News Digest 11.09.2026 — 18.09.2026
Regulators
Roszdravnadzor Updates Administrative Regulations for Medical Device Registration
Roszdravnadzor has approved new administrative regulations for the provision of the state service for medical device registration. The scope of eligible applicants has been clarified, timeframes have been adjusted, and grounds for refusal have been introduced. The new regulations will remain in effect until the end of 2028.
Roszdravnadzor has approved new Administrative Regulations for the provision of the state service "State Registration of Medical Devices." Order No. 750, dated August 19, 2026, has been published on the legal information portal.
This document replaces the regulations approved by Order No. 3371, dated May 6, 2019.
Under the new regulations, the medical device developer is no longer designated as an independent applicant; only the manufacturer and its authorized representative may apply for the service. The service now results in a registry entry in the State Register of Medical Devices, rather than the issuance of a separate document.
Timeframes for several procedures have also changed:
- registration of medical devices without clinical trials: 31 working days (down from 35);
- domestic products: 10 working days; software with artificial intelligence: 10 working days;
- making amendments without expert review: 18 working days (up from 15);
- making amendments with expert review: 36 working days (up from 35);
- cancellation of registration: 7 working days (up from 3).
The new regulations introduce a list of grounds for refusing to provide the service, such as a conclusion that clinical trials or registration are not feasible, identified discrepancies regarding efficacy and safety data, or the inability to amend the registration dossier.
The new regulations are effective until the end of 2028.
Rules for state procurement of CGM systems to change
The Russian Ministry of Health has drafted amendments to the "Healthcare Development" state program regarding procurement rules for continuous glucose monitoring (CGM) systems. Specifically, when calculating the federal budget subsidy for their purchase, the regulator proposes removing coefficients from the formula that account for maximum wholesale markups established for implantable medical devices—since CGM systems do not fall into this category. Additionally, the agency has proposed a revised formula for determining the required volume of CGM systems for pregnant women.
Currently, the coefficients K1i and Ki reflect maximum wholesale markup limits established under the government decree on price regulation for medical devices implanted in the human body during the provision of care under the state guarantee program. The explanatory note accompanying the draft document states that these coefficients must be excluded because CGM systems are not classified as such implantable medical devices and do not appear on the relevant list.
"Consequently, continuous glucose monitoring systems are not subject to state price regulation regarding maximum wholesale markups. Applying the K1i and Ki coefficients when calculating subsidies for the purchase of these devices is incorrect, and they should be removed from the state program," the explanatory note clarifies.
The draft government decree developed by the Ministry of Health also updates the formula for calculating the federal budget subsidy used to purchase CGM systems for pregnant women. This decision was made "to differentiate the need for continuous glucose monitoring systems based on the type of diabetes." If approved, the document will enter into force on January 1, 2027.
Source: https://vademec.ru/news/2026/09/17/pravila-goszakupok-sistem-nmg-izmenyatsya/
Market news
Russian Ophthalmology Market Reaches 96 Million Consultations Per Year
Between 2021 and 2025, the volume of the ophthalmology market in Russia grew by 11.5%, rising from 86 million to 96 million consultations. These figures come from the analytical agency BusinesStat. Market dynamics are influenced by demographic, behavioral, regulatory, and technological factors.
Rising life expectancy, an aging population, and the widespread use of electronic devices are driving up the incidence of eye conditions across both younger and older age groups, thereby increasing the demand for ophthalmological services.
Service accessibility is expanding due to increased care provision in the public sector—supported by the State Guarantee Program and national projects—as well as advancements in vision correction and eye disease treatment technologies and a broader range of services offered by private clinics. At the same time, the average cost of an ophthalmological consultation rose by 39% between 2019 and 2023, increasing from 2,740 to 3,810 rubles.
This price increase was primarily driven by rising costs in the commercial sector, where surgical procedures account for a larger share of services. In contrast, the public sector is dominated by outpatient consultations, for which rates increased more slowly.
Analysts note that while foreign medical device suppliers temporarily restricted cooperation in 2022—leading to disruptions and higher costs for imported equipment and consumables—ophthalmological organizations have since adapted by adjusting logistics routes and supplier relationships.
Source: https://medvestnik.ru/content/news/rossiiskii-rynok-oftalmologii-dostig-96-mln-priemov-v-god.html
Other
Live Aujeszky’s Disease Virus Found in "Multican-8" Vaccine Batch
Live Aujeszky’s disease virus has been detected in samples from batch No. 20 of the "Multican-8" vaccine, collected in the Yaroslavl region. RBC reported the test results from the All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed (VGNKI), citing the press service of Rosselkhoznadzor (the Federal Service for Veterinary and Phytosanitary Surveillance).
"Thus, a causal link has been confirmed between mass fatalities among dogs and their immunization with 'Multican-8' vaccine batch No. 20, which was contaminated with a foreign virus lethal to this animal species," the agency stated.
The vaccine in question is manufactured by Vetbiokhim LLC. Rosselkhoznadzor had previously ordered the withdrawal of this batch of the veterinary drug from circulation, followed by its destruction.
In August, media reports emerged regarding post-vaccination health complications in dogs treated with "Multican-8." A veterinary center in Yaroslavl announced it had stopped using the drug as of August 14. The manufacturer launched an investigation and suggested that the deaths of dogs in the Yaroslavl region might have resulted from malicious interference by third parties.
According to Rosselkhoznadzor, complaints regarding serious adverse reactions to the vaccine were also received from the Leningrad, Tula, Penza, Saratov, Belgorod, and Moscow regions. Reports were also recorded in Moscow, St. Petersburg, and the Kuban region.
Separately, a report was received regarding the death of a cat following the use of "Multifel"; samples are currently being tested.
New registered medical devices
We publish a list of new medical devices registered from 09.11.2026 to 09.18.2026
Link to the list: [see table in the attachment]
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