News Digest 25.09.2026 — 02.10.2026
Regulators
EEC Council Amends Medical Device Registration Rules
The Council of the Eurasian Economic Commission (EEC) has amended the Rules for the Registration and Expert Assessment of the Safety, Quality, and Efficacy of Medical Devices (approved by EEC Council Decision No. 46 dated February 12, 2016). Decision No. 104, dated September 9, 2026, has been published on the legal portal of the Eurasian Economic Union (EAEU).
Clause 114 of the Rules is supplemented with a new sub-clause (g): the absence of a valid manufacturing inspection report in the registration dossier will constitute grounds for refusing the registration of a medical device. Exceptions are made for two categories:
- Class 1 medical devices (based on potential risk of use);
- Non-sterile Class 2a medical devices (based on potential risk of use).
A manufacturing inspection report will not be required for these categories.
Previously, the Russian Ministry of Health prepared a draft order to repeal the Administrative Regulations of Roszdravnadzor regarding medical device registration. A new regulation will replace the 2017 document.
Source: https://pharmvestnik.ru/content/news/sovet-eek-vnes-izmeneniya-v-pravila-registracii-medizdelii.html
List of Foreign Medical Devices Subject to Procurement Restrictions to Expand in October
The Russian Government has adopted a decree expanding—by three items, effective October 2026—the list of foreign-made medical devices subject to procurement restrictions for state and municipal needs. The document amends Decree No. 1875 (dated December 2024) regarding measures to apply national treatment in state and corporate procurement. Specifically, three new items have been added to the list: standard balloon catheters for angioplasty, bare-metal coronary artery stents, and drug-eluting coronary artery stents.
Resolution No. 1875, which is being amended, establishes three market protection mechanisms for Russian goods and services: a ban, a preference, and a restriction. The first entails a total ban on the procurement of foreign goods listed in the document's corresponding appendix. The preference establishes a price advantage for domestic goods: for ranking purposes, the price of a bid offering only Russian goods is notionally reduced by 15%. The restriction applies the "second-is-out" rule to goods listed in the appendix: if at least one bid offering Russian goods is submitted for a tender, all bids offering foreign products are rejected. It is this specific appendix that will be expanded to include the three new items in October of this year.
In September 2026, the Russian Ministry of Finance prepared a draft containing further amendments to Resolution No. 1875. The agency proposed changing the procedure for verifying the Russian origin of products manufactured by institutions and enterprises within the penal system, expanding the list of exceptions to the resolution's restrictions, and clarifying the mechanism for confirming the feasibility of manufacturing the procured goods in Russia. Resolution No. 1875 applies to certain types of medical products, among others.
The Ministry of Finance also proposes establishing a mechanism to withhold bid security in cases of repeated bid rejection. If, within a single quarter, three or more bids from the same participant are rejected on grounds specified in the draft, the security deposit for every third such bid will be transferred to the procuring entity. Rejection decisions subsequently ruled unlawful by a court or an antimonopoly authority will not be counted. The project is currently at the stage of summarizing the results of the public consultation.
Government Raises Import Duties on Dietary Supplements from Unfriendly Countries to 35%
Starting October 2, 2026, import duties on dietary supplements (biologically active additives) from "unfriendly" countries will rise from 12% to 35% of their customs value. The Russian Government has adopted a decree to this effect. Hungary and Slovakia are exempt from this measure. The duty will apply to dietary supplements in consumer packaging that bear mandatory identification markings. The decision will remain in effect until the end of 2027.
The new document, published in late September 2026, amends Russian Government Decree No. 2240 of December 7, 2022, "On Approving Import Customs Duty Rates for Certain Goods Originating from States and Territories Taking Measures That Violate the Economic Interests of the Russian Federation."
In June 2025, the Russian Government had already amended Decree No. 2240. At that time, dietary products for medical and preventive use (such as the "Resource Junior" formula from the Swiss company Nestlé Health Science) were removed from the list of goods subject to elevated customs duties when imported from countries "taking measures that violate the economic interests of the Russian Federation." Previously, the exemption from these duties applied only to baby food.
Market news
Global Radiology Services Market Projected to Grow 1.5-Fold by 2034
The global radiology services market was valued at $222 billion in 2025. It is projected to grow at least 1.5-fold—reaching $350.54 billion—by 2034, reflecting a compound annual growth rate (CAGR) of 5.2%, according to a report by the analytics firm Fortune Business Insights. The market encompasses medical imaging procedures such as fluoroscopy, computed tomography (CT), and magnetic resonance imaging (MRI).
Market growth is driven by the rising prevalence of chronic diseases, increasing demand for imaging technologies, higher healthcare spending, an aging population, the adoption of artificial intelligence (AI), and advancements in diagnostic and interventional radiology. Key market players include RadNet Inc., Radiology Partners, I-MED Radiology, LUMEXA IMAGING, INC., Sonic Healthcare Limited, UNILABS, Alliance Medical, Lumus Imaging, SimonMed, and RAYUS Radiology.
Analysts highlight the growing importance of AI in radiology workflows. Healthcare organizations are seeking to manage increasing image volumes, improve operational efficiency, accelerate image interpretation, and ensure more consistent clinical decision-making. AI-powered tools are being integrated across the entire workflow—from worklist prioritization, image acquisition and reconstruction, and anomaly detection to image segmentation and quantification, diagnostic support, structured reporting, and process automation. In 2025, the diagnostic imaging and image interpretation segment held the largest market share by service type; the adult patient segment dominated by age group; the radiography and fluoroscopy segment by imaging modality; and the abdominal and gastrointestinal imaging segment by clinical specialty.
A shortage of qualified personnel remains the primary limiting factor. According to 2026 data from 5C Network Private Limited, there is only one radiologist per 100,000 people in India. Other barriers include government budget constraints, regulatory requirements, and cybersecurity concerns.
Other
Mikhail Murashko Attends 75th Anniversary Celebration of Roszdravnadzor’s VNIIIMT
Russian Minister of Health Mikhail Murashko attended a ceremony marking the 75th anniversary of the All-Russian Scientific Research and Testing Institute of Medical Technology (VNIIIMT) under Roszdravnadzor. The Minister congratulated the institute’s staff on the milestone and highlighted the importance of its work for the development of the domestic healthcare sector and for ensuring the quality, safety, and efficacy of medical devices.
During the ceremony, Mikhail Murashko presented state and departmental awards to staff members in recognition of their achievements in healthcare, years of dedicated service, and contributions to the industry's development. Igor Ivanov, Director General of VNIIIMT, was awarded the Pirogov Order. Other staff members received the "For Merits to Domestic Healthcare" medal, the Ivan Petrovich Pavlov Medal, the "For Assistance in Health Protection" medal, the "Excellence in Healthcare" badge, and certificates of honor from the Russian Ministry of Health.
For 75 years, VNIIIMT has played a key role in developing the scientific, testing, expert, and metrological infrastructure for medical devices. The institute’s work focuses on ensuring the quality, safety, and efficacy of medical technologies introduced into the healthcare system.
The anniversary program concluded with a theatrical performance titled "Safety Angels: Invisible Protection," honoring the specialists who ensure the safety of medical devices throughout their entire lifecycle—from development and testing to actual use in medical facilities. The performance served as a symbolic finale to the evening, underscoring the institute’s mission: to foster the development of safe, high-quality, and effective medical technologies to protect the lives and health of citizens.
Russia Registers World’s First Recombinant Allergy Vaccine
"Allergarda," the world’s first recombinant allergy vaccine for treating birch pollen allergy, has been registered. The treatment course consists of five injections.
The "Allergarda" recombinant allergy vaccine has received a temporary registration certificate from Russia’s Federal Medical-Biological Agency (FMBA). The drug was developed by specialists from the National Medical Research Center for Allergology and Immunology and the company Generium, the FMBA press service reported.
"Allergarda" is intended for adult patients with confirmed birch pollen allergy, seasonal allergic rhinitis, and conjunctivitis. The drug can also be used for cross-reactive food allergies associated with birch pollen sensitization—specifically, reactions to apples, pears, peaches, soy, and peanuts. Where medically indicated, the therapy can be used not only to control allergy symptoms but also to reduce the risk of the condition progressing and the development of bronchial asthma.
Obtaining the temporary registration certificate will allow the drug to be used in Russian medical facilities. It is expected that tens of thousands of patients will be able to receive the vaccine as early as this autumn.
Unlike traditional allergen-specific immunotherapy, "Allergarda" was created using recombinant technology. The drug is based on specific structural components of the allergen rather than the whole protein or a natural allergenic extract. This approach allows for the standardization of the vaccine's composition and more precise control over the dosage of active ingredients.
According to the developers, clinical trials showed that 25% of patients were completely free of allergy symptoms. Among the remaining participants, the severity of symptoms decreased sixfold during the 2025 pollen season and sevenfold in 2026. Furthermore, all patients exhibited a significant increase in protective IgG antibody levels.
The treatment course with "Allergarda" consists of five subcutaneous injections, as opposed to the 30 procedures required by traditional allergen-specific immunotherapy (ASIT). Clinical trials revealed no serious adverse events, and the drug's safety profile was assessed as favorable. The vaccine is intended for patients over the age of 18 and must be administered only under the direction of an allergist-immunologist. Injections are performed at a medical facility under the supervision of a specialist.
New registered medical devices
We publish a list of new medical devices registered from 09.25.2026 to 10.02.2026
Link to the list: [see table in the attachment]
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