News Digest 09.10.2026 — 16.10.2026
Regulators
Validity of the Procedure for Maintaining the Register of Clinical Trials for Medical Devices Extended Through 2028
Roszdravnadzor (the Federal Service for Surveillance in Healthcare) has amended the procedure for maintaining the register of clinical trials for medical devices, which was originally adopted in July 2025. This regulation replaced two previous orders issued by the agency: Order No. 2525 of April 14, 2014, "On Approval of the Procedure for Maintaining the Register of Issued Authorizations for Conducting Clinical Trials of a Medical Device," and Order No. 4220-Pr/13 of August 19, 2013, "On Approval of the Form for Authorization to Conduct Clinical Trials of a Medical Device." The document was originally set to expire on December 31, 2026, but the regulatory authority has extended its validity for an additional two years.
The current procedure outlines the standards for maintaining the register of authorizations granted for conducting clinical trials of medical devices. The database must be kept in an electronic format and include details regarding the authorizations issued for such clinical trials.
The register contains the date and number of the clinical trial authorization, the name of the medical device, its classification according to the nomenclature for medical devices (NKM), its potential risk class, information about the manufacturer and their authorized representative, the place of manufacture, details regarding the clinical trial—including the clinical sites where it was conducted—and the current status of the trial itself.
Information must be entered into the register within three business days of becoming available. Manufacturers or their authorized representatives may report the commencement of clinical trials via their personal accounts on the state services portal (Gosuslugi).
The register remains publicly accessible on the official Roszdravnadzor website. Data must be updated daily, with all previous versions of the register preserved. In February 2024, the Council of the Eurasian Economic Commission updated the rules governing clinical and clinical-laboratory studies for medical device registration. The revised version incorporates parameters for establishing medical device equivalence to validate clinical study results and specifies testing parameters and conditions for *in vitro* diagnostic medical devices and healthcare IT solutions.
Additionally, the document outlines the conditions for obtaining authorization to initiate clinical studies, as well as the requirements and grounds for removing medical facilities from the list of organizations authorized to conduct testing for medical device registration under EAEU rules. These new provisions do not apply to devices currently undergoing registration for which study contracts have already been concluded. The updated procedure for conducting clinical studies entered into force in July 2024.
Ministry of Health Proposes Updating Equipment List for Endocrinology Centers
The Russian Ministry of Health has drafted an order to update the list of medical devices and equipment for regional and inter-district endocrinology centers that provide care to patients with diabetes and carbohydrate metabolism disorders. The document proposes approving a new list of 27 items and repealing the agency's current Order No. 146n, dated March 24, 2025.
According to the explanatory note, the need for this update stems from the issuance of Ministry of Health Order No. 633n, dated October 24, 2025, which established the procedure for providing ophthalmological care to adults. This order dictates the equipment requirements for ophthalmology consulting rooms and laser operating rooms within regional and inter-district endocrinology centers.
The list includes medical devices for patient examination and treatment—such as automatic refractometers, slit lamps, ophthalmoscopes, perimeters, pachymeters, fundus cameras, optical coherence tomography (OCT) scanners, and ophthalmic laser systems—as well as an electric podiatry chair, a portable Doppler ultrasound unit, a medical examination couch, and instrument tables. A pedicure unit is listed under the "other equipment" category.
The document was developed based on the "Combating Diabetes" federal project, which is part of the "Healthcare Development" state program. Proposals from Roszdravnadzor (the Federal Service for Surveillance in Healthcare) and expert input from the agency's National Institute of Quality were taken into account during the drafting process.
Market news
Fetal and Neonatal Care Equipment Market Projected to Grow to $8.13 Billion
The global market for fetal monitoring and neonatal care equipment reached $4.55 billion in 2025 and is projected to grow to $8.13 billion by 2034, according to a forecast by Fortune Business Insights. The market is expected to expand at a compound annual growth rate (CAGR) of 6.7%.
The study covers fetal monitoring systems, incubators and other thermoregulation equipment, respiratory support devices, neonatal monitors, and phototherapy equipment. Analysts identify the need for treating premature infants and high-risk newborns, the expansion of neonatal intensive care units (NICUs), and the modernization of hospital facilities as the primary drivers of demand.
In 2025, the largest market shares were held by GE HealthCare, Drägerwerk AG & Co. KGaA, Koninklijke Philips NV, and Getinge. Fetal monitoring equipment represented the largest product segment in 2025, supported by its routine use in tracking fetal heart rate, uterine activity, and maternal health during pregnancy and labor. Additional demand is being driven by the replacement of aging equipment and the adoption of digital technologies.
In terms of application, neonatal intensive care leads the market; it is projected to account for 39.3% of the market in 2026.
The report identifies the shift from standalone devices to connected systems as a key technological trend. Such solutions enable centralized patient monitoring, the integration of data into electronic health records (EHRs), remote access, and the generation of automated alerts. Digital systems are estimated to hold a 33.9% share of the market in 2026. "Interconnected, remote, and AI-enabled perinatal care will emerge as a key trend," the report states.
In 2025, North America remained the largest regional market, valued at $1.52 billion. Projections for 2026 indicate that the Asia-Pacific market will reach $1.38 billion, while the European market is expected to reach $1.28 billion. The authors note significant gaps in access to modern neonatal care in low- and middle-income countries, where opportunities for sales growth are primarily linked to the development of neonatal infrastructure and government procurement.
At the same time, a shortage of neonatologists, nurses, respiratory therapists, and biomedical engineers may hinder the adoption of medical equipment. Other identified barriers include insufficient budgets, overcrowded hospital units, challenges with technical maintenance, and inadequate infrastructure. In developed markets, declining birth rates present an additional constraint.
PSK Pharma introduces an inhaler featuring a triple-molecule combination for the treatment of bronchial asthma
At the XXXVI National Congress on Respiratory Diseases, PSK Pharma unveiled an original, domestically developed product for the treatment of bronchial asthma. It is a metered-dose dry powder inhaler containing a fixed triple combination of glycopyrronium bromide, indacaterol, and ciclesonide. There are no other drugs in the world with this specific combination of molecules.
According to the Russian Respiratory Society, bronchial asthma causes over 450,000 deaths worldwide each year. Most of these deaths are preventable with proper treatment. Specialists from the National Medical Research Center for Phthisiopulmonology and Infectious Diseases (under the Russian Ministry of Health) estimate that the number of people with asthma in Russia is approaching 10 million, making it one of the most significant chronic diseases for the Russian healthcare system.
To reduce the risks associated with the disease, it is crucial for patients to receive therapy that simultaneously dilates the bronchi and addresses inflammation. This is precisely what the new drug from PSK Pharma is designed to do. Glycopyrronium bromide and indacaterol are two bronchodilators that, when used together, enhance each other's effects and facilitate breathing. Ciclesonide provides the anti-inflammatory action; it is a prodrug that converts into its active form directly within the lung epithelial cells. Consequently, ciclesonide is less likely to cause side effects—such as candidiasis—which significantly improves the quality of life for patients with bronchial asthma.
It is also important that all three components are combined into a single device, eliminating the need for patients to use multiple inhalers. This has a direct and substantial impact on treatment adherence, which is a major challenge in the management of chronic respiratory diseases.
Other
"Allergarda" vaccine will not be available in pharmacies
Once it receives authorization for general medical use, the first registered allergy vaccine will be supplied directly to healthcare facilities, bypassing retail pharmacies. This is expected to take place in November 2026.
The "Allergarda" vaccine will be delivered straight to healthcare institutions; it is not intended for sale through pharmacies, stated Professor Valery Smirnov, Deputy Director of the National Medical Research Center for Allergology and Immunology at the Federal Medical-Biological Agency (FMBA) of Russia, during a lecture as part of the "Metafaza" project, as reported by a correspondent for *MV*.
"Administering this type of product—or any preparation used for allergen-specific immunotherapy (ASIT)—requires the setting of an allergist-immunologist’s office," Valery Smirnov explained.
Patients with a confirmed allergy to birch pollen who visit a medical facility for allergen-specific immunotherapy (ASIT) will be offered the choice between "Allergarda" or traditional ASIT, the FMBA representative noted. The medical facility must also hold a license to perform vaccinations.
Developing an alternative dosage form of the allergy vaccine that might be more convenient for patients—such as an oral formulation—is not feasible. Valery Smirnov explained that this is due to the presence of peptides, which serve as the active ingredients. The protein structure, composed of three peptides, would lose its properties while passing through the gastrointestinal tract.
The expert provided an estimated timeline for when "Allergarda" will become available. According to him, the manufacturer—the company "Generium"—plans to release the vaccine for general medical use in early November. The next allergy vaccine under development targets ragweed allergy, Valery Smirnov explained. Two allergens—Amb a 1 and Amb a 11—have been identified as the triggers for sensitization to ragweed pollen, and a construct for the new vaccine has been created. Animal studies could begin in 2027.
Source: https://medvestnik.ru/content/news/vakcina-allergarda-ne-budet-postupat-v-aptechnuu-set.html
New registered medical devices
We publish a list of new medical devices registered from 10.09.2026 to 10.16.2026
Link to the list: [see table in the attachment]
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