Import of medical devices to Russia

• Medical Devices Market in Russia
• Export of medical devices from Russia
• Export of medical devices from Moscow

2024: US allows exports of medical equipment to Russia

At the end of April 2024, the US authorities eased sanctions against Russia, allowing operations with some types of medical equipment.

The MED licensing exception allows the export, re-export or transfer (within the country) of medical devices designated as EAR99 to Russia, Belarus, the US Federal Register website says (quoted by Vedomosti).

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It follows from the document that the permit also applies to hematological analyzers, pacemakers, dental instruments and implants, blood transfusion equipment, hearing aids and ECG devices, heart valves, monitors for hospitals, ultrasound and IVL devices, parts for CT and MRI scanners.

The US authorities emphasize that the exceptions will not apply to parts and components that can be used in the industrial sector or military-industrial complex.

Prior to that, the US Treasury Department issued a general license that allows transactions with Russia related to food, fertilizers, seed, medicines and medical equipment. Nikolai Bespalov, Development Director of the analytical company RNC Pharma, in a conversation with RIA Novosti, expressed confidence that the United States is unlikely to introduce new restrictions on the supply of goods and medical products to Russia.

The probability that these restrictions will be introduced in the future is relatively low. I don't think that any of the Russian manufacturers built their development strategy only on the likelihood of such restrictions, the expert believes.

According to him, changes in the Russian economy and partly in the policy of individual foreign companies "for domestic companies provide a wide range of opportunities for the development and displacement of competitors from the market."^[1]

2023

Reduced imports of minimally invasive surgery and diagnostic equipment to $119 million for the second consecutive year

In 2021-2023, imports of equipment for minimally invasive surgery and diagnostics to Russia decreased by 45% - from $215 million to $119 million. Relevant data are provided in the BusinesStat study, the results of which were published on June 26, 2024.

The review takes into account purchases of such products as arthroscopes, laparoscopes and thoracoscopes, endoscopic devices for the gastrointestinal organs, otorhinolaryngology and pulmonology, urological endoscopic devices, etc. In addition, certain gynecological devices are considered, such as colposcopes and hysteroscopes, as well as endoscopes used in neurosurgery. The study includes only entire types of equipment for minimally invasive surgery and diagnostics, some parts of the devices were not included in the review. Among the significant players in the industry are called Medplant"," "Endo Stars," "," "WestMedGroup NPF," "Eleps Endomedium +," etc.

According to estimates, in 2019 the volume of imports of these devices to Russia amounted to $112.5 million. In 2020 and 2021, an increase of 21.7% and 57% was recorded, respectively, to $137 million and 215 million. Thus, in two years, the volume of imports has doubled. However, in 2022, purchases of imported equipment by Russian customers decreased on an annualized basis by 27.5% - to $155.9 million. In 2023, there was a decrease of 23.8% with a final result of $118.8 million.

The study says that in 2022, the decline was caused by the stabilization of the situation with the COVID-19 pandemic. In conditions of uncertainty with the supply of medical institutions, the purchase of endoscopes continued, but compared with the high base of 2021, imports decreased. The main purchases of equipment for minimally invasive surgery and diagnostics were made precisely in 2021 - against the background of pent-up demand for medical care after quarantine restrictions.^[2]

Imports of medical products to Russia for the year decreased by 4.5%

According to the results of 2023, imports of medical devices to Russia decreased by 4.5 percentage points, Deputy Prime Minister Tatyana Golikova said at a strategic session on the national project "New Health Saving Technologies" in early June 2024.

According to Golikova, the decline in imports is associated both with the development of Russian production of more affordable and competitive products, and with a decrease in actual demand after the rush demand of 2022.

The Deputy Prime Minister noted that as a result, the average annual volume of industrial production of medicines and medical devices "exceeds other sectors of the economy and comes in third place among other industries."

According to the data, in Rosstat 2023 Russia , medical equipment was produced by 50.3 billion. rubles Over the past five years, this figure has almost tripled - from 18.5 billion rubles in 2018.

The Ministry of Industry and Trade of the Russian Federation reports that the share of domestic medical equipment in 2023 reached 29%, showing growth in the last few years.

According to the Vademecum analytical center, the share of imported diagnostic equipment in state medical institutions in need of service reaches 80-100%. At the same time, the percentage of worn out equipment is 10-20%.

In December 2023, the Government of the Russian Federation banned the purchase of a number of types of foreign ventilators by state institutions, analogues of which are in Russia. This decision was made in order to support domestic manufacturers of IVL systems and more actively introduce Russian equipment into specialized institutions.

Golikova also added that almost 118 million people receive medical care in Russia annually, which is 81% of the country's population.^[3]

2022: Year-over-year increase in intravenous catheter imports soars 172.4% to 36.5 million

In 2022, about 36.5 million intravenous catheters were delivered from abroad in Russia, which is 172.4% more than a year earlier. Such data are given in a study published in early September 2023 by the analytical agency BusinesStat.

According to experts, the 2.7-fold increase in the import of catheters in the Russian Federation is due to the fact that under the conditions of sanctions pressure on the country, domestic companies sought to create stocks of the most necessary medical instruments and consumables. For the effective functioning of the health care system in the new economic and political conditions, the Government of the Russian Federation took measures to simplify the purchase of medical products. Since the Russian market for venous catheters is formed exclusively by imported products, medical institutions were interested in providing themselves with these products for future use, so that the availability of medical care in the country does not decrease, the report says.

In addition, in 2022, the consumption of intravenous catheters increased in Russia due to an increase in the number of patients requiring infusion therapy and frequent blood sampling. In the process of infusion therapy, catheters are used in cases where the patient needs to administer intravenous drugs, blood components, infusion solutions or parenteral nutrition for a long time or repeatedly. The consumption of venous catheters has significantly increased due to the treatment of victims in the zone of the special military operation of the Russian Federation in Ukraine.

In 2022, intravenous catheters to Russia were supplied mainly by partners from India - imports from this country increased 24 times. In the context of increasing purchases of medical consumables, clinics chose inexpensive options for medical devices. In the global vascular catheter market, Indian products are offered at relatively cheap prices, analysts say.^[4]

2021: Mishustin simplified the import of medical devices for seriously ill patients from abroad

In September 2021, the Government of the Russian Federation approved new rules for issuing permits for the import of medical devices for patients with serious diseases. Starting March 1, 2022, charitable foundations and medical organizations will be able to apply for such permits through public services.

As reported in the document signed by Prime Minister Mikhail Mishustin, the decision concerns the import of medical devices unregistered in Russia and not having domestic analogues, which are necessary for specific patients for vital reasons.

Now through public services. Mishustin simplified the import of medical devices for seriously ill patients from abroad

Previously, such products were imported on an individual basis in agreement with Roszdravnadzor, but there was no clear regulation, the press service of the Cabinet said.

From March 1, 2021, Roszdravnadzor will issue a special permit for the import of such products. Funds and clinics will be able to send an application for its receipt and the necessary documents in electronic form through the portal of public services. The permission of Roszdravnadzor will be placed in the applicant's personal account for five days. It is assumed that this format will simplify and speed up the process of importing medical devices for patients with serious diseases.

Earlier, the government approved the rules for the import and issuance of drugs not registered in Russia, which were supposed to help doctors quickly fill out applications for them. Thus, the opportunity to get the drug appeared, but only on an individual basis.

Earlier it was reported that the parents of children with epilepsy asked the Ministry of  Health to resume deliveries to Russia of the vital drug Suksilep. As the initiator of the appeal, the mother of a seven-year-old girl with epilepsy, explained, the medicine was not registered in Russia, so it was possible to get it only after the decision of the medical commission.^[5]

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