News Digest 03.10.2025 — 10.10.2025
Regulators
The ban on the export of pharmaceuticals and medical devices has been extended until the end of 2027
The ban on the export of pharmaceuticals and medical devices from Russia will remain in effect until the end of 2027. The restriction was introduced in 2022, and the government has now signed a document extending it.
The government has extended the restrictions on the export of certain goods from Russia. Resolution No. 1516 of October 2, 2025, was published on the legal information portal.
In March 2022, the government established a list of goods and equipment prohibited from export from Russia. The decision was made in compliance with Presidential Decree No. 100 of March 8, 2022. The list then included medical, technological, and telecommunications equipment, vehicles, agricultural machinery, and electrical equipment imported into the country—a total of more than 200 items.
Subsequently, pursuant to Presidential Decree No. 100, Resolution No. 311 of March 9, 2022, was approved. The document approved a list of goods subject to a temporary export ban. It also included pharmaceuticals and medical devices (EAEU TN VED Code 3006). The export ban was initially in effect until the end of 2022 and was subsequently extended several times. The new resolution extends the ban until December 31, 2027.
The Ministry of Finance clarified the country of origin validation procedure for polymer medical devices
The Russian Ministry of Finance clarified the temporary procedure for confirming the country of origin for polymer medical devices. Previously, the Russian Government extended the possibility of country-of-origin validation for medical devices under the old rules, provided that an agreement is concluded by or before December 31, 2025. The resolution retained two provisions: the requirement to use only the ST-1 certificate or a package of documents including the ST-1, a Chamber of Commerce and Industry opinion on the ad valorem share, and compliance with the quality management system.
According to the Ministry of Finance's clarification in letter No. 24-09-06/96011 dated October 3, 2025, for medical devices made of polymeric materials, including devices for blood and blood substitutes transfusions, containers for the collection, storage, and transportation of donor blood, urine bags, and ostomy bags, the priority requirement remains the one requiring a combination of documents: an ST-1 certificate, an expert opinion from the Chamber of Commerce and Industry of the Russian Federation or a similar document confirming compliance with the ad valorem share, and a document confirming the requirements of ISO 13485-2017 "Medical Devices. Quality Management Systems."
In June 2025, the Ministry of Industry and Trade developed draft amendments to Government Resolution No. 1875, proposing to temporarily remove the requirement for points, subject to the presence of an ST-1 certificate or an entry in the register of domestic products without specifying points. At that time, it was assumed that certificates issued before the introduction of the points system would expire by the end of 2026, and the recognition of products in procurements notified in the Unified Information System for Procurement, or in sole-source contracts for which it was concluded, would remain in effect until December 31, 2026, inclusive.
In August 2025, the government amended Government Resolution No. 1875, which established a transition period for confirming the country of origin of goods until amendments to Eurasian Economic Union law regarding the implementation of the Eurasian Register. Specifically, the ability to confirm localization under the old rules using the ST-1 certificate was extended.
Regulators have been instructed to more strictly monitor customer bids for public procurement of medical devices
The Russian government has approved the National Competition Development Plan for 2026–2030. It states that the Ministry of Health, the Ministry of Finance, and the Federal Antimonopoly Service should encourage customers purchasing medical devices to be more detailed in their bids. Regulators will ensure that the description of the subject matter of the procurement includes technical and functional characteristics of the product in accordance with the catalog of goods, works, and services for meeting state and municipal needs.
The government decree stipulates that the responsible agencies must submit a report to the government by March 2027 on the results of their work. Customers are already required to submit detailed bids for the purchase of medical devices—this measure is prescribed in Federal Law No. 44-FZ "On the Procurement of Goods, Works, and Services by Certain Types of Legal Entities." However, many operators try to circumvent this requirement to further their own interests.
The government is systematically establishing legislative norms to ensure security in public procurement. For example, in June 2025, Russian President Vladimir Putin signed a federal law establishing a state system to prevent, detect, and suppress agreements that restrict competition. This law will enable the Federal Antimonopoly Service (FAS) to scan data on all ongoing tenders, including using artificial intelligence. This new law will affect the supply of medicines and medical devices, which, according to 2024 data, is among the top three industries with the highest number of anticompetitive agreements.
The decision to approve the National Competition Development Plan for 2026–2030 was made because the previous plan expires in 2025. In the approved document, the government also outlined goals for the next five years and summarized the work of the previous period.
The order defines seven development goals: a comfortable and safe living environment, environmental well-being, population preservation, improved health, family support, and others.
Over the past five years, work has been carried out in the healthcare sector to determine the interchangeability of 70.45% of medicinal products for human use, which has enabled Russian consumers to receive sufficient quantities of medications at affordable prices, the document notes.
Roszdravnadzor will simplify the process of updating registration dossiers for AI-enabled medical devices developers
Roszdravnadzor will simplify the process of amending the registration certificate (RC) of artificial intelligence-enabled medical devices (AI-enabled medical devices) for companies that automatically submit monthly device usage data to the regulator. This order is currently undergoing final approval and will soon be adopted, Dmitry Pavlyukov, Deputy Head of Roszdravnadzor, announced at the plenary session of the International Congress "Information Technologies in Medicine," according to an MV correspondent.
"Working with artificial intelligence products, we understand that it is crucial for us to have data on their use, understand the scale of their use, and the number of studies conducted on them, in order to estimate the incidence of adverse events, which economic entities are already required to report," Pavlyukov said. He noted that there is a significant difference between the same adverse event occurring in a product that has been used 1,000 times versus 10 times. Companies that provide the regulator with information on the use of AI-enabled medical devices are expected to be exempt from expert review and additional assessments when making changes to the regulatory documents. This exemption applies to cases where the product does not fundamentally change. If a developer wants to examine brain images instead of chest images, for example, then a clinical assessment is still required, Pavlyukov clarified.
In July, Roszdravnadzor developed a procedure for transferring data on AI-enabled software registered as a medical device. According to the document, entities using such software can submit monthly information on the data processed and the results of actions to the service's information system. After gaining access to their personal account, developers must connect the medical device to the software interface, which will ensure automated data transfer. This includes:
- name of the medical device, number and date of the registration certificate;
- information about the medical device version;
- scope of application (solution type);
- information about the period for which the information is provided;
- information about the number of studies or objects processed using the medical device;
- data on the results of the medical device's operation during the specified period;
- data on the number of errors;
- the medical organization's taxpayer identification number or its unique identifier in the OID (Object Identifier).
The Government Approved the National Competition Development Plan for 2026-2030
Prime Minister Mikhail Mishustin signed Order No. 2816-r dated October 8, 2025, approving the National Competition Development Plan for 2026-2030. According to the new plan, the Federal Antimonopoly Service of Russia, the Ministry of Health of Russia, and the Ministry of Finance of Russia will more strictly monitor customer applications for public procurement of medical devices under Federal Law No. 223-FZ.
"Ensuring incentives for customers making purchases under the Federal Law 'On the Procurement of Goods, Works, and Services by Certain Types of Legal Entities' to include technical and functional characteristics of the product in the description of the procurement item for medical devices, in accordance with the catalog of goods, works, and services for meeting state and municipal needs (if any)," states paragraph 28 of the National Plan.
The responsible ministries are to submit a report to the Government of the Russian Federation by March 1, 2027.
One of the industry-wide measures involves the launch of several new modules of the state information system for the prevention, detection, and suppression of agreements restricting competition (GIS "Anti-Cartel"). This goal has been assigned to the Federal Antimonopoly Service, which is scheduled to submit a corresponding report to the Government of the Russian Federation in January 2029.
Changes to public procurement envisage the completion of the digitalization of procurement appeal procedures for certain types of legal entities. By 2030, it is planned to transition to 100% of such complaints being submitted electronically, which will greatly simplify the ability of applicants to protect their rights. The Federal Antimonopoly Service of Russia, the Ministry of Finance of Russia, and the Treasury of Russia are responsible for these processes.
Regional roadmaps for promoting competition for the next five years must be approved by May 1, 2026.
A similar five-year plan, approved in 2021, expires at the end of this year.
The Ministry of Finance has clarified how to confirm the country of origin of certain goods following the entry into force of amendments to Russian Government Resolution No. 1875 dated December 23, 2024
This concerns the application of Resolution No. 1875 following the amendments introduced by Russian Government Resolution No. 1326 dated August 29, 2025.
The regulator clarified the relationship between subparagraphs "d" and "g" of paragraph 10 of Resolution No. 1875 as they apply to blood and blood substitute transfusion devices, containers for the collection, storage, and transportation of donor blood, urine bags, and ostomy bags (items 400–415 and 429–432 of Appendix No. 2 to Resolution No. 1875).
In its response to the request, the agency stated that the information and documents confirming the origin of the above-mentioned goods from EAEU member states, including the Russian Federation, are the data specified in subparagraph "d" of paragraph 10 of Resolution No. 1875.
Therefore, the provision of subparagraph "d" of paragraph 10 of Resolution No. 1875 is specific to subparagraph "d" of paragraph 10 of the aforementioned act.
This means that the country of origin of goods from the EAEU must be confirmed in conjunction with the ST-1 certificate:
- an expert examination report from the Chamber of Commerce and Industry of the Russian Federation or a similar document issued by an authorized body (organization) of an EAEU member state, indicating the share of the cost of foreign components (raw materials) in the price of the final product;
- details of the document confirming the compliance of the production of medical devices with the requirements of GOST ISO 13485-2017.
As a reminder, subparagraphs Clause 10 of Resolution No. 1875 applies to procurements announced before the end of the current year.
Source: https://t.me/zakupki44fz/11009
Market news
Rostec Launches MRI-Compatible Pacemaker for Arrhythmia Patients
Russia has launched the first MRI-compatible pacemaker, the Apollo MRI. The device allows patients with severe arrhythmia to safely undergo magnetic resonance imaging (MRI) examinations.
Rostec State Corporation has begun serial production of the first Russian pacemaker compatible with magnetic resonance imaging (MRI). The Apollo MRI is intended for implantation in patients with severe arrhythmia, the company's press service reported.
The device provides continuous cardiac monitoring tailored to the patient's individual needs and can store data for subsequent analysis by a physician. The devices are already being implemented in leading Russian healthcare institutions.
By 2027, Rostec plans to produce up to 5,000 such pacemakers annually.
MV previously reported that the US Food and Drug Administration (FDA) approved a vagus nerve stimulator for the treatment of arthritis. The SetPoint Medical device delivers electrical impulses that stimulate the nerve and reduce inflammation.
Helix invested 1.5 billion rubles in a new laboratory complex in Moscow
The Helix International Medical Laboratory will open a high-tech laboratory complex in Moscow in 2026 with a capacity of 300,000 tests per day. Total investment in the project has exceeded 1.5 billion rubles, the company told MV.
The new facility occupies 10,000 square meters in the Neopolis business district in the southwest of Moscow. Production solutions include the implementation of a closed-loop process and robotic movement of containers with biomaterial samples across the facility. This eliminates human error during the pre-analytical and analytical stages and guarantees high speed and accuracy of test results.
In particular, the use of automated tracking lines for next-generation immunoassay analyzers and hematology analyzers will reduce the turnaround time for the most common clinical blood and urine tests, while the overall volume of tests will increase fivefold, Helix's press service told MV. The facility is equipped with modern, high-tech laboratory equipment from leading global and Russian manufacturers: Beckman Coulter (USA), Mindray (China), Roche Diagnostics (Switzerland), and BD Kiestra (USA).
According to Forbes, the company ranks first on the list of the five most profitable medical franchises in Russia for 2025. It outpaced its competitors: LabQuest, Biorise, CleanClinic, and Gemotest. Of the 675 centers located in Russia, more than 40% are franchised. Last year, the number of franchised clinics increased by 94 positions. Experts attributed this rapid growth to the company's low start-up investment: launching a business costs an average of 1.9 million rubles, at least 33% less than other laboratory chains. The average annual revenue/profit per location is 36 million/16.8 million rubles.
Pharmasyntez-Medtech and Sibur Promote Localization of Dialyzer Production
Medical device manufacturer Pharmasyntez-Medtech (part of the Pharmasyntez Group) and modern synthetic materials manufacturer Sibur have signed a cooperation agreement aimed at developing the production and processing of polymers used in dialyzer production.
The agreement provides for joint work on the development and scaling of production technologies for polycarbonate, polyethersulfone, and polysulfone—key polymers used in the production of membrane fibers for dialysis equipment.
The Russian hemodialysis market has historically been entirely dependent on imports from Europe and Japan. Dialyzers are primarily assembled from imported membrane fibers and then sterilized. The volatility of foreign currencies against the ruble, as well as current logistical constraints, have led to a significant increase in the cost of consumables and limited their procurement options.
To reduce import dependence, Pharmasyntez-Medtech plans to launch Russia's first production facility for hemodialysis and peritoneal dialysis consumables and equipment in Kaluga in 2026. In 2024, Pharmasyntez and Sibur signed an agreement to supply the new facility with polypropylene and polyethylene. This year, Sibur launched a special grade of polycarbonate compatible with radiation sterilization for the production of dialyzer housings.
The companies will also explore the possibility of jointly conducting laboratory and pilot testing of polysulfones and polyethersulfones resistant to steam and radiation sterilization, followed by certification and technology scaling.
Other
A weight-loss device has been patented in Russia
Specialists at the National Medical Research Center for Therapy and Preventive Medicine have patented an ear clip for electrical stimulation of the vagus nerve. The device is intended for weight loss in overweight and obese patients, said Oksana Drapkina, director of the National Medical Research Center, according to TASS.
The clip is attached to the moistened left ear for 10 minutes 30 minutes before meals. A tingling sensation without pain indicates the device is working properly.
The patent describes a clip consisting of two connected parts with electrodes that stimulates vagus nerve fibers through the ear. This, according to the authors, reduces food intake and alters eating behavior, promoting weight loss. The developers cite earlier studies in minipigs and rats, in which chronic vagus stimulation reduced body weight and improved glucose homeostasis.
Health Minister Mikhail Murashko believes that obesity is one of the key threats to Russian health and requires a systemic solution. According to him, approximately 25% of the Russian population is obese, and the rise in the incidence among children is particularly alarming: up to a third of children aged 7-11 are obese.
The Minister of Health attributes the problem not only to diet but also to a sedentary lifestyle, decreased physical activity after the pandemic, and the active marketing of unhealthy products. In August 2025, parliamentarians proposed officially recognizing obesity as a socially significant disease and recommended establishing regular medical monitoring for patients diagnosed with this condition.
By the early 2030s, revenues from weight-loss drug manufacturers are expected to exceed $150 billion, according to MV.
Source: https://medvestnik.ru/content/news/V-Rossii-zapatentovali-ustroistvo-dlya-snijeniya-vesa.html
The Russian Ministry of Health has clarified the storage of potassium permanganate in pharmacies
Potassium permanganate can be stored in a metal cabinet or in a separate, locked room, the Russian Ministry of Health explained. Pharmacies previously reported that they were refusing to sell it due to new storage regulations for potassium permanganate, and factories had stopped producing the drug.
The Russian Ministry of Health has clarified the storage of potassium permanganate in pharmacies. Pharmacy associations previously reported on the critical situation in the pharmaceutical market following the adoption of Order No. 260n of the Russian Ministry of Health dated April 29, 2025, "On Approval of Storage Rules for Medicines for Medical Use." According to Victoria Presnyakova, head of the Alliance of Pharmaceutical Associations, the document requires potassium permanganate to be stored in a separate room.
The Department for Regulation of Circulation of Medicines and Medical Devices of the Russian Ministry of Health sent an information letter to the Russian Association of Antimonopoly Service (RAAS), which contains clarifications on the storage of potassium permanganate in pharmacies. "Considering that the handling of potassium permanganate must comply with the control measures established for precursors listed in Table III of List IV of the List, as well as the requirements set forth in Section 31 of the Rules, we believe it should be stored in a metal cabinet or in a separate, locked room," stated the letter, signed by department director Elena Astapenko.
"It is becoming increasingly difficult to reconcile regulations governing pharmaceutical activity with one another, as new regulations change familiar wording and lose clarity," Svetlana Voskoboinik, Deputy Executive Director for Legal Affairs at the Russian Association of Antimonopoly Service (RAAS), explained her appeal to the regulator.
One of the pressing questions pharmacies have raised in connection with the new Rules for Storing Medicines, which will come into effect on September 1, 2025, is the storage conditions for potassium permanganate (potassium permanganate). Clause 26 of the new rules stipulates that medicines subject to quantitative accounting, as listed in Section I of the List of Pharmaceutical Products, approved by Order No. 459n (which replaced Order No. 183n of the Russian Ministry of Health dated April 22, 2014), are stored in isolated areas, subject to compliance.
"Then there are references to other regulations, making it difficult for those implementing mandatory requirements—pharmacists or dispensing technicians—to follow the regulator's line of reasoning. In fact, these references apply to precursors of narcotic drugs and psychotropic substances included in List I of Russian Government Resolution No. 681 of June 30, 1998. Potassium permanganate at a concentration of 45 percent or greater remains included in Table III of List IV of that Resolution," says Svetlana Voskoboinik.
However, since potassium permanganate has been included in Section I of the List of Potassium Permanganate Storage Products since 2007, paragraph 26 of the new Storage Rules should have been worded differently, excluding the item "potassium permanganate 45 percent or more," the expert notes.
The repealed Order No. 706n on drug storage, in effect since 2010, established requirements for storing explosive medications in metal cabinets, and potassium permanganate storage products (except narcotic, psychotropic, potent, and toxic) in metal or wooden cabinets, sealed or resealed at the end of the working day.
"The regulator's detailed clarification has restored the status quo. Pharmacies that do not carry narcotic and psychotropic substances do not need to acquire isolated storage areas for small quantities of potassium permanganate; they can use metal cabinets," Svetlana Voskboinik concluded.
Experts point to changes in ophthalmological disease profile
For World Sight Day, celebrated on October 9 this year, Sentiss, a leading ophthalmological drug manufacturer, highlighted the growing strain on vision in the context of widespread digitalization. According to experts, the widespread use of gadgets has led to a shift in ophthalmological disease profile: pathologies are being diagnosed increasingly frequently and at an earlier age, creating a strong demand for modern therapy.
In Russia, the incidence of traditional diseases remains high: cataracts, glaucoma, and age-related macular degeneration, for which timely diagnosis and access to a full range of medications are critical. At the same time, digitalization is fueling the rise of new pathologies: decreased visual acuity, dry eye syndrome, and accommodation spasm—all of which are becoming widespread problems starting in childhood.
"Digitalization has permeated all spheres of life, and we are seeing a consistent increase in visual strain, even in children," noted Elena Platonova, CEO of Sentiss. "Ensuring a stable supply of modern ophthalmic medications that meet international quality standards is a key challenge for the industry." World Sight Day is an opportunity to remind people of the importance of a comprehensive approach to vision preservation. Regular examinations, proper eye hygiene, and a stable supply of modern medications will help effectively address both traditional and new ophthalmological challenges.
First autonomous AI physiotherapist registered in the EU
The Flok Health AI-powered physiotherapy clinic's technology has received certification as a Class IIa medical device under the EU Medical Devices Regulation. According to the company, this is the first time in the UK or Europe that an AI system has been approved for fully autonomous operation—from initial assessment and diagnosis to treatment and discharge—without the need for physician oversight.
The platform has been piloted in the National Health Services in England and Scotland. Flok Health's development provides patients with automated video consultations with an AI-powered physiotherapist via a mobile app.
In addition to expanding the functionality of Flok's existing back pain treatment service, Class IIa approval paves the way for the technology to expand to a wider range of mainstream outpatient care areas after receiving further regulatory approvals, including treatment of hip, knee, shoulder, and pelvic conditions.
As Flok Health CEO and co-founder Finn Stevenson noted, the growing healthcare needs of the population are already outstripping the capacity of the traditional clinical workforce, and only autonomous treatment is a viable solution at scale.
Source: https://t.me/vademecum_live/19502
New registered medical devices
We publish a list of new medical devices registered from 10.03.2025 to 10.10.2025
Link to the list: [see table in the attachment]
News
