News Digest 24.04.2026 — 30.04.2026
Regulators
The Russian government was asked to maintain VAT exemptions for medical device manufacturers
On April 28, Muslim Muslimov, Chairman of the National Association of Healthcare Managers (NAHM), sent a letter to Prime Minister Mikhail Mishustin requesting that the special tax regime be maintained for manufacturers of innovative medical equipment and pharmaceuticals (MV has a copy of the letter).
The sharp reduction in the simplified taxation threshold from 60 million to 20 million rubles, along with the increase in the base value-added tax (VAT) rate to 22%, creates fundamentally new fiscal conditions that require adaptation by all sectors of the economy, including strategically important ones. For the medical instrumentation and pharmaceutical industries, identified as the driver of technological sovereignty, these changes pose increased systemic risks, the statement said.
The initiative was announced during a roundtable discussion entitled "Problems of the Efficiency of Technical Equipment of Medical Institutions with Medical Equipment and Its Maintenance." "Stimulating Domestic Competitive Manufacturing, Technologies, and Innovation" at the Civic Chamber of the Russian Federation on April 28.
"Many fast-growing companies developing domestic analogues of critical products will inevitably exceed the new low threshold of 20 million rubles and will be required to become VAT payers starting in 2026. This creates a significant additional administrative and financial burden during the most crucial period—the stage of scaling up production and introducing products to the market to replace imports. The prospect of further reducing this threshold to 10 million rubles in 2028 only reinforces this trend," the letter states.
In this regard, the National Association of Healthcare Professionals (NAHP) asks the Russian government to consider introducing a special tax incentive for medical manufacturers whose products are included in lists ensuring technological sovereignty. Specifically, to reinstate the VAT exemption threshold for such companies at 60 million rubles in revenue, and to maintain the application of the simplified tax system without VAT, provided this limit is met.
"This measure will be clear and targeted, supporting precisely those manufacturers addressing import substitution challenges in healthcare. Global experience shows that strategic industries related to national security and health often benefit from targeted tax incentives. Adopting a similar approach in Russia will help preserve the capitalization of growing innovative companies and channel their resources into production development, rather than covering the increased tax burden under the reform," the letter's authors believe.
International brands will retain a significant share of the high-tech medical equipment market in 2025, particularly in the imaging, endoscopy, and intensive care segments, MV reported. In 2023, the Russian Ministry of Industry and Trade estimated the share of Russian medical devices (including equipment) at approximately 25.4% of the market, and 28.5% in public procurement. Several industry surveys, based on Rosstat data and public procurement, estimate the total medical equipment market share at approximately 29%. According to the International Medical Devices Association (IMEDA), the share of imported medical equipment in some high-tech sectors can reach 80%, particularly in the CT, MRI, and specialized surgical equipment sectors.
The Russian Ministry of Labor will establish pricing procedures for the procurement of technical rehabilitation equipment
The Russian Government adopted Resolution No. 476 dated April 27, 2026, which empowers the Russian Ministry of Labor to establish procedures for calculating initial (maximum) contract prices for the procurement of technical rehabilitation equipment (TRE), including prostheses, prosthetic and orthotic devices, and orthoses.
According to the document, the rules apply to the procurement of:
- technical rehabilitation equipment and services for the disabled;
- technical rehabilitation aids that are not medical devices;
- technical rehabilitation aids that are medical devices but are manufactured to individual patient orders for personal use. They are subject to special requirements for use by healthcare professionals and are not subject to registration in the Russian Federation as medical devices.
These rules also apply to the procurement of work on the manufacture of prostheses, prosthetic and orthotic devices, and orthoses, as well as repair services for these devices, for individuals who have suffered injuries due to industrial accidents and occupational diseases.
Furthermore, amendments are being made to Russian Government Resolution No. 847 of July 2, 2019. An exception has been added to the document for custom-made medical devices that are not subject to registration. This allows for a special pricing procedure to be applied to such purchases.
Market news
The Deputy Minister of Industry and Trade of the Russian Federation visited Russia's first plant producing medical devices for dialysis
Deputy Minister of Industry and Trade Ekaterina Priezzheva and Deputy Governor of the Kaluga Region Vladimir Potemkin visited the Pharmasyntez-Medtech production site in the Rosva Industrial Park in Kaluga. The delegation was shown the plant's readiness for operation.
The plant was created to produce equipment and consumables for hemodialysis and peritoneal dialysis, including domestically produced dialyzers for the treatment of chronic renal failure. Currently, more than 59,000 Russian citizens require regular dialysis therapy—a need almost entirely met by imports.
The first production line for peritoneal dialysis bags has already been launched. Production lines for dialyzers and lines for peritoneal dialysis and hemodialysis will be operational by the fall.
The project plays a significant role in strengthening the country's pharmaceutical sovereignty and providing patients with modern domestic equipment.
The first phase of the project marks the beginning of a large-scale import substitution program for medical equipment and products for the treatment of renal failure.
The company is certified according to GOST ISO 13485, which confirms the compliance of the quality management system with the production, storage, and supply of medical devices: dialysis machines and consumables.
The parties discussed federal and regional government support measures, noting the project's significant importance for ensuring the national security of the healthcare system.
MLT reconstructed its medical device production facility in the Dubna Special Economic Zone for 232 million rubles
MLT, a manufacturer of reagents and laboratory diagnostic equipment and a resident of the Dubna Special Economic Zone (SEZ) in the Moscow Region, completed the reconstruction of its production and warehouse complex for 231.9 million rubles. The company received permission to commission the facility.
According to the regional Ministry of Investment, after the reconstruction, the complex's area increased 1.7-fold – from 375.6 square meters to 643.3 square meters. The facility will develop and manufacture medical devices for in vitro diagnostics, including coagulation, cytology, and histology.
Currently, the MLT enterprise develops and manufactures devices and reagents for studying the hemostasis system. The company's main focus is also the creation of devices and reagents necessary for the preparation of microscopic slides.
Among other things, MLT manufactures automatic staining machines at its plant in the Dubna SEZ. These machines help speed up the preparation of slides for analysis several times while maintaining staining quality. In 2027, the company plans to begin production of automatic slide mounters for hematology, microbiology, cytology, and histology.
Other
Saratov scientists have presented a contactless device for rapid wound assessment
Scientists from the V.I. Razumovsky Saratov State Medical University (SSMU) have developed a device for rapid diagnosis of damaged organs and tissues based on blood flow indicators. According to the university, the device uses laser Doppler flowmetry and allows for contactless assessment of blood flow in small vessels of the skin and mucous membranes, RIA Novosti reports.
In modern practice, laser Doppler flowmetry is considered a fast and safe method for measuring microcirculation, but its use in Russia is limited due to a shortage of modern equipment. The only domestically produced device requires direct contact with tissue, while imported equivalents are bulky, require connection to a computer with specialized software, and require specialized training. Furthermore, they are not free from contact with the wound surface, which can distort results and is undesirable during surgery.
The hardware and software system developed at SSMU addresses these issues: it allows for completely contactless measurements, is based on modern components, and is compact, autonomous, and easy to use for physicians. According to Gleb Mareev, Head of the Otolaryngology Department at SSMU and one of the project's authors, this makes the device convenient for use not only in clinics but also in the field.
The device can be used to assess the extent of burn injuries, the viability of transplanted tissues and grafts, the severity of microvascular disorders in diabetes, and to monitor the condition of the intestinal wall during abdominal surgery. Furthermore, the device can help physicians assess blood flow in the extremities after the application of tourniquets and tourniquets for wounds and injuries caused by combat, man-made disasters, and other emergency situations, and decide on the need for amputation.
New registered medical devices
We publish a list of new medical devices registered from 04.24.2026 to 04.30.2026
Link to the list: [see table in the attachment]
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