Production of medicines and medical products in accordance with GMP rules. Registration of medical devices (MD) in Roszdravnadzor. Obtaining a turnkey registration certificate Consumables - nondescript, but necessary
People have always treated medicine as something sacred, inaccessible, incomprehensible to ordinary people. Complicated diagnoses, the names of active ingredients in drugs - all this can easily confuse an ignorant person. Often in pharmacies there is also the inscription “List of“ Medical Devices ”, the meaning of which is not always clear. So, what is included in this list and how can its knowledge be useful to an ordinary buyer?
What it is?
Let's start with the fact that medical products include products made from glass, polymers, rubber, textiles and other materials, this also includes special reagents and control materials for them, as well as other consumables that are used in medicine. .
Most often, these are single-use items that do not need special maintenance. In the pharmaceutical market, products included in the list of “Medical Products” account for 20% of the total number of goods. Unfortunately, only a fifth of these products are not manufactured abroad.
Reagents, test strips and other pre-diagnostics
Let's move on to specific examples. The approved list begins with all kinds of reagents, among which you can find strips for measuring glucose levels, detecting drugs in the blood, and various devices for laboratory research (some types of acids, alkalis and other reagents). This group also includes indicators that help to test not only the patient, but also medical equipment (for example, a sterilization indicator).
Usually, goods from this group are not very accessible to the general population, since it is very problematic to use them at home. The most popular among "civilians" are test strips, which are used in glucometers. You can buy them without a prescription, however, you need to know the model of a particular glucometer.
Identification of dangerous diseases
The next large group that the approved list of medical products contains is serums that diagnose some dangerous diseases. This includes medicines for the determination of shigellosis, salmonellosis. There is also a set of basic antibiotics, with the help of which the sensitivity of microorganisms that cause the disease to certain drugs is determined. Such a measure can significantly reduce the likelihood of an error in prescribing an inappropriate medication.
Gloves, probes and urinals - list of consumables
Further, the list of medical products in 2016, and previous years, contains a number of items used as consumables. Here are gloves (from non-sterile, which are often used during examinations, to especially thin gloves that are used by neurosurgeons - the list includes a dozen different items used in different areas of medicine).
This also includes various types of ear, for feeding babies), urinals, oilcloths used in a variety of manipulations. Simply put, this group of products is probably one of the largest in this list.
Catheters, needles and syringes of all shapes and sizes
This is followed by catheters, needles and syringes - very unpleasant things, but still necessary. It is worth noting that the list of “Medical Products” contains several dozen types of catheters that differ not only in diameter, but also in their functions: there are urological, feeding, and intramuscular catheters, in other words, for any operation. As for needles, the variety here is just as great: in addition to the usual needles that are inserted into syringes for injections, there are needles for puncture, acupuncture, and surgical ones - the list of goods is also extensive. Syringes differ, like catheters, in their functions and sizes: from small insulin ones to special metal ones, in addition to which a whole range of different tubes is provided.
This group also includes systems for blood transfusion, without which it would be impossible to save a huge number of people.
Dressings, various dressings
We must not forget about the various devices for dressings, answering the question of what applies to medical products. The list includes many items, ranging from various types of cotton wool and adhesive plasters to special plaster bandages, which greatly facilitate the life of traumatologists. This also includes various napkins: sterile, impregnated with medicines, both anti-inflammatory and analgesics. Of course, bandages should not be excluded, which can also be included in this group. The list also includes wound healing dressings, and those that only close wounds and burns.
For manipulations and examinations
The list of "Medical Devices" will not be complete without a variety of devices used by physicians during examinations and during various manipulations. This includes masks, both surgical and oxygen, with and without analgesics. In the same group are surgical glasses, as well as glasses that protect the eyes from exposure to ultraviolet radiation. The huge group that appears in the list called "Others" includes both paper for taking an electrocardiogram and medical mirrors, which are so actively used by dentists and otolaryngologists.
Even such seemingly trifles as gels for ultrasound examination are included in this group. Simply put, this includes almost all consumables and medical instruments.
Used in necessary procedures and in-depth studies
The list of vital medical devices contains entire sets of tools and consumables used in various manipulations. These include procedures such as hemodialysis and peritoneal dialysis, studies using a gas chromatograph and a fluroimmunoanalyzer (during which the presence of drugs and narcotic substances in the patient's body is determined). All the necessary items, from needles to reagents, are in this group of the list.
Specialized Tools and Consumables
Further, the list of medicines, medical devices begins to be divided into specializations. There are materials for the provision of cardiac surgery (this includes electrodes, vascular prostheses, introducers - everything that doctors may need in an emergency). Another large group is anesthesiology and resuscitation: there are also sensors for heart rate monitors, tourniquets to stop bleeding, and artificial nutrition systems. The instruments and consumables used by surgeons deserve special attention: staplers, clips, clamps - everything that is necessary when performing even the simplest operations.
The latter category is also divided into several subgroups: neurosurgery that works with the brain (here, drainage systems, systems for fixing fractures, catheters are needed), thoracic surgery, specializing in chest organs (dozens of types of clamps, breathing support drugs, inhalers, oxygen bags) and some others. Traumatologists and orthopedists may need various pins and screws, metal plates to fix injured limbs, as well as plaster casts.
Films and developers, as well as tubes
The list of "Medical Products" includes a variety of tubes, incubation and drainage, venting and for consumables can also include flasks for reagents used in radiation therapy. This also includes films used in X-ray studies and fluorographic images, as well as developers and fixers that fix the image on these films.
Consumables - inconspicuous, but necessary
The last and most extensive group is consumables. This includes all those tools and objects that are used only once, and then either destroyed or undergo the most serious processing. Such products are spittoons, flasks, test tubes, cuvettes, pipettes, measuring cylinders, laboratory glasses - without them, medical diagnostics and treatment of patients would be impossible. Such sometimes imperceptible, but nevertheless necessary - the last category, which includes the list of medical devices and consumables.
Registration procedure
However, it is not easy for new manufacturers to enter the ranks of suppliers of products such as medical products. The list, registration certificates are approved and issued by the authorized executive body. All devices, preparations and materials must have such certificates. All registration requirements for new products are contained in the Fundamentals of Health Act. The drug, which is being prepared for release on the market, must pass numerous tests of efficacy and quality, as a result of which a large number of documents are filled out.
That is why registration is most often entrusted to authorized enterprises that already have experience in communicating with executive bodies and will be able to conduct not only the necessary research, but also prepare all the documents. It is also worth noting that every five years all drugs must be re-tested, which again confirms their quality and safety. So be sure that reagents, devices, tools and other medical products and consumables from the list approved by the highest government bodies are completely safe for health.
1. Medical products 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 of the body, preventing or terminating 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.
2. Medical devices are divided into classes depending on the potential risk of their use and into types in accordance with the nomenclature classification of medical devices. The nomenclature classification of medical devices is approved by the authorized federal executive body.
3. The circulation of medical devices includes technical tests, toxicological studies, clinical trials, examination of the quality, efficacy and safety of medical devices, their state registration, production, manufacture, import into the territory of the Russian Federation, export from the territory of the Russian Federation, conformity assessment, state control, storage, transportation, sale, installation, adjustment, use, operation, including maintenance provided for by the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer), as well as repair, disposal or destruction. The manufacturer (manufacturer) of a medical device develops technical and (or) operational documentation, in accordance with which the production, manufacture, storage, transportation, installation, adjustment, use, operation, including maintenance, as well as repair, disposal or destruction of medical equipment are carried out. products. Requirements for the content of the technical and operational documentation of the manufacturer (manufacturer) of a medical device are established by the authorized federal executive body.
4. On the territory of the Russian Federation, the circulation of medical devices registered in accordance with the procedure established by the Government of the Russian Federation and the federal executive body authorized by it is permitted.
5. Medical products that are manufactured on individual orders of patients, which are subject to special requirements for the appointment of medical professionals and are intended solely for personal use by a particular patient, as well as medical products intended for use on the territory of the international medical cluster or on the territories of innovative scientific and technological centers are not subject to state registration. These medical devices are not subject to the provisions of Part 3 of this Article, which provide for the development by the manufacturer (manufacturer) of the medical device of technical and (or) operational documentation.
(see text in previous edition)
6. The procedure for importing medical devices into the territory of the Russian Federation for the purpose of state registration is established by the authorized federal executive body.
7. Import into the territory of the Russian Federation and export from the territory of the Russian Federation of medical devices within the framework of doping control is carried out in the manner established by the Government of the Russian Federation.
8. For the purpose of state registration of medical devices, in the manner established by the authorized federal executive body, conformity assessment is carried out in the form of technical tests, toxicological studies, clinical trials and examination of the quality, efficiency and safety of medical devices, as well as tests in order to approve the type of measuring instruments (in relation to medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the authorized federal executive body).
9. For the state registration of medical devices and the examination of the quality of the effectiveness and safety of medical devices, a state fee is charged in accordance with the legislation of the Russian Federation on taxes and fees.
10. In accordance with the procedure established by the Government of the Russian Federation, the federal executive body authorized by it maintains the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, and places it on its official website on the Internet.
(see text in previous edition)
11. The following information shall be entered into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices:
(see text in previous edition)
1) name of the medical device;
2) the date of state registration of the medical device and its registration number, the validity period of the registration certificate;
3) the purpose of the medical device, established by the manufacturer;
4) type of medical device;
5) class of potential risk of using a medical device;
7) name and location of the organization - the applicant of the medical product;
8) name and location of the organization - manufacturer (manufacturer) of a medical device or surname, name and (if any) patronymic, place of residence of an individual entrepreneur - manufacturer (manufacturer) of a medical device;
(see text in previous edition)
9) address of the place of production or manufacture of the medical product;
10) information about interchangeable medical devices.
12. Counterfeit medical device - a medical device accompanied by false information about its characteristics and (or) manufacturer (manufacturer).
13. Poor-quality medical device - a medical device that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer) or, in its absence, the requirements of other regulatory documentation.
Medical factories are a large group of enterprises producing medical equipment and medical products. The medical industry is designed to provide all conditions for the provision of high-quality, high-tech medical care to Russian citizens, and from this point of view, it can be called one of the key industrial sectors of the state, determining the level of its social development.
All enterprises producing products for the needs of medicine can be divided into two groups:
1) Enterprises producing complex medical equipment, instruments and medical products:
- medical equipment factories;
- medical equipment factories;
- medical equipment factories;
- medical instrument factories.
2) Enterprises producing chemical-pharmaceutical and biomedical preparations and substances:
- pharmaceutical factories;
- pharmaceutical factories;
- pharmaceutical factories.
The production of medical equipment and other medical products is one of the most knowledge-intensive. A number of innovative technologies developed for use in military purposes, as a result of the conversion, become available for civilian use and are implemented in the creation of modern medical equipment.
The most demanded segments of the medical products market in the Russian market are represented by:
- equipment and products with a high degree of visualization (X-ray diagnostic equipment, devices for ultrasound diagnostics);
- equipment and products for cardiovascular surgery;
- equipment and products for urology and nephrology.
52% of all medical products manufactured in the country are in Moscow and St. Petersburg. The second place in terms of production of medical equipment in the country is held by enterprises of Tatarstan and the Nizhny Novgorod Region (Volga Federal District).
According to 2010 data, the Russian medical equipment market accounted for approximately 1.13% of the global medical products market. Nevertheless, the volume of exports of medical products and equipment manufactured by Russian enterprises is steadily increasing. The products of Russian medical plants are supplied not only to the nearest neighbors - Kazakhstan, Ukraine, Uzbekistan, but also to far-abroad countries - Germany and the USA.
In the domestic market, the main consumers of Russian medical equipment are healthcare institutions operating in the public sector.
In Russia, there are more than 600 factories producing pharmaceutical and biomedical products. More than half of all medicines produced in the country are manufactured at the 20 largest enterprises. The level of development of the pharmaceutical industry is very high, which allows the production of all currently known finished forms of medicines.
Pharmaceutical enterprises are actively moving to GMP standards that meet international requirements, thanks to which the competitiveness of Russian pharmaceutical products in the domestic and foreign markets is gradually increasing.
One of the main trends of recent years is the opening of factories in Russia by large foreign pharmaceutical corporations. Nevertheless, on the part of domestic manufacturers, there has been a desire to resume the production of previously produced substances, create new original high-tech substances and expand the range of manufactured drugs.
The first GMP rules were adopted in 1963 in the USA, then in Canada, Italy, England and 40 other countries. GMP rules are a general guide that establishes the organization of the production process and control, as well as containing minimum practical guidelines for modern correct production. On the basis of GMP rules, each country creates standards and documents that regulate the production of certain types of pharmaceutical products.
In Russia, GMP rules (“Rules for the organization of production and quality control of medicines” - RD 64-125-91) were first developed in 1991. In subsequent years, new GMP rules and international standards appeared. They include for the first time or develop new provisions, such as quality management, validation. By order of the Ministry of Health and the Ministry of Economy of the Russian Federation, OST 42-510-98 "Rules for the organization of production and quality control of medicines (GMP)" was introduced in stages, starting from July 1, 2000, and is mandatory for all organizations manufacturing drugs and medicinal products ( substances). The phased introduction of OST 42-510-98 will be carried out in full before March 31, 2005, and for enterprises producing substances - until December 31, 2008.
The concept of GMP is based on the understanding of the limited possibilities of quality control of drugs after their receipt in the conditions of laboratory testing. A significant disadvantage of assessing the quality of the final product is the conditionality of transferring the assessment of the test samples to the entire controlled series.
GMP rules are systematic and preventive. They are aimed at preventing errors and deviations by taking into account all factors that can affect the quality of the finished product from the very beginning until the end of the production cycle. The introduction of these rules is impossible without due attention to sanitation and personal hygiene at work, to technological and control documentation, without modern equipment.
In accordance with the GMP system, the entire production process must be checked, "validated", equipment "qualified", instrumentation "calibrated". Moreover, all these operations must be “documented”. GMP rules, contributing to the development of products that are homogeneous within batches and between batches, significantly increase the importance of selective analysis of finished products for all types of control, both at the manufacturing plant - output, and consumer - state.
Thus, GMP rules are aimed at reducing the risk inherent in pharmaceutical production, which cannot be eliminated only by controlling the quality of the final product.
The GMP standard (“Good Manufacturing Practice”, Good Manufacturing Practice) is a system of norms, rules and guidelines for the production of medicines, medical devices, diagnostic products, food products, food additives and active ingredients. In contrast to the quality control procedure by examining random samples of such products, which ensures the suitability for use only of these samples themselves (and, possibly, batches produced in the nearest time to this batch), the GMP standard reflects a holistic approach and regulates and evaluates the actual production parameters. and laboratory testing.
"Good Manufacturing Practices (GMP)"
This International Standard is an integral part of a quality assurance system that ensures that production and control are carried out in the enterprise in accordance with the requirements of the relevant documentation. Rules minimize the risk of manufacturing errors that cannot be eliminated or prevented by quality control of the finished product alone. The two most common types of errors are:
Cross-contamination;
Mixing and/or mixing of finished products.
The rules provide:
Clear regulation of all production processes and process control to confirm its suitability for the production of finished medicinal products of the required quality;
Validation of all stages of production that may affect the quality of products and all significant changes in it;
Provision of production with properly trained and qualified personnel, necessary premises, appropriate equipment and services, raw materials, auxiliary, packaging and marking materials of the required quality, as well as storage of raw materials and materials in appropriate conditions and proper transportation;
Availability of written clearly and unambiguously technological regulations and instructions for each specific production;
Training of personnel in the proper performance of technological operations;
Registration of all stages of production, confirming that all the operations required by the regulations have been completed, and the resulting products comply with the established requirements in terms of quantity and quality. All deviations must be carefully recorded and studied;
Storage of current production documentation (series reports, route maps, etc.), including documentation on the sale of the finished product, which makes it possible to trace the passage of each product series for a certain time, in an accessible form in a certain place;
Storage and distribution of the finished product in such a way as to minimize the risk of quality deterioration;
The procedure for the return, if necessary, of any batch of the finished medicinal product at the stage of sale or delivery, followed by an analysis of the reasons for the violation of its quality and to prevent the recurrence of identified deficiencies.
Quality control is part of the GMP Rules, which includes sampling, testing and issuing relevant documents that ensure that all the necessary tests have actually been carried out, the production process complied with the requirements of the regulations, and the finished product was sold only if its quality met ND requirements.
The quality control system (objects of control, operations, technical equipment, methods, etc.) is an integral part of the production process. Each pharmaceutical enterprise should have a quality control department (QCD) in its structure.
Production process
The main purpose of pharmaceutical production is the production of drugs and drug products. In this case, raw materials, auxiliary, packaging and marking materials are used. The most important part of the quality assurance system for finished products is proper documentation. It should be linked to all sections of the GMP rules and reflect their main requirements. The production process must be carried out in strict accordance with the technological regulations, which reflect the requirements of GMP rules, which ensures the proper quality of the finished product.
Importance is attached to the quality of raw materials. Pharmaceutical enterprises must have an approved RD for raw materials, as well as an enterprise standard for it. The latter includes: description of raw materials, reference to RD, indication of possible suppliers, volumes and terms of delivery, instructions for sampling and incoming control, quality requirements, proper storage conditions and precautions, expiration date or date of additional quality control. All these requirements are strictly observed and controlled.
The resulting raw material is subjected to input control according to ND, for which average samples are taken from each series. Only raw materials that comply with ND are issued for production, with the permission of the OKC. Samples are kept from each batch of raw materials in case of repeated analytical checks. Much attention is paid to preventing secondary contamination during the delivery of raw materials. All components included in non-sterile drugs are tested for microbial contamination, and those included in sterile drugs are also tested for sterility, if necessary, for pyrogenity and the absence of mechanical impurities.
The production process must strictly comply with the technological regulations and guarantee the release of drugs or drugs, the quality of which meets the requirements of ND. The conditions of the technological process should ensure its flow, consistency, safety and trouble-free operation of technological equipment, optimal loading. It is necessary to exclude or minimize the contact of personnel with raw materials, packaging material, the finished product in the process of receiving it. Strict documentation of all stages of the technological process is provided. Waste is processed. It is necessary to ensure maximum automation and computerization of technological processes, mechanization of loading and unloading operations. Particular attention is paid to the production of sterile drugs, which requires a special set of measures.
In the production process, step-by-step control is carried out. Is it carried out by employees of the workshop laboratory? regularly) and OCC (periodically). The purpose of stage-by-stage control is to prevent the release of a finished product that does not meet the requirements of ND. The control is carried out with the frequency of checks in relation to this product and production conditions in strict accordance with the current industry documents, technological regulations and written instructions.
In the course of stage-by-stage control, the following is checked: compliance with the requirements of the normative documents of the used raw materials, semi-finished products, auxiliary, packaging and other materials; sanitary condition of workshops, workplaces and equipment; performance of technological operations and observance of technological modes of operation. The results of the stage-by-stage control are reflected in the corresponding journals. In case of detection of deviations from the modes and norms of the technological process, it is necessary to identify the causes and take measures to eliminate them, which are also documented and entered into the dossier.
Great importance is attached to documentation in the production process. It must meet all production requirements, be carefully designed, compiled, tested and approved.
The main documents used in the production process: technological regulations, instructions, production records, analytical methods, quality specifications and other enterprise standards. The production process of each drug is described according to the requirements of special instructions, which must contain the following data: name, type of drug product and drug dosage; authenticity, quantity and quality of each type of raw material for all stages of production; description of operations for the production and storage of semi-products and FPP; theoretical output and allowable limits of the actual output of the finished product at different stages; description of methods of packaging and labeling of medicines; a description of the necessary control analyzes at each stage of production and the name of the departments exercising control.
Thus, the process of drug production at each stage is accompanied by quality control of raw materials, packaging, auxiliary and other materials, semi-finished products and the final product.
Validation and implementation of GMP rules
According to the new GMP rules, the main elements of validation are: assessment of the installation and performance of all process equipment (including computer systems); assessment of the conditions and parameters of the technological process and the permissible limit of possible deviation in its implementation; evaluation of analysis methods, preparation of protocols and a report certifying the technological process.
Validation should be carried out for each new technological process before its introduction into production, as well as for existing processes for the production of sterile drugs (validation of the technological process and equipment).
Re-validation (re-validation) is carried out in the following cases: changes in ND for FPP, raw materials, auxiliary, packaging and other materials; changes in technological documentation; replacement or repair of equipment; re-equipment of industrial premises, heating, ventilation and other auxiliary systems; detection of unregulated deviations in the technological process; scheduled validation in accordance with approved schedules.
The implementation of GMP rules is a means of achieving sustainable high product quality, a measure of proof of the reliability of the quality system. The concept in GMP is flexible and takes into account local conditions, as well as the characteristics of a particular enterprise. The GMP system includes a number of independent rules: production design rules and norms, drug registration rules, production licensing and validation rules, self-inspection rules and state production inspection rules.
Compliance with GMP rules is, first of all, a transition from quality control of finished products to quality assurance at all stages of production. This is what should be subordinated to the issues of reconstruction of industrial premises and equipment renewal. Validation is of great importance in relation not only to technological and control processes, but also to equipment, premises, systems, and production products.
According to GMP, there are such types of sterile products: drugs subject to sterilization and drugs produced under aseptic conditions. This gradation is the basis for the approach to the design of production facilities, the validation of technological processes, the selection of appropriate purity classes for various operations and process stages.
General GMP requirements for the production of sterile products provide for the presence of clean areas, personnel access and / or the receipt of materials, the equipment of which must occur through air locks. Clean zones are classified according to the required environmental characteristics. Each process operation requires a certain operating cleanliness class to minimize the risk of particle or microorganism contamination, including the risk of cross-contamination. These areas or rooms are designed in such a way as to provide a certain class of cleanliness in an equipped and functioning state. Equipped state - a condition in which the cleanroom system is fully prepared, the production equipment is fully installed and ready for operation, but the technological process and personnel are absent. Functioning state (in the new GMP requirements - operated) - a condition under which the premises and equipment operate in the established mode with a certain number of working personnel.
For the production of sterile drugs, the following purity classes are distinguished, for each of which there is a maximum allowable number of particles in the air:
class A: local high-risk operation area for product quality (packing, sealing, preparation and mixing of components under aseptic conditions) with laminar (unidirectional) flow, the air speed of which is 0.45 m/s ± 20%;
class B: environment for zone class A in case of preparation and filling under aseptic conditions;
Classes C and D: Designed for less critical steps in the production of sterile products.
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Russian manufacturer of operating tables and other medical equipment Startechmed.ru. We produce under the STARTECH brand: operating tables, gynecological chairs, functional beds, electrocoagulators, anesthesia and respiratory equipment, patient monitors About company ⋅ Contacts ⋅ Send message ⋅ Files ⋅ Market ⋅ Articles ⋅ Announcements ⋅ Video ⋅ Photo
Sale and service of medical equipment. CJSC "DIAMED" is the exclusive distributor of Fazzini (Italy), Emed (Poland) products and the official distributor of Schmitz (Germany), Melag (Germany), Newtech Inc. (USA) products in Russia. Priority areas are: Aria dental units (Slovakia), Fazzini surgical aspirators, Melag sterilization equipment, Schmitz gynecological chairs and operating tables, Newtech multi-parameter patient monitors, equipment for operating rooms. About company ⋅ Contacts ⋅ Send message ⋅ Files ⋅ Market ⋅ Articles ⋅ Announcements ⋅ Video ⋅ Photo
Supplier of medical equipment since 1993. Freezers and refrigerators are medical. Air and water disinfection equipment. UV lamps. Fetal monitors, colposcopes. Electrocardiographs and other medical products. About company ⋅ Contacts ⋅ Send message ⋅ Files ⋅ Market ⋅ Articles ⋅ Announcements ⋅ Video ⋅ Photo
LLC "Medical Company "MARIYA" began its work in June 2009.
Every year the list of the company's products is expanding more and more and currently covers such sections as:
Medical equipment,
- medical instruments,
- medical consumables,
- dentistry,
- medical furniture
We sell medical products from leading Russian and foreign manufacturers.
Some of our largest suppliers are:
OJSC "MIZ-Vorsma" - medical instruments (Russia)
JSC "MIZ im. Gorky" - medical instruments (Russia)
OJSC "Mozhaisky MIZ" - medical instruments (Russia)
SAMMAR Ltd - medical instruments (Pakistan)
Doschatinsky plant of medical equipment - medical instruments and furniture (DZMO) (Russia)
Kazan Medical Instrument Plant (KMIZ) - medical instruments (Russia)
LLC "PP Oka-Medic" (Navashino) - medical furniture and sterilization boxes (Russia)
LLC NPF "Medicon" - stainless steel trays, cups (Russia)
Elatomsky instrument plant - medical equipment (Russia)
CJSC "Kront-Med" - medical equipment (Russia)
You can purchase medical products from our company from any geographic location. We will ship your order by any transport company: "Business Lines", "Autotrading", "Attenta", "ZhelDorEkspetsiya", "DPD" (Bizpak). About company ⋅ Contacts ⋅ Send message ⋅ Files ⋅ Market ⋅ Articles ⋅ Announcements ⋅ Video ⋅ Photo
Firm "DAR"-Official dealer (partner) SANYO-AWT (JP), IP Medidustriya Servis-MEDIN (BY), CJSC "Trans-Signal" НН (RUS), PARI (DE), Hospitex (IT), Proteus (AUS) ).
The DAR company is a supplier of laboratory medical equipment, medical equipment, HONDA-SONOSITE-GE*LOGIQ*VIVID-MEDISON-FUKUDA-ALOKA-HITACHI-SIUI ultrasound scanners, NEOSOFT-PHILIPS-HITACHI-GE-TOSHIBA tomographs, imported medical-pharmaceutical refrigerators and domestic production, tools, consumables, technological equipment for the pharmaceutical industry (bottling and capping lines for pharmaceutical solutions), water treatment equipment for pharmaceutical production, we assist in the design and complex equipment of medical and sanatorium-resort institutions in Russia and the CIS .
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Supplier of medical equipment in Russia. Customers are hospitals and polyclinics, departments of a narrow focus of medical institutions and perinatal centers. We work on the terms of comprehensive support.
We cooperate with German manufacturers:
Dr. Mac GmbH. Creates lighting devices for medical institutions.
- Compart Umwelttechnik. Produces oxygen concentrators.
- Modul Technik GmbH. It manufactures medical consoles and gas supply systems.
- Bitmos GmbH. Manufactures portable and portable oxygen concentrators. About company ⋅ Contacts ⋅ Send message ⋅ Files ⋅ Market ⋅ Articles ⋅ Announcements ⋅ Video ⋅ Photo
Manufacture and sale of a unique multifunctional barotherapy device MKV-01 "IVAVITA" for use in urology, gynecology, sanatorium and medical institutions and physiotherapy. About company ⋅ Contacts ⋅ Send message ⋅ Files ⋅ Market ⋅ Articles ⋅ Announcements ⋅ Video ⋅ Photo
Alfa-Medtechnika Medical Company offers a wide range of laboratory equipment:
Biochemical and ELISA analyzers manufactured by AWARENESS TECHNOLOGY (Stat Fax) (USA), HTI (USA), HOSPITEX DIAGNOSTICS (Italy), HUMAN (Germany), Roshe (Switzerland)
Hematological analyzers ABACUS by DIATRON (Austria), ABX by HORIBA ABX Diagnostics (France), ERMA (Japan), Blood gas and electrolyte analyzers by Medica (USA), Opti Medical (USA), Urine analyzers by BAYER Diagnostics (USA), HTI (USA), Coagulometers from Behnk, Elektronic (Germany), HTI (USA), Microscopes from Micros (Austria), Olympus (Germany) and Unica (USA)
Products of Biohit and Thermo Fisher Scientific (Lenpipet) (Mechanical and electronic pipettes).
Sets of biochemical reagents DiaSys Diagnostic Systems GmbH (DiaSys) Germany and DIACON-DiaSys (DDS) Russia. Diagnostic equipment from Schiller AG (Switzerland). Endoscopic equipment from Olympus and Pentax (Japan)
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The main activities of the enterprise are the development, industrial production of medical equipment for laboratories (State License 99-03-002003 dated May 18, 2010 issued by the Federal Service for Supervision of Health and Social Development of the Russian Federation).
