Citizens in the Russian Federation", Art. 38, p. 1 "Medical products".

"Medical devices are any instruments, devices, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, restoring, replacing, changing the anatomical structure or physiological functions organism, prevention or termination of pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body. Medical devices can be recognized as interchangeable if they are comparable in terms of functionality, quality and technical characteristics and are capable of replacing each other.

So, the product can be used jointly or separately (not always, if the product is not independent, it is not medical). It may not be independent in application, but relate to medical.

An important point is the criterion of purpose: for diagnosis, treatment, prevention, medical rehabilitation, monitoring the state of the human body, conducting medical research.

What is the sequence in which the criteria are applied to decide if a device is medical?
— First- mechanism of action. This paragraph immediately distinguishes between the product and the medicinal product. The main purpose of a medical device (hereinafter referred to as MI) should not be realized through pharmacological, genetic, immunological and metabolic actions, however, such methods can support the main purpose of MI. It is important what is the main mechanism of action.

Second- purpose, which refers to this concept. The applicant does not simply have to declare that he intends the device for medical purposes. The product must objectively have those properties and characteristics that affect its ability to act as intended for the stated medical purposes. In addition to the objective presence of such properties, it is necessary that these properties be documented and reflected in the technical specifications, operational documentation, and instructions for use. If the properties are objectively present, but they are not identified, not standardized, not specified, this casts doubt on whether the product is medical.

Since the purpose of the product, which is given to it by its manufacturer, plays an important role, the applicant must take such a claim item in the technical documentation very seriously. The description of the medical device should reflect that it is intended for medical purposes, and those technical aspects and properties that actually support its medical purpose should be indicated.

DO NOT GO THE EASY WAY

The Roszdravnadzor website hosts the Nomenclature Classification of Medical Devices by Type, the database of which contains more than 20,000 types. It is often convenient for the applicant to use this classifier to determine whether a device is medical: he finds a similar definition and decides that his device is medical. I emphasize that this approach is wrong. If you carefully read the norm of the law, then it states that MI is divided into types. First you need to determine whether this is a medical product, and then classify it, and not vice versa, because the types are not formulated in the form and in the exhaustive form that would allow the product to be classified as medical. For example, we find in the nomenclature classifier the type "hematological analyzer". We look at the technical details, and there is an indication "for veterinary medicine."

Although it seems that the name of MI is quite exhaustive, there is a detailed description and medical purposes are defined, questions nevertheless arise.

FINE LINES

There are many borderline cases where the criteria are difficult to apply.

Let us consider an example of distinctions between groups of similar concepts, when nuances allow or do not allow a product to be classified as medical.

Medical devices and medicines. What are the limits? "Patch containing a drug." Is it a medical device?

In this case, we must turn to the definition, which refers us to the mechanism of action. What is an appointment? If the purpose of the plaster is to close the wound and protect it from external influences, and at the same time the product may contain a bactericidal agent, then such a product is classified as medical.

Its main action is not pharmacological, but the bactericide present in the composition supports the main purpose.

But there are patches, the purpose of which is to deliver the drug to the human body. Despite the fact that this is a product in appearance, its purpose is realized in a pharmacological way, which means that it is a drug.

Another area of differentiation is medical and non-medical products.

The name of the product does not always indicate the only criterion for referring to MI. Its purpose is more important. For example, a simulator may be designed to restore body functions, then it is a medical product.

But there is a large number of simulators that are not intended for medical purposes, which are mentioned in the definition.

A separate case is software. With him, too, there are problems when classifying the product as a medical one. Here we are talking about the so-called independent software. This area is new in terms of regulation. A special group is working to put things in order in this area, to develop common approaches and criteria. There are many rules and standards that govern software, incl. they are also used for those software products that are intended for medical purposes.

Let me remind you that the documents should not just state that the operating system is intended for medical devices, it really should have properties and characteristics that justify the purpose. If not, then the product cannot be classified as MI.

DISPUTE POINTS

In cases of MI for diagnosis invitro questions also arise. One of the most acute is the distinction whether a set of test systems for the determination of any specific analytes is a medical product. The difficulty arises because the product itself often looks like a medical one: packaging, instructions for use. But at the same time, you can notice that in the primary documentation of the manufacturer there is an indication "for scientific research only". This means that the product is not intended for medical purposes and the information it provides is not scientifically and clinically sound enough to apply to a patient. Often, when such a product is submitted for registration, it is found that the product is not intended for diagnostics. invitro but only for scientific research.

There are situations when it is really difficult to determine whether a particular product belongs to a medical product, either due to the vagueness of the purpose, or (most often) the uncertainty of the mechanism of action. In such cases, the issue is considered at a meeting of a special commission in Roszdravnadzor with the involvement of qualified specialists to make the most objective decision.

Based on the materials of the seminar of Roszdravnadzor "On the procedure for preparing and processing documents for state registration medical products"

transcript

1 The program of state guarantees for the provision of citizens of the Russian Federation with free medical care on the territory of the Republic of Tatarstan for 2012 The list of medical devices required for the provision of inpatient medical care in the State Autonomous Institution "Central City clinical Hospital 18" Kazan Absorbent, adsorbent, sorbent, enterosorbent, hemosorbent, biomaterial Graduated jar Sputum collection jar Polymer jar baby food Paper for compresses Cotton wool Ear funnel Electrode gel Anesthetic gel Rubber, thermochemical heating pad, etc. Hemostatic tourniquet Arterial and venous needle Atraumatic surgical needle Laryngeal needle Blood collection needle Blood transfusion needle Heart puncture needle Pneumothorax needle Hypodermic injection needle vaccination Needle for puncture of the posterior fornix of the vagina Needle for puncture and drainage of the maxillary (maxillary) cavity Needle for puncture subclavian vein Needle for puncture intravascular introduction of conductors and catheters Needle for puncture biopsy Needle for endoscopy and laparoscopy Needle for epidural anesthesia Needle and set for spinal puncture Insulin needle Single use injection needle Ligature needle Spinal needle (instruments) Dental anesthesia needle

2 Fistula needle Surgical needle Ligature needle Needle holder for atraumatic needles General surgical needle holder Vascular needle holder Metal needle case blood pressure Products for reconstructive surgery Treatment and prophylactic products for personal hygiene Disposable products for ostomy patients Individual dressing products Connecting polymer products Sterilization process indicator Surgical instruments for minimally invasive interventions Oral irrigator Kalopriemnik Medical tuning fork Cannula Intravenous and umbilical Cannula for suprapubic urine drainage Cannula for maxillary washing (maxillary) sinuses Transitional cannula Ear cannula for washing the attic Medical dropper Capillary for clinical research Hematological cassette Catheter (probe) for suction and drainage Rectal catheter (probe) Catheter (stent) ureteral Catheter (stent) radiopaque (visceral, spinal, cerebral) Catheter (stent) radiopaque ureteral, urological Catheter (stent) silicone, ventricular catheter Intravenous catheter peripheral, intravascular single use Small vein infusion catheter (butterfly needle) Gastric catheter Metal catheter Nelaton catheter for drainage Bladder Nasal catheter (nasopharyngeal) (otorhinolaryngological) Pezzer catheter self-retaining large-headed latex catheter Subclavian catheter Latex polymeric catheter Thoracic catheter Tracheobronchial catheter for suctioning mucus (set) Female urethral catheter Male urethral catheter Ear catheter Foley catheter for bladder drainage

3 Polymeric endobronchial and endotracheal catheter Epidural catheter Catheter, tube, line for anesthesiology Drainage catheter Oilcloth underlay Medical adhesive Clamp for blood vessels Clamp holder for blood vessels Clip-blepharostat Clip holder Laparoscopic clips Fixing clips Massage mat Dielectric rubber mat Conicotome (device with a needle) Connector for intravenous infusions Cooling container (hypothermic bag) Working container and equipment for working containers Thermal insulating container for infusion solutions Inter-body transport container Conchotom Curved forceps Straight forceps Sterilization box (bix) for storing sterile instruments and materials decapitation hook for extraction foreign bodies from the ear Hook for insulation nerve trunks Hook for rhinoplasty (for pulling back the wings of the nose) Hook for the zygomatic arch Hook for removing foreign bodies and polyps Hook for removing foreign bodies from the nose Hook sharp Hook lamellar Farabeuf Hook bladder Tracheotomy Hook Surgical serrated Hook-coagulator Dahlgren Nippers Nippers for the first rib Curette Curette for obstetrics, gynecology and for removal of the fetal egg and placental tissue Curette for laryngeal and nasal Blade holder Surgical blades

4 Blades for scalpels Adhesive plasters Measuring tape (ruler) Ligature Gynecological spoon Spoon for microoperations on the larynx Spoon for paranasal sinuses Removal spoon gallstones Bone spoon Curette spoon Medical spoon Medical spoon for taking scrapings from the rectal mucosa Medical spoon for scraping fistulas Ear spoon Kidney-shaped tray Medical magnifier Manual magnifier Cuff for measuring blood pressure Medical gauze Protective mask Anesthesia mask, breathing mask Surgical mask Material for bone tissue regeneration Suture material (catgut) Suture material (surgical threads) Polypropylene monofilament suture material Suture silk material Consumable materials for taking and storing blood samples Packing materials Bag (container) for collecting urine Microshower for washing the maxillary and maxillary sinus Urinary bag Urinary bag for precise measurement Set for venosection Knife (needle) paracentesis bayonet-shaped Knife amputation Knife laryngeal Knife for gypsum Knife for operations in the oral cavity and nose Knife for cutting plaster bandages stricture Anatomical scissors Ophthalmic, intraocular scissors Horizontally curved scissors Laparoscopy scissors Metal scissors

5 Nail scissors Scissors for otorhinolaryngology Scissors for dressings Scissors for resection and coagulation Scissors for sinusotomy Curved scissors Scissors for rectoscope for rectal biopsy Medical scissors Microsurgical scissors Pointed scissors Flat curved scissors Straight scissors Rhinoscopic scissors Scissors with one sharp end straight Sanitary scissors Vascular scissors Blunt-pointed scissors Ear scissors Surgical scissors Vertically curved surgical scissors Surgical scissors for dissection of soft tissues in deep cavities Endoscopic scissors Nasal lift Oliva for blowing the nose and auditory tubes Disinfectant sprayer X-ray protective diaper Medical gloves X-ray protective gloves Surgical gloves Polyp loop Anatomical tweezers Gynecological tweezers , ophthalmic tweezers for applying and removing metal brackets tweezers serrated-toed tweezers medical tweezers plate tweezers tweezers for electrocoagulation Vascular tweezers Technical tweezers Urological tweezers Ear tweezers Surgical tweezers Spoon tweezers for dispensing tablets Eye pipette (ophthalmic) Pipette for hemoglobinometer glass Capillary pipette (Pasteur) Plasma filter Film for surgical operations Film for surgical treatment hernia Film x-ray medical

6 Headrest X-ray protective diaper panties Drinking cup Wound cover Strip, indicator plate for express analysis of urine Condom Test tube and microtube Stopper for catheters Sampler for determination of bacterial air pollution Cardiac wire-electrode Conductor for catheter insertion Conductor for tubes (mandrin) Prosthesis (endoprosthesis) bile ducts Prosthesis (endoprosthesis) of blood vessels (xenoprostheses, endoprostheses) Prosthesis (endoprosthesis) of the trachea and larynx Rubber bladder for ice Reagents and consumables for bacteriological studies Reagents, reagents for biochemical research Reagents, reagents for diagnostics infectious diseases Reagents, reagents for immunological studies Reagents, reagents for the study of hemostasis Reagents, reagents for radioimmunoassays Reagents, reagents for serological studies Reagents, reagents, materials for hematological research Reagents, reagents, solutions, preparations for clinical laboratory research Reagents for X-ray film processing Collection of aspirate gynecological Scalpel abdominal Scalpel ophthalmological Scalpel pointed general surgical (microsurgical) Scalpel surgical Staples for suturing wounds Saliva ejector Nipple Douche Medical Means for verification and testing of analyzers of erythrocyte aggregation Means for surgery: dressings, napkins, films Personal protective equipment for medical staff when working with infectious material Means of transportation Dressings (gauze, bandages, bags, dressings) Dressings of the plaster type Fixing and compression dressings, bandages elastic, rubber Sanitary and hygienic means Disinfectant Portable sanitary and hygienic means Radiopaque agent for the gastrointestinal tract Beaker for disinfection of instruments Measuring glass Beaker for biopsy material Cover and slide glass

7 Bedpan Serum for KDL Basin kidney-shaped Disinfectant swabs Packing containers Test strips for urinalysis Test system, kit, strips Test system, strips, plates for biochemical research purulent cavities drainage tube endotracheal tube Medical rubber tube, PVC Optical tube for endoscopes Rectal, vaginal tube X-ray tube Tracheal, endotracheal, tracheostomy, tracheotomy tubes, a set of tubes and accessories Device for intravenous infusions Device for enteral nutrition Clamp Air filter Filter for blood products, hemofilter Medical film Tsapki Watch hourglass procedural with a sound signal Petri dish Case-bag for a corpse Cotton or gauze balls Woyacek's awl Gynecological spatula Histological spatula Eye spatula Tongue spatula Laryngological spatula Syringe for intralaryngeal infusions Syringe for intrauterine infusions Syringe for disinfection and sterilization of root canals Syringe for washing cavities with accessories Syringe for rectal infusions Insulin syringe for single use Medical syringe and injection devices for multiple use Medical injection syringe for single use Brush (ruff) for endoscopes Obstetric forceps Biopsy forceps

8 Hemorrhoidal forceps Gynecological forceps Laryngeal forceps Dissector forceps Forceps for operations on the nasal septum and paranasal sinuses Forceps for plugging the ear, throat and nose Forceps for papilloma removal Forceps for removal of the fetal egg Forceps for installing an artificial stirrup Forceps for non-selective selection Crazing forceps The instrument to the cystoscope forceps to the endoscopes of the forceps intestinal forceps, the uterine twin-toothed three-toothed nasal forceps, the nasal forceps single-toothed for pulling the uterus (bullet) ophthalmic forceps Polyplane pinching forceps Early forceps. Small-in-wakes. catheter) to remove stones

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