News Digest 17.07.2026 — 24.07.2026
Regulators
The Procedure for Maintaining the Register of Clinical Trials of Medical Devices May Be Extended Until the End of 2028
Roszdravnadzor plans to amend the Procedure for Maintaining the Register of Clinical Trials of Medical Devices, adopted in July 2025. This regulation replaces the regulator's orders No. 2525 of April 14, 2014, "On Approval of the Procedure for Maintaining the Register of Issued Permits to Conduct Clinical Trials of Medical Devices" and No. 4220-Pr/13 of August 19, 2013, "On Approval of the Permit Form for Conducting Clinical Trials of Medical Devices." The document expires on December 31, 2026, but the supervisory authority plans to extend it for another two years.
Public comment on the draft order will continue until August 7, 2026.
The current procedure itself describes the rules for maintaining the register of issued permits to conduct clinical trials of medical devices. The database must be maintained electronically and include information on issued permits to conduct clinical trials of medical devices.
The registry contains the date and number of the permit to conduct a clinical trial of a medical device, the name, the nomenclature classification of medical devices by type (NCMI), the potential risk class, information about the manufacturer and authorized representative, the place of manufacture, information about the clinical trials, including information about the clinics where they were conducted, and the status of the clinical trials themselves.
Information is entered into the registry within three business days of the date the information is released. Manufacturers or authorized representatives can notify the start of trials through their personal account on the public services portal.
The registry remains publicly accessible on the official website of Roszdravnadzor. The data must be updated daily, preserving all previous versions of the registry.
In February 2024, the Council of the Eurasian Economic Commission updated the Rules for Conducting Clinical and Clinical Laboratory Trials during Registration of Medical Devices. The new version includes parameters for determining the equivalence of medical devices for validating clinical trial results and specifies the parameters and conditions for testing in vitro diagnostic medical devices, as well as IT solutions in the healthcare sector.
Furthermore, the document sets out the conditions for obtaining permission to initiate clinical trials, as well as the requirements and grounds for excluding clinics from the specialized list of organizations authorized to conduct trials in the format of medical device registration under EAEU rules. The amendment does not apply to devices currently undergoing registration and for which research contracts have already been concluded. The new version of the clinical trial procedure entered into force in July 2024.
Roszdravnadzor has divided the powers of licensing medical device maintenance with the regions
The Russian Ministry of Health has amended the standard regulations for the territorial office of the Federal Service for Surveillance in Healthcare. According to the amendments to Order No. 844n of August 13, 2020 (the document is available at MV), the powers of the territorial office of Roszdravnadzor have been expanded to include activities related to the maintenance of medical devices, including making changes to the license register and assessing the licensee's compliance with licensing requirements.
Exceptions include cases where maintenance is carried out to meet the in-house needs of a legal entity or individual entrepreneur, as well as when the maintenance involves medical devices with a low potential risk of use.
In February, MV reported that the Russian government had shortened the deadline for amending the register of licenses for the maintenance of medical devices and expanded the powers of Roszdravnadzor's territorial offices. The document stated that the federal service would continue to issue licenses, provide extracts from the registry, and assess applicants' compliance with licensing requirements. The service's territorial offices will be able to independently amend the license registry and assess the compliance of applicants who have submitted documents. If a region lacks a territorial office of Roszdravnadzor, these functions will be assigned to another licensing authority.
The Russian Ministry of Health's decision to transfer authority for licensing medical device maintenance activities from Roszdravnadzor to its territorial offices was announced back in 2024. The draft order was published on August 26 on regulation.gov.ru. The document was developed to ensure compliance with the deadlines for the provision of the state service for licensing medical device maintenance activities and is aimed at increasing its accessibility, territorial consistency, and applicant satisfaction with the quality of the state licensing service, according to the explanatory note.
It has been proposed to extend the rules for labeling medical devices to multi-product sets
The Russian Ministry of Industry and Trade has published a draft government resolution amending the mandatory labeling rules for several product categories. The document introduces the concept of a "multi-product set"—a set combining labeled products from different product groups—and establishes a unified procedure for their registration, labeling, and accounting in the State Information System.
Public comment on the draft will last until August 1, 2026, and an independent anti-corruption review will continue until July 24. In addition to medical devices, similar rules are proposed to be extended to, among other things, personal hygiene products.
The draft defines a set as a collection of labeled products, which may include products subject to different mandatory labeling requirements. Each such set will be assigned its own identification code, and the labeling system must store information about all products included in it.
The document details the procedure for creating sets. Manufacturers and other market participants will be able to create them at any stage of product circulation. However, before placing the kit on sale, they are required to register it in the National Catalog of Labeled Goods and provide the system operator with information about its composition. Registration will require the kit name, product codes, quantity, and other identification data. If information about the labeled medical device included in the kit is missing, the operator will be able to deny registration.
A separate set of changes is dedicated to the traceability of such kits. If at least one medical device from the kit is sold or withdrawn from circulation, the information system will automatically register the dissolution of the entire kit. A similar mechanism is provided for changes to the kit's composition or its re-aggregation. This will maintain continuous product traceability and reduce the number of transactions that market participants must process manually.
In July 2026, the Russian Government approved a procedure for verifying information on medicines, medical devices, dietary supplements, and other categories of goods posted on marketplaces. According to the new rules, digital platform operators are required to verify state registration and product labeling data against state registries and monitoring systems before publishing product cards and whenever they are amended. The document also defines a mechanism for state oversight of compliance with platform economy requirements, which will be implemented by the Federal Antimonopoly Service of Russia.
The State Duma of the Russian Federation approved a mechanism for emergency blocking of hazardous goods through the State Information System for Monitoring and Control (GIS MT)
The State Duma of the Russian Federation adopted Bill No. 1209354-8 "On Amendments to Certain Legislative Acts of the Russian Federation" in its second and third readings. This bill allows regulatory authorities to promptly suspend the sale of products posing a threat to the life and health of citizens, including products with mandatory labeling, through the State Information System for Monitoring and Control (GIS MT).
The amendments are being made to the law on consumer protection, the law on sanitary and epidemiological well-being, the law on technical regulation, the law on trade activities, and the law on state control. These amendments introduce a unified procedure for issuing orders to suspend (prohibit) the sale of products and for enforcing such orders through the state labeling and monitoring system.
If there is a need to urgently restrict the sale of dangerous products, the state control (supervision) agency will be able to issue an order to suspend or prohibit sales, which will be enforced using the State Information System for Products with mandatory labeling. The explanatory note emphasizes that this will reduce the time from the detection of a threat to the actual cessation of sales from several months to just a few hours.
The ban may apply to an individual batch of a product, a specific product name, or all products from a specific manufacturer.
The basis for orders to suspend sales may be:
- Registration of cases of infectious and mass non-infectious diseases (poisoning) associated with the consumption of the product;
- Information from international organizations, EAEU member states, or other countries on the sanitary measures being applied;
- Results of sanitary and epidemiological investigations, occupational diseases, accidents, and incidents;
- Law enforcement data obtained in criminal cases.
To ensure that consumers and market participants are informed, the decision must be posted on the official website of the relevant federal agency and, for labeled products, in the State Information System for Medical Equipment (GIS MT). If the order is not addressed to a specific seller, it becomes mandatory for all sellers selling the specified products.
According to the adopted text, the law as a whole will enter into force on March 1, 2027. An earlier deadline of December 1, 2026, has been set for amendments to the Law "On Circulation of Medicines" concerning the register of documents on the stages of production of medicines in the EAEU.
Market news
A US startup has created a smart ring for people with hypertension
The American startup Vital Signals has unveiled the Signal Ring, a smart ring that, according to its developers, can continuously measure blood pressure without a cuff or regular calibration. The device is not aimed at fitness, but at people with hypertension and cardiovascular disease, for whom pressure monitoring can be critical, as reported by Engadget.
The idea for the project emerged after the company's founder, Tom Moss, was hospitalized with a systolic blood pressure of 250 mmHg. Together with engineers from Masimo, he spent three years developing the Signal Ring algorithms, which uses optical sensors and, according to the company, can measure pressure with an accuracy comparable to a traditional cuff.
The optical sensor monitors the pulse wave: how the blood volume in the artery increases and decreases with each heartbeat. It reads the waveform and measures its intensity to estimate blood pressure. The Vital Signals website claims that the Signal Ring reads blood flow 4-5 times faster than sensors in other contactless trackers, in part due to its high resolution.
The Signal Ring operates in two modes: it passively tracks blood pressure and sleep patterns, and it also allows for manual measurements in controlled environments. Users can add context to the results—for example, by specifying physical activity, coffee, food, or smoking—to better understand what influences blood pressure. The manufacturer emphasizes that it has eliminated subscriptions and built-in artificial intelligence, focusing on accuracy and data export for further analysis. The company is still seeking regulatory approval and has not ruled out partnerships with insurance companies.
Pre-orders for the Signal Ring are now open for $399, with shipments planned for October, initially in the US only. The device is claimed to last up to three days without recharging.
Other
Rospotrebnadzor (Rospotrebnadzor) has requested information from the Turkish Ministry of Health regarding the Coxsackievirus outbreak in Antalya
The Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing of the Russian Federation (Rospotrebnadzor) has sent inquiries to the Turkish Ministry of Health and the Association of Tour Operators of Russia (ATOR) regarding reports of the spread of Coxsackievirus among Russian tourists at the Belek resort in Antalya Province.
Earlier, Telegram channels reported that Russians encountered problems while vacationing at the Turkish IC Santai Family Resort. Relevant authorities in Antalya have not confirmed this information. The Russian Consulate General in Turkey has also not received any complaints from Russian citizens regarding poisonings.
Rospotrebnadzor has requested information from the Turkish Ministry of Health regarding the results of the investigation and an assessment of the risk of a possible worsening of the epidemiological situation.
In the fall of 2024, Russians vacationing in Antalya Province began seeking medical attention en masse for illness caused by the Coxsackievirus. Experts noted that these were localized outbreaks that occurred in resort areas and children's health camps every season. Later, several imported cases were confirmed among children in Russian schools in several regions, including Moscow, the Moscow region, Kuban, and Tatarstan.
Study: Sugar substitutes in combination with medications alter the gut microbiota
Scientists from the University of Cambridge (UK) presented a study in the journal Springer Nature that found that low-calorie sweeteners can directly influence the growth of bacteria in the gut microbiota, and when combined with certain medications and other commonly consumed substances, they can significantly enhance or weaken this effect. The study identified over 100 previously undescribed interactions between sweeteners, xenobiotics, and gut microorganisms that can influence the composition of the gut microbiota and the body's immune response. Researchers tested 39 natural and synthetic sweeteners on 25 bacterial strains representative of healthy human microbiota. They also assessed the effects of combinations of sweeteners with a number of commonly used substances, including caffeine, vanillin, the antidepressant duloxetine, and eight medications that often contain sweeteners to mask bitter taste.
The study identified 30 direct interactions between sweeteners and gut bacteria. Clostridium symbiosum and Lacrimispora saccharolytica were found to be the most sensitive. The most active compound was isosteviol, derived from stevia, which inhibited the growth of three bacterial species while simultaneously stimulating the growth of Lactobacillus gasseri.
An analysis of combinations of sweeteners with other substances revealed 102 interactions, 68 of which were antagonistic and 34 synergistic. The researchers observed the most pronounced synergistic effect with the combined action of isosteviol and duloxetine on the bacterium Roseburia intestinalis, which is associated with intestinal health and a reduced risk of inflammatory diseases.
To assess the effects of the combinations, the researchers created a synthetic model of the intestinal microbiota. Combined action of isosteviol and duloxetine resulted in the most pronounced reduction in bacterial community diversity compared to the action of either substance alone. Concurrently, the abundance of a number of beneficial microorganisms, including Roseburia intestinalis, Parabacteroides merdae, Bacteroides uniformis, and other representatives of normal microflora, decreased.
According to the researchers, the observed changes may indicate the potential influence of the combination of sweeteners and medications on immune regulation via the microbiota. The authors emphasize that the obtained results are based on in vitro experiments and require confirmation in human studies.
In mid-February 2026, the International Sugar Organization released data showing that sugar consumption in Western Europe had fallen by 6.7% over the past two years, and by 4.4% in the United States. Analysts attribute this trend to the proliferation of weight-loss drugs and the introduction of taxes on sugary drinks in several countries. Manufacturers are being forced to reduce the sugar content of their products, including by adding sweeteners.
The WHO has called on European countries to strengthen mosquito control measures due to West Nile virus
The World Health Organization (WHO) Regional Office for Europe has called on countries to strengthen mosquito monitoring and public awareness of protective measures amid the increasing seasonal activity of the West Nile virus. According to the regional office (a letter obtained by MV), the number of infections is rising in several countries across the continent, and the transmission season is just beginning.
The highest number of cases is currently being recorded in Greece and Italy. In Greece, 21 cases have been confirmed in a short period of time, 14 of which were confirmed in the past week alone. Most patients suffered from neuroinvasive forms of the disease, including encephalitis and meningitis. In Italy, the virus has already been detected in 17 regions, indicating a wide geographic spread of the infection. Human cases have also been reported in Spain, Romania, and North Macedonia.
West Nile virus is transmitted through the bites of infected mosquitoes, and peak incidence in Europe typically occurs between July and September. There is no specific vaccine for humans or antiviral treatment, so patient care is limited to symptom relief and supportive care in severe cases. While the disease is typically mild, approximately 1 in 150 people infected with the virus develops a severe form, which affects the central nervous system and can be life-threatening.
The WHO emphasizes that the risk for most people remains low, but if fever, rash, headache, neck stiffness, or other worrying symptoms develop after a mosquito bite, seek immediate medical attention. Experts recommend using repellents, wearing protective clothing, installing window screens, and removing standing water near homes to reduce mosquito populations.
In 2024, World Health Organization Director-General Tedros Adhanom Ghebreyesus warned that it was only a matter of time before a new pandemic emerged. The WHO included West Nile fever in its list of pathogens capable of causing a large-scale epidemic. In Russia, cases of West Nile fever were recorded in 22 regions that year. The highest number was in Tatarstan: 59 people were diagnosed with the disease, 58 of whom were hospitalized.
New registered medical devices
We publish a list of new medical devices registered from 07.17.2026 to 07.24.2026
Link to the list: [see table in the attachment]
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