News Digest 26.09.2025 — 03.10.2025
Regulators
The sale of medical devices through vending machines may be illegal
Roszdravnadzor (Federal Service for Surveillance in Healthcare) sent a letter to regional authorities prohibiting the sale of medical devices and medications through vending machines. All participants in the marketplace must be notified of this, and if violations occur, regional authorities will be required to conduct an inspection. More than a thousand contact lens vending machines operate in Russia, and over 500,000 packages were sold through them last year. These were installed legally: prior to 2021, the Rules for the Sale of Certain Types of Goods contained more lenient language.
Current legislation regarding the circulation of medical devices and medications does not provide for the sale of medical devices and medications through vending machines, Roszdravnadzor reported.
"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 medicines and medical devices is prohibited when retailing at the consumer's location outside of retail outlets by directly familiarizing the consumer with the product (at home, at work or school, on public transport, on the street, and elsewhere)," states the service's letter to territorial authorities.
The clarifications are due to "numerous inquiries from legal entities and individual entrepreneurs regarding the sale of medical devices and medicines through vending machines," the letter states.
The vending machines offer three categories of medical devices: medical masks, contact lenses, and contraceptives. The first lensomats appeared in 2011. They were installed in supermarkets, transportation infrastructure, gas stations, shopping centers, business centers, and pharmacies. As of September 2025, over a thousand contact lens vending machines were operating in Russia. Last year, they sold over 500,000 packages of contact lenses and solutions for cleaning and storing them, the Union of Vending Machine Operators (SOTA) told FV.
"We are currently analyzing the information contained in the Roszdravnadzor letter regarding the sale of medical devices through vending machines," noted Ivan Popov, Chairman of the Union's Board.
Since the circulation of medical devices is not a licensed activity, there is some variability in their distribution on the market, noted Svetlana Voskoboinik, Deputy Executive Director for Legal Affairs at the Russian Association of Anti-Corruption Units (RAAS).
"The legal sale of drugs and medical devices through vending machines is possible if the relevant amendments are made to current legislation," she asserted.
The Ministry of Industry and Trade has proposed amending the list of goods eligible for parallel imports
The Ministry of Industry and Trade intends to revise the list of goods eligible for parallel imports. The draft order is open for public comment until October 10.
The document includes a list of goods, indicating their codes from the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union, means of individualization, and state registration numbers in the State Register of Trademarks.
As stated in the explanatory note to the draft, the parallel import regime currently applies to goods marked with trademarks. However, customs authorities do not have the authority to release goods marked with trademarks without letter designations under the parallel import regime.
Thus, they intend to exclude CAR-T therapy products manufactured by Miltenyi Biotec from the register, as well as the indication that certain general items do not apply to medical devices. The list includes toothpastes (Splat, Korega, Biomed, etc.), as well as Nizoral shampoo and Coloplast shaving products.
In early May 2022, the Ministry of Industry and Trade approved a list of goods subject to parallel import. While drugs were not included, other pharmaceutical products were added to the list: feminine hygiene products from the O.V. and Carefree brands, as well as sanitary bags and first aid kits. In early August, the ministry added reagents and consumables for cancer treatment equipment from Miltenyi Biotec to the list.
Market news
BSS Pharmaceutical Holding Acquires Two Medical Device Distributors
BSS Pharmaceutical Holding, through its subsidiary Edifarm, has acquired a 100% stake in Medimpuls LLC and a 25% stake in Simplant LLC (the remaining 75% of this legal entity is owned by BSS beneficiary Eduard Zakhrabek). The parties have not disclosed the transaction amounts.
The holding explained that the acquired companies are planned to be used to commercialize products from the Endoart plant (part of BSS). The plant has been engaged in the serial production of hip replacements since September 2024. The total investment in this project during the first stage amounted to over 1 billion rubles, financed by the company's own funds. Currently, the first production line has a capacity of 35,000 hip replacements per year.
BSS reported that the plant plans to expand its product line in 2026 by adding revision systems for hip replacements, new models of bioactive-coated endoprosthesis stems, and the first domestically produced knee replacement.
Medimpuls and Simplant will handle logistics, maintenance, and repair of medical equipment. For example, Simplant specialists will focus on repairing power orthopedic equipment and equipping it with Russian-made blades, ensuring the smooth operation of operating rooms. BSS Holding stated that Medimpuls will help expand the product line with endoprostheses manufactured by Endoart. Participation in the development of the holding's product strategy is also among its objectives.
According to SPARK-Interfax, BSS LLC is 100% owned by Eduard Zakhrabekov. In 2024, the holding company's revenue was 68.8 billion rubles, with a net profit of 2 billion rubles.
Over the past few years, BSS has been actively expanding its various business lines. In 2020, for example, BSS-Cosmetics (distributing products for aesthetic medicine and cosmetology) and BSS-Estetika (supplying implants and post-operative garments) were established. Furthermore, the holding company announced the creation of BSS-Lab, which supplies reagents for laboratory research in the fields of immunochemistry, biochemistry, hematology, hemostasis, urinalysis, and supplies for microbiology laboratories.
In 2021, Eduard Zakhrabekov became a 60% owner of BSS Food LLC, announcing his intention to expand into the supply of baby and therapeutic nutrition, including specialized nutrition for young children and those with specific pathologies.
Aesthetic medical product production facility will be launched in Dmitrov for 285 million rubles
A project by Gloreka-Pharma has been added to the Moscow Region's register of regional investment projects (RIP). It will be implemented in Dmitrov for 284.5 million rubles. The facility plans to manufacture medical products for use in aesthetic and clinical medicine.
Deputy Prime Minister and Minister of Investment, Industry, and Science of the Moscow Region Ekaterina Zinovieva announced that the launch of the facility is scheduled for the third quarter of 2026. More than 80 jobs will be created at the facility. The company plans to produce 521,600 units per year.
The investment project is being implemented on a one-hectare plot of land owned by the company. Zinovieva noted that listing the project in the regional individual entrepreneurs' register will allow the company to reduce its profit tax rate from 25% to 10%, with production completely exempt from property tax for the first four years after the facility's commissioning.
According to SPARK-Interfax, Gloreka-Pharma LLC was registered in January 2025 in the Moscow Region. Its primary activity is the production of pharmaceuticals and materials used in medical and veterinary medicine. The company is 60% owned by KST LLC, and 40% by Toscani Laboratories LLC. Mikhail Selyanin holds shares in each company.
In late September 2025, the St. Petersburg-based company MedTechPlus announced the creation of a plant in the Dubna Special Economic Zone in the Moscow Region to manufacture medical devices for respiratory medicine and artificial lung ventilation, as well as consumables for medical equipment.
The facility is scheduled to open in 2027. The investor estimates the investment at 300 million rubles. The production area will be 3,000 square meters.
Other
The UK's National Health Service will launch its first online hospital
In two years, the UK will launch NHS Online, an "online hospital" that will allow patients to receive consultations and referrals for diagnostic tests via an app without visiting a hospital. The service will facilitate access to care and help reduce waiting lists, but experts warn of the need to address digital inequality and staffing issues.
From 2027, patients in the UK will be able to receive medical care through a new National Health Service (NHS) Online service - the so-called online hospital, announced Prime Minister Keir Starmer. The launch of the service will be a key step in the NHS transformation program and is aimed, among other things, at reducing waiting lists for specialist appointments, according to The Guardian.
Patients referred to hospital by a GP will be able to speak to a specialist by phone or video call instead of an in-person appointment, book tests and examinations through an app at nearby diagnostic centers, and track appointments through the NHS app. The service will help clinical teams more quickly determine the urgency of a condition and promptly refer patients for treatment or further examinations.
The approach has already been successfully tested at Southampton University Hospital, where remote consultations reduced the number of in-person appointments by 73% and waiting times by 58%. The new service can include ophthalmology, gynaecology, and gastrointestinal conditions. Starmer emphasized that these are conditions that can be safely treated remotely.
The government believes that digital interaction with doctors via the NHS app will speed up patient routing, improve convenience, and provide greater control over appointments. The NHS app is already used by over 12 million people monthly, with a total of 38.5 million downloads.
Russian scientists have created a "dental sticker" to protect against cavities
Scientists from the National University of Science and Technology MISIS have created a biodegradable gelatin plate with a mineral component that helps not only prevent but also treat cavities in the early stages. NUST MISIS reported this to Gazeta.Ru.
"Traditional dental anti-caries medications are often ineffective: they only temporarily contact enamel, poorly repair microcracks, lack antibacterial components, and have limited therapeutic effect," Kirill Kucheryaev, a co-author of the study and a graduate student at NUST MISIS, told Gazeta.Ru.
The researchers proposed a solution: a biodegradable gelatin-based membrane containing a mineral component, hydroxyapatite, which strengthens enamel. The formula also includes a complex of enzymes to break down plaque.
According to the scientists, the material will be produced in the form of thin plates that are easily attached to the teeth. Patients will be able to apply them themselves: the membrane will adhere to the enamel surface and gradually dissolve, providing a controlled release of active ingredients. This technology increases the contact time with the teeth and prolongs the therapeutic effect.
The researchers noted that the new development could also open the possibility of large-scale production using a simple and inexpensive technology.
Source: https://science.mail.ru/news/8522-rossijskie-uchenyie-sozdali-zubnuyu-naklejku-dlya-zaschityi/
New registered medical devices
We publish a list of new medical devices registered from 09.26.2025 to 10.03.2025
Link to the list: [see table in the attachment]
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