1. Medical products are any instruments, devices, instruments, equipment, materials and other products used in 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 prevention, diagnosis, treatment and medical rehabilitation diseases, monitoring the condition of the human body, conducting medical research, restoration, replacement, 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 products can be recognized as interchangeable if they are comparable in functionality, quality and technical specifications and can replace each other.
2. Medical products are divided into classes depending on the potential risk of their use and into types in accordance with the nomenclature classification of medical products. Nomenclature classification medical products are approved by the authorized federal body executive power.
3. The circulation of medical devices includes technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical devices, their state registration, production, manufacturing, import into the territory Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, state control, storage, transportation, sales, installation, commissioning, application, 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 production, manufacturing, 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 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 the manner established by the Government of the Russian Federation or the federal executive body authorized by it is permitted.
5. Medical products that are manufactured according to individual orders of patients who are subject to special requirements for their intended purpose. medical workers and which are intended exclusively for personal use by a specific patient, as well as medical products intended for use in the territory of an international medical cluster or in the territories of innovative scientific and technological centers, are not subject to state registration. The specified medical products 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 the previous edition)
6. The procedure for importing medical devices into the territory of the Russian Federation for the purposes 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 as part 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, effectiveness and safety of medical products, as well as testing for the purpose of approval of the type of measuring instruments (in relation to medical products related to measuring instruments in the field government regulation ensuring the uniformity of measurements, the list of which is approved by the authorized federal executive body).
9. For state registration of medical devices and 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 the previous edition)
11. The following information is entered into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices:
(see text in the previous edition)
1) name of the medical product;
2) date of state registration of the medical device and its registration number, validity period 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 the medical device or surname, first name and (if any) patronymic, place of residence individual entrepreneur- manufacturer (manufacturer) of the medical device;
(see text in the previous edition)
9) address of the place of production or manufacture of the medical device;
10) information about interchangeable medical products.
12. Falsified medical product - a medical product accompanied by false information about its characteristics and (or) manufacturer (manufacturer).
13. Poor quality medical product - a medical product that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer) or, in the absence of such documentation, the requirements of other regulatory documentation.
Article 66. Types of pharmaceutical activities
Article 65. System of the sphere of circulation medicines, products medical purposes and medical equipment
Article 64. Scientific and medical examination
1. The objects of scientific and medical examination are:
1) projects of fundamental and applied programs 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
IN unified system in the sphere of circulation of medicines, medical devices 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 professional activity individuals who have received higher or secondary professional pharmaceutical education, as well as legal entities carrying out activities 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) manufacturing 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 sales of medicines;
10) retail sales of medical products;
11) retail sale of medical equipment.
1. Production of medicines, medical products and medical equipment - pharmaceutical activities, including the totality of all work necessary for the serial production of medicines, medical devices and medical equipment related to the acquisition of raw materials, materials and semi-finished products, the technological process, including 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 devices and medical equipment is carried out in accordance with the rules of production 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.
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, when debugging and launching equipment and technological processes, as well as medicinal substances produced under the conditions of Appropriate industrial practice;
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 Excipients, 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 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. Row 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 high degree 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 share Russian market medical equipment accounted for approximately 1.13% of the global medical products market. 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 companies 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 recent years– 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.
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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. Priority directions 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 this moment 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, glasses from of stainless steel(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 are hospitals and clinics, 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. 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 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 Supervision of Healthcare and Social Development of the Russian Federation).
People have always treated medicine as something sacredly inaccessible and incomprehensible. ordinary people. Complex diagnoses, names active ingredients in medications - all this can easily confuse an ignorant person. Often in pharmacies you will also find the inscription “List of Medical Products,” the meaning of which is not always clear. So, what is included in this list and how can knowledge of it be useful to the average buyer?
What it is?
Let's start with the fact that medical products include goods 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 require special maintenance. In the medicine market, products included in the list of “Medical Products” account for 20% of total number goods. Unfortunately, only a fifth of these products are not manufactured abroad.
Reagents, test strips and other preliminary diagnostic tools
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 test not only the patient, but also medical equipment (for example, a sterilization indicator).
Typically, products from this group are not very accessible to the general population, since using them at home is very problematic. The most popular among civilians are the test strips used in glucometers. You can buy them without a prescription, however, you need to know the model of the specific glucometer.
Identification of dangerous diseases
The next large group, which contains the approved list of medical products, is sera that diagnose certain dangerous diseases. This includes medications for the detection of shigellosis and salmonellosis. There is also a set of basic antibiotics used to determine the sensitivity of microorganisms, causing disease, to certain medications. This measure can significantly reduce the likelihood of an error in prescribing the wrong medicine.
Gloves, probes and urine bags - list of consumables
Further, the list of medical products for 2016, and previous years, contains a number of items used as consumables. Here are gloves (from non-sterile ones, 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 fields of medicine).
Also included here different types ear, for feeding babies), urinals, oilcloths used for a wide variety of manipulations. It's easier to say this group products are probably one of the largest on this list.
Catheters, needles and syringes of all shapes and sizes
Next come catheters, needles and syringes - things that are very unpleasant, but still necessary. It is worth noting that the list of “Medical Products” contains several dozen types of catheters, differing not only in diameter, but also in their functions: here you can find urological, nutritional, 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 needles - the list of products here is also extensive. Syringes, like catheters, vary in their functions and sizes: from small insulin ones to special metal ones, in addition to which a whole set of different tubes is provided.
This group also includes blood transfusion systems, without which salvation would be impossible. huge amount of people.
Dressing materials, various dressings
We must not forget about various devices for dressings when answering the question of what constitutes medical products. The list includes many items, ranging from various types cotton wool and adhesive plasters to special plaster bandages, which make life much easier for traumatologists. This also includes various napkins: sterile, impregnated medicines, both anti-inflammatory and analgesics. Of course, we should not exclude bandages, which can also be included in this group. The list includes both wound-healing dressings and those that only cover wounds and burns.
For manipulations and examinations
The list of “Medical Products” would not be complete without a variety of devices that doctors use 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 under the title “Other” includes paper for taking electrocardiograms and medical mirrors, so actively used by dentists and otolaryngologists.
Even such seemingly trifles as gels for conducting ultrasound examination, are included in this group. Simply put, this includes almost all consumables and medical instruments.
Used for necessary procedures and in-depth studies
The list of vital medical products contains entire sets of tools and consumables used for certain manipulations. This may include procedures such as hemodialysis and peritoneal dialysis, studies using a gas chromatograph and fluoro-immunoanalyzer (during which the presence of drugs and narcotic substances in the patient’s body is determined). All necessary items, from needles to reagents, are located in this group of the list.
Specialized tools and consumables
Next, the list of medicines and medical products begins to be divided into specializations. Supplies are available for cardiac surgery (this includes electrodes, vascular prostheses, introducers - everything that doctors may need in emergency). Another large group is anesthesiology and resuscitation: here you can find 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 last category is also divided into several subgroups: neurosurgery, working with the brain (drainage systems, systems for fixing fractures, catheters are needed here), thoracic surgery, specializing in organs chest(dozens of types of clamps, drugs to support breathing, inhalers, oxygen pillows) and some others. Traumatologists and orthopedists may need various pins and screws, metal plates to fix damaged 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, gas outlet and for consumables. Consumables can also include flasks for reagents used in radiation therapy. This also includes films used in X-ray studies and fluorographic photographs, as well as developers and fixers that fix the image on these films.
Consumables - nondescript, but necessary
The last and most extensive group is consumables. This includes all those tools and items that are used only once, and then either destroyed or undergo the most serious processing. Such products are spittoons, flasks, test tubes, cuvettes, pipettes, graduated cylinders, laboratory glasses - without them, carrying out medical diagnostics, and treatment of patients would be impossible. These are sometimes unnoticeable, but still necessary - the last category, which includes a list of medical products and consumables.
Registration procedure
At the same time, it is not so easy for new manufacturers to become suppliers of such products as medical devices. The list and registration certificates are approved and issued by the authorized executive body. All devices, preparations and materials are required to have such certificates. All requirements for registration of new products are contained in the Law on Fundamentals of Health Protection. A drug that is being prepared for release onto the market must undergo numerous efficacy and quality tests, based on the results of which a form is filled out. a large number of documents.
That is why registration is most often entrusted to authorized enterprises that already have experience in dealing 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 all drugs must be retested every five years, which again confirms their quality and safety. So rest assured that reagents, devices, instruments and other medical products and consumables are from the list approved by the highest government agencies, are completely safe for health.
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