News Digest 14.11.2025 — 21.11.2025
Regulators
Roszdravnadzor has developed regulations for issuing extracts from the state register of medical devices
Roszdravnadzor has submitted for public comment a draft order approving administrative regulations for issuing extracts from the state register of medical devices and organizations (individual entrepreneurs) engaged in their production and manufacturing. According to the document, applicants for extracts may be individuals, legal entities, or individual entrepreneurs. The service will also be available by proxy. If adopted, the order will be in effect until March 1, 2028.
The regulations will outline the procedure and standards for issuing extracts from the state register of medical devices and their manufacturers. Roszdravnadzor will issue extracts within five business days of registering the application and documents required for the service. The extract will be issued electronically, and an application and power of attorney are required to obtain it. The original application and a copy of the power of attorney must be sent by mail, or you can send the original application and a copy of the power of attorney electronically through the Unified Portal of State and Municipal Services.
Under the current regulatory framework, there are no grounds for refusing to accept an application and documents for obtaining an extract. There are also no grounds for suspending the service. However, an extract may be denied in certain cases: if the application contains incomplete information or is illegible; if the applicant has not submitted the application and power of attorney; or if the documents are submitted by an unauthorized person. Furthermore, an extract will be denied if it does not comply with the rules for maintaining the state register of medical devices and their manufacturers, or if the request for an extract was not signed with an enhanced qualified or unqualified electronic signature.
The draft order also contains the application form and documents required to obtain an extract from the register.
In October 2021, the Russian Government approved updated Rules for Maintaining the State Register of Medical Devices and Their Manufacturers. Since March 1, 2022, it has been updated to include photographs of medical devices or interface screenshots for software, as well as electronic versions of documentation or operating instructions. The registry has become fully electronic, and market participants can receive extracts from it within five days.
Roszdravnadzor has changed its decision on vending machines
Roszdravnadzor has changed its decision on vending machines. This was stated in a response to a request from the Union of Vending Machine Operators (SOTA), signed by Georgy Sokolov, Head of the Department for the Organization of State Control and Registration of Medical Devices (available to FV).
In September, Roszdravnadzor sent a letter to regional authorities prohibiting the sale of medical devices and medications through vending machines.
"According to paragraph 7 of the Rules for the Sale of Goods under Retail Sales Agreements, approved by Russian Government Resolution No. 2463 of December 31, 2020, the sale of medicinal products and medical devices is prohibited in retail sales at the consumer's location outside of retail outlets, where the consumer is directly exposed to the product (at home, at work or school, on public transport, on the street, and elsewhere)," the service stated in the letter sent to regional authorities.
This letter was "cancelled by Roszdravnadzor with regard to the circulation of medical devices." No further clarification was received regarding the possibility of selling medicinal products through vending machines.
The clarifications are due to "numerous inquiries from legal entities and individual entrepreneurs regarding the sale of medical devices and medications through vending machines," the document noted. SOTA thanked its colleagues from the Russian Ministry of Health and Roszdravnadzor for their prompt and detailed review of the issue of selling medical products through vending machines.
"The implementation and use of automated service technologies, in our opinion, allows us to solve two important problems: staff shortages and meeting urgent demand (for example, for medical masks and contact lenses) where it arises," Ivan Popov, chairman of the union's board, commented on the supervisory authority's decision to FV.
He added that it is important to avoid additional risks for consumers.
As of September 2025, more than 1,000 contact lens vending machines were operating in Russia. Last year, SOTA reported, they sold more than 500,000 packages of contact lenses and solutions for cleaning and storing them.
Source: https://pharmvestnik.ru/content/news/roszdravnadzor-pomenyal-reshenie-po-vendingovym-apparatam.html
Evgeny Nifantyev proposed measures to prevent the sale of uncertified medical devices on marketplaces
Speaking at a meeting of the Federation Council, Evgeny Nifantyev, Deputy Chairman of the State Duma Committee on Health Protection, drew attention to the problem of products sold through marketplaces that are outwardly indistinguishable from medical devices. He identified these as bandages, posture correctors, blood pressure monitors, thermometers, and nebulizers, which lack the mandatory registration certificate from Roszdravnadzor and the "Honest Sign" marking, and whose cost is significantly lower than that of certified analogs.
The parliamentarian proposed developing legislative measures to protect consumers from uncertified products. He believes these measures should include establishing liability for marketplaces posting misleading product information, introducing mandatory pre-moderation of product listings in relevant and related categories, and creating an interdepartmental mechanism for the prompt removal of such products from online stores. He advised Russians to purchase medical products only from licensed pharmacies and specialized medical supply stores, where they can verify the presence of the Roszdravnadzor registration certificate and product marking code.
Earlier, Maria Migeeva, Deputy Head of the Department for State Control and Registration of Medical Products at Roszdravnadzor, reported that four major marketplaces—Wildberries, Yandex Market, MegaMarket, and Ozon—have integrated with Roszdravnadzor's medical product registry. Sellers are now required to provide the registration certificate when creating product cards, and buyers can directly click the link to the Roszdravnadzor website to verify the authenticity of the data.
Market news
The number of legal importers of medical gloves has doubled
The number of legal importers of medical gloves has more than doubled. Since the labeling was introduced, over 40 million packages of labeled products have already been placed into circulation. The labeling experiment is ongoing, and the labeling features for sterile gloves remain in place and are being further refined.
Thirty-two companies importing medical gloves, which previously operated in the "gray" zone, have entered the legal market. Thus, 61 importers are currently connected to the labeling system, Chestny Znak told FV.
"Instead of disparate and often "gray" schemes, a controlled chain of product movement is being established. This is a significant step in the fight against counterfeiting and consumer protection. Now we know exactly who is importing these medical products into the country and in what quantities," noted Revaz Yusupov, Deputy General Director of CRPT (operator of the Chestny Znak labeling system).
Problems with counterfeit products in the medical glove segment do exist, with shipments of products of unclear origin occurring, Vadim Vinokurov, head of the Commission on Circulation of Medical Devices and member of the Public Council under Roszdravnadzor, confirmed to FV.
"This situation originated during the COVID-19 pandemic. A huge number of products were registered at the time, and counterfeit products were primarily concentrated in gloves of unknown origin," he explained.
According to him, before the pandemic, latex gloves, primarily manufactured in Malaysia, held the largest market share. However, at the height of the pandemic, preferences among both the medical community and the public shifted toward nitrile gloves.
Starting March 1, 2026, medical device labeling regulations will be tightened. Russian Government Resolution No. 1409 of September 1, 2025, amends the regulations to expand the list of transactions subject to tracking. Submission of labeling data for medical gloves and incontinence products will become mandatory not only when introducing and withdrawing products from circulation, but also for any other transactions involving the transfer of ownership. Monitoring will extend to intermediate transactions, including commission agreements, agency agreements, subcontracts, and assignments.
Medical supply cartel uncovered in Sverdlovsk Region
The Sverdlovsk Office of the Federal Antimonopoly Service (FAS) has uncovered cartels in the medical supply market, the antimonopoly agency's press service reported.
It was established that Medialine Group LLC, Promed LLC, and Kardeya LLC entered into price-fixing agreements in a tender for the supply of glucose test strips and transcutaneous glucose monitoring system sensors.
According to the Federal Antimonopoly Service (FAS), the cartel participants deliberately eschewed competition, using a unified strategy and a "third wheel" scheme to restrict the procurement of foreign-made goods. The companies used a single IP address to submit price proposals for procurement procedures. An audit revealed overlapping user accounts, file creation and modification times, as well as the size, content, style, and titles of the documents.
The cartel participants' total revenue amounted to 326.9 million rubles. The companies disagreed with the administration's position and appealed the decision to the Federal Antimonopoly Service (FAS). The Service upheld the decision of the regional office.
The companies received the following fines:
- Medialine Group — 53.5 million rubles;
- Promed — 12.3 million rubles;
- Cardeya — 3 million rubles.
All fines were partially paid during the grace period.
The materials have been submitted to law enforcement agencies to determine whether to initiate criminal proceedings under Article 178 of the Russian Criminal Code (restriction of competition).
Other
The Russian President signed a law on mandatory mentoring for doctors and nurses
Russian President Vladimir Putin signed a law introducing a mandatory three-year mentoring period for graduates of medical colleges and universities (the document is available on MV). The mentoring requirement does not apply to graduates of pharmaceutical educational programs.
The State Duma of the Russian Federation adopted the law on mentoring for graduates of medical colleges and universities in its final reading on November 11. According to the amendments, all medical specialists who have completed higher and secondary vocational education after 2026 will be required to complete a three-year mentoring period in clinics operating under the compulsory medical insurance system. For certain specialties and in some regions, such as the Arctic, this period may be reduced. The specific list will be approved by the Russian Government and the Ministry of Health.
Russian Health Minister Mikhail Murashko stated that "this decision will change the situation with staffing in the healthcare system" and will positively impact the quality and accessibility of medical care in the country. The mandatory three-year mentoring period also applies to fee-paying students.
According to a survey of the online audience of the Medical Herald portal, more than half of respondents said they do not believe the mandatory training system for medical specialists being introduced in Russia is an effective way to address the industry's personnel shortage. One in four of them stated that in a capitalist society, such issues should be addressed through high salaries and good working conditions. At the same time, some commentators noted that mentoring will provide young specialists with practical experience, which will be useful "including for determining their future career path."
Scientists have identified a key difference in the impact of cigarettes and heated tobacco systems on vision
Cigarette smoking directly damages vision. Scientists from Italy, Indonesia, and Saudi Arabia conducted an experiment on human and rabbit corneal cells, comparing the effects of traditional cigarette smoke with aerosols from heated tobacco systems and regular air. A new international study, published in the journal IOVS, reveals the ophthalmic mechanisms of smoking's effects on the cornea, a key structure of the eye.
To study the link between smoking and adverse vision effects, the scientists used rabbit corneas and donor human corneas, from which epithelial cells were isolated. The corneas were exposed to three methods: cigarette smoke, aerosols from heated tobacco systems, and regular air. The study measured levels of reactive oxygen species, the activity of genes responsible for inflammatory processes, and the level of cellular protection from oxidative stress.
Proteomic analysis, spectrometry, and quantitative PCR revealed that cigarette smoke causes the greatest oxidative stress and inflammation, leading to significant epithelial damage. The difference in the rate of regeneration after a scratch also proved critical: the cornea did not recover even after 72 hours of exposure to cigarette smoke, whereas after exposure to air and aerosol from heating systems, cells regenerated within 48 hours.
Furthermore, scientists have found that smoking regular cigarettes can lead to increased intraocular pressure and the development of age-related macular diseases, which lead to retinal damage, an increased risk of nuclear cataracts, and changes in the tear film. These data confirm that smoking cessation is a key factor in reducing the risk of developing vision-related diseases.
For adult smokers who are unable or unwilling to quit nicotine, switching to smokeless products, which eliminate the combustion process, can be part of a risk-modification approach. Its key element is risk-based regulation, which, on the one hand, protects minors from consuming any nicotine-containing products, and on the other, provides adult chronic smokers with the opportunity to consciously switch to a less harmful tobacco product that works by heating rather than burning.
The Russian State Duma announced plans to tighten oversight of nail salons and tattoo parlors
Russia has proposed tightening oversight of invasive non-medical services. This includes manicures, permanent makeup, piercing, and tattooing. The growing popularity of these services requires the development of mandatory state standards to ensure consumer safety. State Duma Deputy Nikolai Shcheglov proposed the initiative on November 17 at a roundtable discussion of key indicators for the federal project "Combating Hepatitis C and Minimizing the Risk of Spreading This Disease," reports an MV correspondent.
"From a professional perspective, tattooing, manicure, and piercing are all mini-surgeries, as they involve damage to the skin and mucous membranes. The number of people who use these services is enormous. We must protect them. We have national standards regarding tattooing and piercing, and they are very clearly laid out. "But currently, the national standardization system documents are applied on a voluntary basis. And if a specialist doesn't adhere to these recommendations, it's on their conscience," the deputy explained.
Access to these services for minors should be restricted. That is, adolescents under 18 should only be provided with parental permission, Alexey Kurinny, a member of the State Duma Committee on Health, supported his colleague. These initiatives will later be formalized as recommendations following a roundtable discussion and sent to the relevant agencies.
The State Duma has begun drafting bills to regulate the activities of tattoo parlors. The drafts are expected to be submitted to parliament for consideration in the fall, Badma Bashankayev, First Deputy Chairman of the Committee on Health, previously reported. He cited examples of minors getting tattoos on their faces and other parts of their bodies without parental permission, only to later regret it.
New registered medical devices
We publish a list of new medical devices registered from 11.14.2025 to 11.21.2025
Link to the list: [see table in the attachment]
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