News Digest 01.11.2025 — 07.11.2025
Regulators
The Russian Association of Pharmacy Chains (RAAC) has called for the introduction of labeling for another group of products
The Russian Association of Pharmacy Chains (RAAC) has proposed accelerating the experiment on labeling medical devices and including new product groups. The "gray" market for fillers and products for biorevitalization, mesotherapy, and thread lifting continues to grow on online platforms and is not regulated in any way.
A number of medical device groups have "gone underground" and are freely sold on marketplaces and other online platforms, posing direct risks to the lives and health of consumers and facilitating the spread of counterfeit products, Alexander Oparin, Executive Director of the Association, told a FV correspondent following a meeting of the Council for Consumer Market Development of the Chamber of Commerce and Industry of the Russian Federation. Labeling for a number of medical devices is currently in the experimental phase.
"It needs to be brought into the industrial arena, as a large-scale gray market is growing outside of the civilized retail sector. In particular, medical devices used in cosmetology are sold on many online platforms under the guise of anything but medical devices. These products can only be safely used in specialized centers, but the free sale of these products is leading to the development of a home-based market. This poses serious risks to the population," explained Alexander Oparin.
In a discussion with Revaz Yusupov, Deputy General Director of CRPT (operator of the Honest Sign labeling system), it was decided to submit proposals from RAAS to expand the list of medical devices subject to mandatory labeling.
"This will allow us to demonstrate market volumes, track the product's journey from manufacturer to end consumer, and quickly identify violators," noted Alexander Oparin.
According to the company "Right to Health," an increasing number of unregistered, counterfeit, and fake medical devices in the cosmetology sector are being identified on the market each year, Forbes Healthcare reported in March.
Of the 127 fillers on the market in 2024, only 69% had a medical device registration certificate from Roszdravnadzor. In the biorevitalizer segment, this share is 53% (133 brands in total), according to analysts at Right to Health.
The VAT payment threshold for simplified taxation systems will be lowered in stages
Russian Prime Minister Mikhail Mishustin announced a phased transition for small businesses to VAT payments at a government meeting. He noted that during the extensive discussion, proposals for changes to tax legislation were received from deputies, senators, representatives of the business and expert communities, and public organizations. These proposals have been taken into account, Mishustin said.
"The conditions for applying VAT for small and medium-sized businesses will be relaxed. The payment thresholds will be gradually adjusted: starting in 2026, for revenues of 20 million rubles; starting in 2027, for 15 million rubles; and starting in 2028, for 10 million rubles. At the same time, given the government's authority, to eliminate potential risks, a moratorium on prosecution may be established for taxpayers who violate VAT payments for the first time under the new regulations," the prime minister noted.
At the end of October, the State Duma of the Russian Federation adopted amendments to Parts I and II of the Tax Code of the Russian Federation in their first reading. These amendments reduced the annual revenue threshold for companies operating under the simplified taxation system (STS) from 60 million to 10 million rubles. This decision was intended to prevent business fragmentation and was projected to generate approximately 200 billion rubles annually for the budget. A similar threshold reduction under the patent taxation system would generate an additional 7.668 billion rubles over three years.
All legal entities exceeding the 20 million ruble revenue threshold in 2025, starting from the first ruble in 2026, will be obligated to pay VAT, noted Viktor Ivanitsky, partner at the Capital Audit Group, speaking at the Pyatigorsk Discussion Club.
He noted that businesses are also awaiting a reform of insurance premiums. Currently, SMEs (with annual revenue of up to 2 billion rubles and up to 250 employees) pay insurance premiums at a rate of 15% above 1.5 times the minimum wage, and 30% below that amount.
"Starting next year, the government will establish a list of OKVED (All-Russian Classifier of Economic Activities) classifications for which the same system can be applied; for others, the rate will be 30%. Whether retail sale of pharmaceuticals will be included in this list is an open question," the auditor said.
According to him, some market participants are considering the automated simplified taxation system (ASTS), as it allows for the exemption from VAT until turnover reaches 60 million rubles. However, the system limits the number of employees to five and fixed assets to 150 million rubles. The net profit tax rate will be 20%, but not less than 3% of income; the income-based rate is 8%. However, many questions arise when businesses transition to the ASTS from other tax regimes, said Viktor Ivanitsky.
Market news
Russia's first dialysis equipment manufacturing plant is scheduled to open in March
Kaluga Region Governor Vladislav Shapsha held a working meeting with Nikolai Panikarovsky and Alexey Kataev, CEOs of Pharmasyntez-Medtech and Novadial. The governor reviewed the progress of this large-scale project—the creation of Russia's first plant for the production of medical equipment and hemodialysis products—and saw prototypes of products manufactured at the Kaluga facility.
Investment in the plant is estimated at 2 billion rubles. Construction and renovation work in the production facilities has been completed, the installation of process equipment is underway, and comprehensive technical testing is underway. The next step will be product registration with Roszdravnadzor. The plant is scheduled to open in March 2026.
Production will be carried out under the Novadial brand. The plant will eventually become the country's first industrial site capable of fully satisfying domestic demand for high-tech equipment and consumables for hemodialysis and peritoneal dialysis. The meeting participants emphasized that the project will not only provide patients with modern domestic equipment but also create new jobs, strengthen the region's industrial potential, and make a significant contribution to the development of the Russian medical industry.
Experts predict the size of the medical technology market in Russia and globally by 2030
The global medical technology market reached $734 billion in 2024 and will grow at a compound annual growth rate of approximately 11%, approaching $1.4 trillion by 2030. In Russia, this sector is also demonstrating rapid growth and will grow by an average of 14% annually in the medium term, according to analysts from Technologies of Trust (formerly PwC).
If this trend continues, the size of the Russian medical technology market will increase by 2030 from last year's 1 trillion rubles. The global medical technology market is expected to grow from 2.3 trillion rubles ($13.4 billion) to 2.3 trillion rubles ($28.8 billion), accounting for 2.12% of the global total. This is driven by increased government spending on healthcare, localization programs, and growing demand for high-tech solutions, according to the report.
Approximately half of the global medical technology market (47%) is comprised of five major segments: assistive technologies (13%), in vitro diagnostics (11%), cardiology equipment (10%), diagnostic imaging equipment (7%), and virtual medicine (6%). Segments related to digitalization and improving quality of life are experiencing the greatest growth. Analysts predict a 29% annual growth rate for virtual medicine, and approximately 14% for assistive technologies.
In Russia, the assistive technology market is estimated at 123 billion rubles, and is projected to reach 311 billion rubles by 2030. ($3.8 billion), representing 4.56% of the global market. Growth drivers include an aging population, the impact of military conflicts, expanding government support, and the introduction of digital and automated solutions.
By 2030, experts expect the market structure to shift in favor of the neuro- and cognitive-function segment, which will grow by an average of 22% annually and increase its share to 39%. The mobility segment will maintain growth at 12%, accounting for approximately 41% of the market.
In the first half of 2025, the Russian medical technology market generated 27.6 billion rubles, according to MV. SberZdorovye led in revenue, while the fastest-growing company was bionic prosthetics manufacturer Steplife (699% year-on-year). The psychological center YouTalk also made it into the top three in this ranking.
Among the notable trends in the medical technology market, experts note companies investing in their own digital ecosystems and IT infrastructure, developing AI assistants, and strengthening partnerships. At the same time, a lack of venture capital funding and stricter advertising requirements are hindering the launch of new projects.
Source: https://medvestnik.ru/content/news/Nazvan-obem-rynka-medteha-v-Rossii-k-2030-godu.html
Other
An Expert Council is initiating the creation of unified clinical guidelines for acute respiratory viral infections and influenza in the Eurasian region
A meeting of the International Expert Council was held in Bukhara, Uzbekistan, attended by leading healthcare specialists from Russia, Kazakhstan, Armenia, Azerbaijan, Belarus, Kyrgyzstan, Tajikistan, and Uzbekistan. Following the meeting, a resolution was adopted establishing the initiation of large-scale work to develop unified international clinical guidelines (UICG) for the diagnosis and treatment of acute respiratory viral infections and influenza in adults and children. Binnopharm Group, a leading Russian pharmaceutical company, supported the implementation of this initiative.
The project aims to address systemic problems common to healthcare in the region: a high disease burden, insufficient etiological diagnosis, fragmented regulatory documents, and the problem of irrational use of antibiotics.
By standardizing approaches, a single document—clinical guidelines based on the principles of evidence-based medicine—will be developed. This will unify the diagnosis and treatment of acute respiratory viral infections and influenza in both hospitals and outpatient clinics, reducing diagnostic errors and unnecessary prescriptions. The document will place particular emphasis on the implementation of accessible rapid diagnostic methods (tests for influenza, COVID-19, and RSV) to accurately identify the pathogen and prescribe targeted therapy.
The international GRADE system will be used in developing the recommendations, ensuring the transparency and scientific validity of all proposed treatment methods. The document will be developed with regional specifics in mind: for each participating country, it is planned to create national annexes to the EICR, which will take into account the availability of specific medications and the economic aspects of therapy.
The standing working group will prepare the first draft of the Consolidated International Clinical Guidelines by March 1, 2026. Following discussion with experts, the final version of the document will be submitted for approval to the Expert Council in May 2026.
An expert stated that government support for the development of medical tourism in Russia is insufficient
Russia is ready to welcome medical tourists thanks to attractive prices for foreigners, its technological base, and the level of its specialists. The lack of reliable statistics, insufficient cooperation between the private and public sectors, and other barriers, which Irina Zalomnova, CEO of Medscan Regions and Head of Medical Tourism at Medscan Group, discussed at the MedMaps conference, MV reports.
By 2034, the medical tourism market in Russia is projected to grow to $3.5 billion (compared to $0.8 billion in 2023). The share of state-funded healthcare will be high, in part due to affordable prices and active promotion. However, the expert believes that government and business should collaborate, not compete. Each clinic should work not only on its own brand abroad, but also on the country's overall image. It might be useful to create a platform showcasing medical services for foreigners, combining offers from both private and public organizations, the speaker concluded.
At the same time, the state lacks the resources to address the service component: welcoming tourists, arranging their leisure time, choosing a clinic and doctor, providing information, and resolving visa, financial, and transportation issues. Service—that is, assistance with these issues—helps patients decide to seek treatment abroad. This component could become a strength for private clinics, allowing them to capture a 2 to 10% market share.
The costs of in vitro fertilization, coronary artery bypass grafting, and joint replacement in Russia are several times lower than in Israel. The cost of a course of cancer treatment of comparable quality is 40-60% lower than in Western Europe. And compared to the US, many procedures are dozens of times cheaper in Russia. Promising areas for tourists include oncology (from diagnostics to nuclear therapy), ophthalmology, assisted reproductive technologies, cardiovascular surgery, ENT surgery, and traumatology/orthopedics. Dentistry and plastic surgery are also joining these areas globally.
However, Russia ranks 41st globally in terms of attractiveness for medical tourists, Irina Zalomnova noted. Government support could improve the situation. For example, in Turkey, the government covered 70-80% of marketing costs in other countries to develop the sector, reduced taxes, and reimbursed transportation costs for medical tourists. Turkey also introduced certification for agents and required them to enter all data into a single digital platform, addressing the lack of reliable statistics.
The Russian Ministry of Health plans to use service companies to increase the flow of medical tourists and invest in the national economy, MV reported. This will ensure that there is no disruption to the provision of medical care to citizens. By December 1, the Central Research Institute of Healthcare Organization and Informatization must prepare draft guidelines for the export of medical services for medical institutions.
New registered medical devices
We publish a list of new medical devices registered from 11.01.2025 to 11.07.2025
Link to the list: [see table in the attachment]
News
