Medical factories and manufacturers of medical equipment. Medical products: list

The assortment of pharmacies must necessarily include goods for sanitary and hygienic purposes and patient care items, since in case of serious illnesses, after surgical interventions, for non-ambulatory patients and in other cases, they are necessary to ensure human life. They belong to medical products, the range of which includes hygiene and dressing products, medical clothing, etc.

Medical products (IMD) are medical products made of glass, polymer, rubber, textile and other materials, sets of reagents and control materials for them, other consumables and products, mostly single-use, that do not require maintenance during use (order of the Ministry of Health RF No. 444 dated December 13, 2001 “On the validity period of registration certificates for medical products and medical equipment”).

This group of products accounts for about 20% of the total medical device market, which emphasizes its importance for the medical industry. Currently, only a fifth (20%) of products in this area are domestic.

Order of the Ministry of Health and Medical Industry No. 161 dated June 9, 1995 regulates the assortment list of medical products, patient care, prevention, sanitation and hygiene items that should be in pharmacies.

Assortment list of medical products, patient care items, prevention, sanitation and hygiene for pharmacies (Order No. 161 of the Ministry of Health and Medical Industry of the Russian Federation dated June 9, 1995)

First aid kits (sets) individual, first aid, universal, mother and child

Bandages

Blood suction cups

Compress paper

Eye baths

Ankles

Hemostatic tourniquets

Injection needles

Colostomy bags and collection bags

Catheters

Oilcloth lining, compress, polyvinyl chloride, medical

Children's dental rings

Uterine rings

Crutches for adults, children, teenagers and tips for them

Backing circles

Esmarch mugs (irrigator)

Ophthalmic scapulas

Breast pumps

Urinals

Knee pads

Fingertips

Medical scissors

Disposable diapers

Women's hygiene bags (pads), tampons

Medical gloves

Eye pipettes

Spittoons

Sippy cups

Oxygen pillows

Hygienic rubber belts

Ice bubbles

Respirators, medical masks

Baby pacifiers

Syringes

Means of contraception (caps, condoms, intrauterine devices)

Cups for taking medicines

Bedpans

Suspensions - Medical thermometers

Medical tubes

Stockings, half-stockings (knee socks) medical

Medical syringes

Certain products (catheters, scissors, thermometers, syringes, etc.) are discussed in other topics. This topic discusses groups of other products.

According to their functional purpose, sanitation, hygiene and patient care products can be systematized into groups presented on

Classification of sanitary and hygiene products, patient care items by functional purpose

Patient care items for taking medications, mainly liquids and water, include cups, sippy cups, eye pipettes, etc.

To perform some medical procedures, blood suction cups, Esmarch cups, hemostatic tourniquets, gloves, syringes, thermometers, etc. are used.

If the patient is in bed rest, sanitation and hygiene products for the toilet are needed: bedpans, urinals, colostomy bags, oilcloth.

Certain products are intended for the personal hygiene of patients, in particular, bandages, catheters, uterine rings, spittoons, jockstraps, etc.

At the same time, the assortment also includes sanitary and hygiene products that are needed by healthy people, children, women, including pregnant women, for example, first aid kits, children’s dental rings, breast pumps, finger pads, pacifiers, feminine bags, masks, medical respirators etc.

In recent years, groups or series of products designed to solve certain problems of healthy or sick people have appeared on the Russian pharmaceutical market. For example, the company Artsana (Italy) offers a group of products - care products

for newborns and young children, as well as accessories for nursing women, including:

Physiological project KiKKO:

Physiological nipples have original design features, namely: an anti-hiccup valve in combination with unloading channels-grooves that regulate the flow of air into the bottle;

Physiological “drop” pacifiers have a teardrop shape;

Physiological bottles consist of a cup cap, a physiological nipple, a hygienic plug, a bottle, a valve that prevents colic in children, and a removable bottom;

The adjustable breast pump is designed for expressing breast milk in nursing women.

The Tena series of products - for the care of patients with urinary incontinence, includes adult diapers and absorbent sheets. The use of these products simplifies patient care and provides the patient with a feeling of comfort.

Types of goods:

“Lady” diaper pads for women have an anatomical shape, are suitable for use both night and day, invisible under clothing; Normal, extra, super types are available, in packages of 7-12 pcs.;

“Slip” pads are available in two sizes: M - medium, L - large, 10 pcs. in packaging;

“Comfort” pads are supplied complete with fixing panties;

“Bed” sheet pads, size 60x60 or 60x90, 20-30 pcs. in packaging.

These goods are of domestic production: the company "SCA Hygiene Products" (Russia).

A certain group of products consists of personal hygiene products for women during the menstrual cycle and for every day. These include pads, tampons, bags that perform one function - absorption (absorption) of body secretions and ensuring women's comfort.

Hygienic intravaginal products for use on “critical” days - Tampax tampons are made from specially bleached cotton fiber, viscose or a mixture thereof, and have a return cord. Available in three types: mini, normal and super-super plus; 8 pcs per pack

They are compact and allow a woman to lead an active lifestyle. Researchers from the Russian Association of Obstetricians and Gynecologists have proven that they do not cause changes in the vaginal microflora and are safe for women’s health. Tampons should be changed every 4-8 hours. At the same time, you need to know the precautions, because if an unexpected deterioration in your health occurs when using tampons (fever, vomiting, diarrhea, muscle pain, dizziness, etc.), you should immediately consult a doctor. The cause may be toxins produced by staphylococcus. These health changes are called toxic shock syndrome. There are no reported cases of TSS in Russia yet. The use of tampons during the postpartum period, especially during surgical interventions, is undesirable and is possible only after consultation with a doctor. Issued by branches of Procter and Gamble (USA).

Procter and Gamble (USA) also produces a series of hygiene products for women, in particular:

“Olways Ultra” - hygiene products for use on “critical” days, and are available in four types depending on the characteristics of these days for women: 1) light - pad length 240 mm; 2) normal - 284 mm; 3) super - 284 mm; 4) night - 302 mm.

These pads absorb moisture well, as they have a unique “Driven” top layer, consisting of extremely fine three-dimensional funnel-shaped pores. It allows moisture to enter the gasket and prevents it from coming to the surface under pressure. The pads have elongated elastic “wings” for reliable fixation to the laundry. The materials from which the pads are made do not support the growth and reproduction of bacteria, do not irritate the skin and do not cause allergies. Pads are changed 4-6 times a day. Shelf life: 2 years. Produced by company branches in Germany, Hungary, and Turkey.

A series of "Oldaze" pads is available for daily use. They have a softer surface, control the appearance of unpleasant odors, create comfortable conditions for the female body, and prevent skin irritation and the feeling of diaper rash.

The pads available are "Oldaze Black" in black, "Oldaze Black Tanga" - black, "Oldaze Tanga" - regular color, with a shape modified for underwear, "Oldaze Ladge" - large, normal - medium, resin - small, in packs of 16-22 pieces, shelf life 2 years. Made in Germany.

Series O.BI. (o.b.) - tampons are made of viscose, cotton, have a non-woven surface and a return cord. Available in different sizes to suit different discharge volumes. Requires changes every 3-6 hours. Tampons O.BI. Comfort have a special silky surface. In packs of 8 and 16 pcs. Produced by Johnson & Johnson (Austria).

A series of sanitary napkins (pads) for daily use “Care Free” are made of cotton, the surface is soft, impregnated with a special solution containing various substances that maintain the natural acid-base balance of the intimate area, chamomile extract prevents the possibility of inflammation and irritation. Thin, flexible, shape follows the lines of the body, securely fixed on underwear. In packages from 16 to 30 pcs., may be black,

Various types are available: “Care Free”, “Care Free Black”, “Care Free Flexiform” (breathable), “Care Free Fresh” (with the aroma of freshness), “Care Free Ultra” (for use on menstrual periods), etc. Produced by Johnson & Johnson (Italy).

The first GMP rules were adopted in 1963 in the USA, then in Canada, Italy, England and 40 other countries. GMP rules are general guidelines establishing the procedure for organizing the production process and carrying out controls, and also containing minimum practical instructions for the modern correct conduct of production. Based on GMP rules, standards and documents are created in each country that regulate the production of certain types of pharmaceutical products.

In Russia, GMP rules (“Rules for the organization of production and quality control of medicinal products” - RD 64-125-91) were first developed in 1991. In subsequent years, new GMP rules and international standards appeared. They included for the first time or developed new provisions, such as quality management and 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 on July 1, 2000, and is mandatory for all organizations producing drugs and drugs ( substances). The phased implementation of OST 42-510-98 will be carried out in full until March 31, 2005, and for enterprises producing substances - until December 31, 2008.

The GMP concept is based on the understanding of the limited capabilities of drug quality control after its receipt under laboratory testing conditions. A significant drawback of assessing the quality of the final product is the conditionality of transferring the assessment of test samples to the entire controlled series.

GMP rules are systematic and preventive in nature. 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 to the end of the production cycle. The implementation of these rules is impossible without due attention to sanitation and personal hygiene in production, to technological and control documentation, and without modern equipment.

In accordance with the GMP system, the entire production process must be checked, “validated”, equipment “qualified”, control equipment “calibrated”. Moreover, all these operations must be “documented”. GMP rules, promoting 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 enterprise - output, and consumer - state.

Thus, GMP regulations aim to reduce the risk inherent in pharmaceutical production, which cannot be eliminated by controlling the quality of the final product alone.

The GMP standard (“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 of examining samples of such products, which ensures the suitability of only the samples themselves (and possibly the batches manufactured closest to the given batch), the GMP standard takes a holistic approach and regulates and evaluates the production parameters themselves. and laboratory testing.

"Good Manufacturing Practices (GMP)"

This standard is 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. The rules help minimize the risk of manufacturing errors that cannot be eliminated or prevented by quality control of the finished product alone. The most common types of errors occur:

Cross contamination;

Mixing and/or mixing up 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;

Conducting validation of all stages of production that may affect the quality of products and all significant changes in it;

Providing production with properly trained and qualified personnel, the necessary premises, appropriate equipment and services, raw materials, auxiliary, packaging and labeling materials of the required quality, as well as storage of raw materials and materials in appropriate conditions and proper transportation;

Availability of clearly and unambiguously written 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 operations required by regulations have been completed, and the resulting products meet the established requirements in terms of quantity and quality. All deviations must be carefully recorded and investigated;

Storage of current production documentation (batch reports, route maps, etc.), including documentation on the sale of the finished product, which makes it possible to track the progress of each batch of products over a certain period of time, in an accessible form in a certain place;

Storing and selling the finished product in such a way as to minimize the risk of quality degradation;

The procedure for returning, if necessary, any batch of a 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, including sampling, testing and issuing relevant documents to ensure that all necessary tests have 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. The structure of each pharmaceutical enterprise must have a quality control department (QCD).

Production process

The main purpose of pharmaceutical production is the production of drugs and drugs. In this case, raw materials, auxiliary, packaging and labeling materials are used. The most important part of the quality assurance system for finished products is properly compiled documentation. It must be related to all sections of the GMP rules and reflect their basic requirements. The production process must be carried out in strict accordance with technological regulations, which reflect the requirements of GMP rules, which ensures the proper quality of the finished product.

Great 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, link to RD, indication of possible suppliers, volumes and delivery times, instructions for sampling and incoming control, quality requirements, proper storage conditions and precautions, expiration date or date of additional quality control. All specified requirements are strictly observed and controlled.

The resulting raw materials are subjected to incoming control according to ND, for which average samples are taken from each batch. Only raw materials that comply with RD are released into production with permission from the Quality Control Committee. Samples are left from each batch of raw materials in case of repeated analytical tests. 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, and, if necessary, for pyrogenicity and the absence of mechanical inclusions.

The production process must strictly comply with technological regulations and guarantee the release of drugs or pharmaceutical drugs, the quality of which meets the requirements of the RD. The conditions for carrying out the technological process must ensure its flow, consistency, safety and trouble-free operation of technological equipment, and optimal loading. It is necessary to exclude or minimize contact of personnel with raw materials, packaging material, and finished product during its receipt. Strict documentation of all stages of the technological process is ensured, and generated 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 process of production of sterile drugs, which requires a special set of measures.

During the production process, stage-by-stage control is carried out. Is it carried out by employees of the workshop laboratory? regularly) and OKC (periodically). The purpose of stage-by-stage control is to prevent the release of a finished product that does not meet the requirements of the RD. Control is carried out with periodic checks in relation to a given product and production conditions in strict accordance with current industry documents, technological regulations and written instructions.

During stage-by-stage control, the following is checked: compliance with the requirements of the RD of the raw materials, semi-finished products, packaging and other materials used; sanitary condition of workshops, workplaces and equipment; performing technological operations and observing technological operating conditions. The results of stage-by-stage control are reflected in the corresponding journals. If deviations from the modes and norms of the technological process are detected, 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 maintaining documentation during 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 registration 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 and dosage of the drug; the authenticity, quantity and quality of each type of raw material for all stages of production; description of operations for the production and storage of intermediate products and pharmaceutical drugs; theoretical yield and acceptable limits of actual yield of the finished product at different stages; description of methods of packaging and labeling of drugs; description of the necessary control analyzes at each stage of production and the name of the departments performing control.

Thus, the drug production process at each stage is accompanied by quality control of raw materials, packaging, auxiliary and other materials, intermediates 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 technological equipment (including computer systems); assessment of the conditions and parameters of the technological process and the permissible limit of possible deviation in its implementation; assessment of analysis methods, preparation of protocols and reports certifying the technological process.

Validation must 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).

Repeated validation (revalidation) is carried out in the following cases: changes in RD for pharmaceutical products, raw materials, auxiliary, packaging and other materials; changes in technological documentation; replacement or repair of equipment; re-equipment of production premises, heating, ventilation and other auxiliary systems; identifying unregulated deviations in the technological process; planned validation in accordance with approved schedules.

The implementation of GMP rules is a means of achieving sustainable high quality products, 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: rules and regulations for production design, rules for drug registration, rules for licensing and validation of production, rules for self-inspection and state inspection of production.

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 precisely what the issues of reconstruction of production premises and equipment renewal should be subordinated to. 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 the following 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, and the selection of appropriate cleanliness classes for various operations and process stages.

General GMP requirements for the production of sterile products require clean areas, personnel access and/or the flow of materials that must be equipped through airlocks. Clean areas are classified according to the required environmental characteristics. Each process operation requires a certain class of operational cleanliness to minimize the risk of contamination by particles or microorganisms, including the risk of cross-contamination. These areas or premises are designed in such a way as to ensure a certain class of cleanliness when equipped and functioning. Equipped state - a condition in which the cleanroom system is fully prepared, the production equipment is fully installed and ready to operate, but the process and personnel are absent. Operating state (in the new GMP requirements - operated) is 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 permissible number of particles in the air:

class A: local area of high-risk operations for product quality (packing, capping, 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: Class A environment when prepared and filled under aseptic conditions;

Classes C and D: are intended for less critical stages of sterile production.

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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 the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Sales and service of medical equipment. JSC "DIAMED" is the exclusive distributor of products from Fazzini (Italy), Emed (Poland) and the official distributor of products from Schmitz (Germany), Melag (Germany), Newtech Inc. (USA) in Russia. The priority areas are: Aria dental units (Slovakia), Fazzini surgical suction units, Melag sterilization equipment, Schmitz gynecological chairs and operating tables, Newtech multi-parameter patient monitors, equipment for equipping operating rooms. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Medical equipment supplier since 1993. Medical freezers and refrigerators. Equipment for air and water disinfection. Ultraviolet lamps. Fetal monitors, colposcopes. Electrocardiographs and other medical products. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

LLC Medical Company MARIA began its work in June 2009.
Every year the company’s product list 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:

JSC "MIZ-Vorsma" - medical instruments (Russia)
JSC "MIZ im. Gorky" - medical instruments (Russia)
JSC "Mozhaisk MIZ" - medical instruments (Russia)
SAMMAR Ltd - medical instruments (Pakistan)
Doschatinsky medical equipment plant - 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" - trays, stainless steel glasses (Russia)
Elatomsky Instrument Plant - medical equipment (Russia)
CJSC "Kront-Med" - medical equipment (Russia)

You can purchase medical products from our company from any geographical location. We will ship your order by any transport company: “Business Lines”, “Autotrading”, “Attenta”, “ZhelDorExpetition”, “DPD” (Bizpak). About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Company "DAR" - Official dealer (partner) SANYO-AWT (JP), Individual Entrepreneur Medindustriya Service-MEDIN (BY), CJSC "Trans-Signal" NN (RUS), PARI (DE), Hospitex (IT), Proteus (AUS) ).
The DAR company is a supplier of laboratory medical equipment, medical equipment, ultrasound scanners HONDA-SONOSITE-GE*LOGIQ*VIVID-MEDISON-FUKUDA-ALOKA-HITACHI-SIUI, tomographs NEOSOFT-PHILIPS-HITACHI-GE-TOSHIBA, imported medical and pharmaceutical refrigerators and domestic production, tools, consumables, technological equipment for the pharmaceutical industry (filling and capping lines for medicinal preparations and solutions), water purification equipment for pharmaceutical production, we provide assistance in the design and comprehensive equipment of medical and sanatorium-resort institutions in Russia and the CIS . About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Supplier of medical equipment in Russia. Customers include hospitals and clinics, specialized departments of medical institutions and perinatal centers. We work on the terms of comprehensive support.

We cooperate with German manufacturers:

Dr. Mach GmbH. Creates lighting devices for medical institutions.
- Compart Umwelttechnik. Produces oxygen concentrators.
- Modul Technik GmbH. Manufactures medical consoles and gas supply systems.
- Bitmos GmbH. Manufactures portable and portable oxygen concentrators. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Production and sale of a unique multifunctional barotherapeutic device MKV-01 "IVAVITA" for use in urology, gynecology, sanatorium-resort and medical-prophylactic institutions and physiotherapy. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

The medical company "Alfa-Medtechnika" offers a wide range of laboratory equipment:
Biochemical and immunoenzyme analyzers from AWARENESS TECHNOLOGY (Stat Fax) (USA), HTI (USA), HOSPITEX DIAGNOSTICS (Italy), HUMAN (Germany), Roshe (Switzerland)
Hematological analyzers ABACUS from DIATRON (Austria), ABX from HORIBA ABX Diagnostics (France), ERMA (Japan), Blood gas and electrolyte analyzers from Medica (USA), Opti Medical (USA), Urine analyzers from 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 dispensers).
Sets of biochemical reagents DiaSys Diagnostic Systems GmbH (DiaSys) Germany and DIAKON-DiaSys (DDS) Russia. Diagnostic equipment from Schiller AG (Switzerland). Endoscopic equipment from Olympus and Pentax (Japan) About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

The main activities of the enterprise are the development and industrial production of medical equipment for laboratories (State license 99-03-002003 dated May 18, 2010, issued by the Federal Service for Surveillance in Healthcare and Social Development of the Russian Federation).

Article 66. Types of pharmaceutical activities

Article 65. System of circulation of medicines, medical devices and medical equipment

Article 64. Scientific and medical examination

1. The objects of scientific and medical examination are:
1) draft programs of fundamental and applied scientific research;
2) republican targeted scientific and medical programs;
3) results of completed scientific and medical programs;
4) scientific works nominated for state awards of the Republic of Kazakhstan;
5) scientific and medical developments planned for implementation in healthcare practice.
2. The procedure for conducting scientific and medical examination is determined by the authorized body.

SECTION 4. PHARMACEUTICAL ACTIVITIES AND HANDLING
MEDICINES, MEDICAL PRODUCTS AND
MEDICAL EQUIPMENT

Chapter 13. PHARMACEUTICAL ACTIVITIES

The unified system for the circulation of medicines, medical products and medical equipment includes:
1) state body in the field of circulation of medicines, medical products and medical equipment;
2) state expert organization in the field of circulation of medicines, medical products and medical equipment and its territorial divisions.

1. Pharmaceutical activities include the professional activities of individuals who have received higher or secondary vocational pharmaceutical education, as well as legal entities operating in the field of healthcare.
2. Pharmaceutical activities include the following types:
1) production of medicines;
2) production of medical products;
3) production of medical equipment;
4) production of medicines;
5) manufacturing of medical products;
6) wholesale sales of medicines;
7) wholesale sales of medical products;
8) wholesale sales of medical equipment;
9) retail sale of medicines;
10) retail sales of medical products;
11) retail sale of medical equipment.

1. Production of medicines, medical devices and medical equipment - pharmaceutical activity, including the totality of all work necessary for the serial production of medicines, medical devices and medical equipment associated with the acquisition of raw materials, supplies and semi-finished products, the technological process, including with the implementation of one of its stages, storage, sale of manufactured products, as well as all types of accompanying control.
2. The production of medicines, medical products and medical equipment is carried out in accordance with the production rules and regulatory documents on standardization by entities in the field of circulation of medicines, medical products and medical equipment that have received a license for the right to produce medicines, medical products and medical equipment. technology.
3. Rules for production and quality control, as well as for conducting stability tests and establishing shelf life and re-control of medicines, medical devices and medical equipment are approved by the Government of the Republic of Kazakhstan.
4. The production of medicines, medical products and medical equipment is prohibited:
1) those that have not passed state registration in the Republic of Kazakhstan, with the exception of medicines, medical products and medical equipment intended for examination during their state registration, during debugging and launch of equipment and technological processes, as well as medicinal substances produced under Good Manufacturing Practice conditions practices;
2) without a license for the right to produce medicines, medical products and medical equipment;
3) in violation of the Rules for the production and quality control of medicines, medical products and medical equipment.
5. Produced and imported medicines:
1) must not contain dyes and auxiliary substances, the list of which is prohibited for use in the Republic of Kazakhstan by the authorized body;
2) must be subject to control in accordance with the regulatory and technical document on monitoring the quality and safety of medicinal products, developed in accordance with the Rules for the preparation, approval and examination of the regulatory and technical document on monitoring the quality and safety of medicinal products, approved by the authorized body.
6. The production and sale of patented medicines, medical products and medical equipment are carried out in accordance with the legislation of the Republic of Kazakhstan in the field of intellectual property.
7. The production of medical devices and medical equipment intended for diagnosis or treatment must ensure their safety, provide for their use in accordance with their functional purpose and eliminate the risk of user errors when interpreting the results of diagnosis or treatment.
Footnote. Article 67 as amended by the Law of the Republic of Kazakhstan dated 07/05/2011 No. 452-IV (shall be enforced from 10/13/2011).

Medical factories are a large group of enterprises that produce medical equipment and medical products. The medical industry is called upon 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 that produce products for medical needs 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 medical-biological drugs and substances:

medical preparation 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 military use, as a result of conversion, become available for civilian use and are implemented in the creation of modern medical equipment.

The most popular 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, ultrasound diagnostic devices);
equipment and products for cardiovascular surgery;
equipment and products for urology and nephrology.

52% of all medical products produced in the country are produced 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 market for medical products. However, export volumes of medical products and equipment produced by Russian enterprises are steadily increasing. The products of Russian medical factories are supplied not only to its closest neighbors - Kazakhstan, Ukraine, Uzbekistan, but also to foreign countries - Germany and the USA.

On 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 drugs 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, due to which the competitiveness of Russian pharmaceutical products in the domestic and foreign markets is gradually increasing.

One of the main trends in recent years is the opening of factories in Russia by large foreign pharmaceutical corporations. However, there has been a desire on the part of domestic manufacturers to resume production of previously produced substances, create new original high-tech substances and expand the range of drugs produced.