News Digest 21.11.2025 — 28.11.2025
Regulators
EAEU regulations will expand the permissible cases for the circulation of unregistered medical devices
The Russian government has ratified amendments to the Agreement on the Single Market for Medical Devices in the EAEU, which detail the cases in which medical devices are not subject to registration. Specifically, the regulations will include the import of medical devices for life-saving indications, devices manufactured within the EAEU for subsequent export, as well as medical device kits and sets registered individually in member states. The protocol will be provisionally applied ten days after signing.
The amendments will affect cases in which the circulation of medical devices does not require registration. Three new provisions will be added: the import of unregistered medical devices for life-saving indications based on a permit issued by the authorized body of an EAEU member state, provided that such a procedure is legally provided for in that state; the production of medical devices intended for export, provided that they will not be used in medical practice within the EAEU; A set of medical devices and medicines—kits, kits, and first aid kits, contained in a single consumer package, registered in the territory of a member state and intended for circulation within its territory.
In addition, medical devices manufactured to individual patient orders for personal use only will be exempt from registration. Previously, only such devices manufactured within the EAEU were exempt from registration.
The protocol will enter into force after signature by all EAEU member states. The provisional effect of the regulation will begin 10 days after signature in countries where this procedure is regulated.
Previously, participants in the EAEU single market for medical devices prepared a protocol amending the agreement, extending the transition period, during which market participants can register medical devices under both national and Eurasian regulations if they are circulated in more than one country, until 2028. The countries participating in the EAEU single medical device market justified this decision by "the economic situation requiring the preservation of national rules for registering medical devices."
In Russia, the deadline for submitting applications for registration under national rules (Resolution No. 1684) is expected to be extended until the end of 2027, while re-registration and amendments to the registration dossier will be extended until the end of 2028.
The Russian Ministry of Health has already prepared the relevant amendments, and the Russian Government approved the amendments to the protocol on October 17, 2025.
The Government Expanded Risk Categories for Medical Device Inspections
The Russian Government approved the regulations on federal state oversight of medical device circulation, as amended by the Ministry of Health. Specifically, the amendments include the inclusion of the "high risk" category in the risk categories for causing harm.
According to the resolution, Roszdravnadzor must conduct an inspection visit, on-site inspection, test purchase, or random inspection for high-risk categories once every two years.
Furthermore, preventive visits and other oversight activities will now be conducted not only in the form of a preventive conversation at the place of business or via videoconferencing, but also via the "Inspector" mobile app.
For regulated entities that have submitted notification of the commencement of certain types of business activities (technical testing, toxicological testing, manufacturing, storage, transportation, sale, disposal, and other activities), Roszdravnadzor will be able to conduct a mandatory preventive visit no later than six months from the date of such notification. For high-risk categories, this is done once a year. A special report will be prepared in duplicate after the completion of such a visit.
Furthermore, the updated document eliminates the clause stipulating that a supervised individual has the right to refuse a mandatory preventive visit by notifying the state oversight body no later than three business days prior to the scheduled visit. The initial version of the draft also proposed eliminating the use of audio recording during inspections, but this clause was not included in the final version of the resolution.
The regulation has been supplemented with a clause stating that examinations, interviews, and expert assessments may be conducted using remote interaction tools.
Complaints against the actions (inactions) of Roszdravnadzor will be reviewed by the Ministry of Health. Supervised individuals whose rights and legitimate interests, in their opinion, have been violated during state oversight have the right to a pre-trial appeal. Complaints will be reviewed within 15 business days from the date of their registration. Under the previously applicable document, the complaint review period was set at no more than 20 business days. An appeal against a decision to classify controlled items into the relevant risk category will be reviewed within no more than five business days.
According to the document, classifying a state-controlled item into a high-risk category will be carried out in connection with the production and/or manufacture of medical devices and the conduct of clinical trials of medical devices.
In March 2025, it was reported that Roszdravnadzor had conducted 559 unscheduled inspections in the medical device sector over the previous year. As a result of these inspections, the regulator conducted 3,008 control actions. The total amount of administrative fines imposed amounted to 60 million rubles.
Source: https://vademec.ru/news/2025/09/22/minzdrav-rasshirit-kategorii-riska-pri-proverke-medizdeliy/
The government has clarified the labeling parameters for disposable technical rehabilitation devices
Amendments have been made to Russian Government Resolution No. 744 of May 31, 2024, "On Approval of the Rules for Labeling Certain Types of Technical Rehabilitation Devices with Identification Means and the Specifics of Implementing a State Information System for Monitoring the Circulation of Goods Subject to Mandatory Labeling with Identification Means, Regarding Certain Types of Technical Rehabilitation Devices."
The amendments affect the labeling of urostomy bags, urethral self-catheterization kits, and disposable drainage catheters. Although the general group of urine and ostomy bags was already subject to labeling in 2024, according to the approved amendments, labeling of these products will begin on February 1, 2026. Operators placing technical rehabilitation devices into circulation must affix special labels to the packaging and the products themselves and submit this information to the monitoring information system. For products packaged directly at the factory, the label will be applied to the consumer packaging. Imported products purchased before January 31 and released by customs authorities after February 1, 2026, for domestic sale or re-export, must be labeled by operators by February 28, 2026.
The regulation establishes a transition period: if unmarked TMR exist on February 1, 2026, but were imported or placed into circulation before January 31, their sale without special labels will be possible until February 28, 2027. Until this date, unmarked TMR will be allowed to be traded and withdrawn from circulation in cross-border trade or when placed under customs procedures for release for domestic sale before January 31, 2026.
The regulations specify print quality requirements for identification devices—they must meet quality standards of at least Class 1.5C and the requirements of the Russian national standard GOST R ISO/IEC 15415–2012.
Marking of certain TMRs became mandatory on September 1, 2023. Initially, wheelchairs were subject to marking, followed a month later by orthopedic shoes. Such marking was introduced for hearing aids and absorbent garments on March 1, 2024. In the fall of that year, similar regulations were introduced for other types of TMRs: crutches, supports, support and tactile canes, orthoses and functional prosthetic components, anti-decubitus pillows and mattresses, urine and ostomy bags, and chairs with sanitary fittings.
At the end of November 2024, the Russian Government approved a resolution specifying additional product groups in a document listing cases in which the sale of products subject to mandatory identification marking is prohibited due to the presence or absence of certain information in the Chestny Znak system. Effective October 1, 2025, a ban was introduced on the sale of technical means of production if the system does not contain information about their marking, if the Chestny Znak system indicates a ban or suspension of sale and use of the product by decision of regulators, or if the product's expiration date has expired.
Source: https://vademec.ru/news/2025/11/24/pravitelstvo-utochnilo-parametry-markirovki-odnorazovykh-tsr/
Rosstandart to develop a GOST standard for digital product labeling
Rosstandart plans to begin developing a GOST standard for digital product labeling in June 2026, according to a representative of the federal agency Vedomosti. The work is expected to be completed by December 2026. The document will outline key requirements, terms, and definitions related to digital labeling. The GOST standard is planned to be submitted for supranational discussion with a view to its implementation in the regulatory framework of the EAEU and CIS countries.
It is expected that the GOST standard will provide for the standardization of digital solutions that will help minimize risks in the event of failures, specifically preventing blocking of product shipments and circulation. Experts also believe that the standard will facilitate software standardization, which could help reduce the number of problems arising when integrating cash registers with accounting systems.
Svetlana Voskoboinik, Deputy Executive Director for Legal Affairs at the Russian Association of Pharmacy Chains (RAAC), noted that GOSTs do not meet the criteria for a regulatory legal act—a position the Supreme Court of the Russian Federation has consistently upheld over the past several years. The voluntary nature of compliance with national standardization system documents is also enshrined in Federal Law No. 162-FZ of June 29, 2015, "On Standardization in the Russian Federation." "They become mandatory for the manufacturer when they publicly declare their products' compliance with the GOST and express their desire to label them with the national standard mark," Voskoboinik emphasized.
The RAAC representative added that the developers of the "Chestny Znak" system have already taken on the role of unifying approaches to integrating various software and synchronizing vast amounts of data, and a sufficient number of software operators successfully interact with the system without experiencing any significant difficulties.
In Russia, the Center for the Development of Advanced Technologies (CRPT) is responsible for labeling products through the "Chestny Znak" system. The platform accumulates data on labeled products, including medicines, technical means, veterinary drugs, pharmaceutical raw materials, cosmetics, medical devices, antiseptics, dietary supplements, sports nutrition, and wheelchairs. Several regulators simultaneously monitor compliance with regulations using the data and tools from Chestny Znak. Rospotrebnadzor oversees the labeling of dietary supplements and antiseptics, while the Ministry of Labor of the Russian Federation oversees the identification of wheelchairs.
In mid-November of this year, Revaz Yusupov, Deputy General Director of the CRPT, announced a plan to integrate the national labeling system with the Unified Information System for Procurement. Completion of the work and the transition to the new model are also scheduled for 2026. The CRPT believes that the unification of the platforms will allow for automatic product verification during public procurement and the rejection of expired, counterfeit, or potentially unsafe goods.
Source: https://vademec.ru/news/2025/11/26/rosstandart-razrabotaet-gost-po-tsifrovoy-markirovke-produktsii/
Market news
Siberian State Medical University has gained the ability to produce medical devices with AI
Siberian State Medical University (SSMU) has received accreditation from Roszdravnadzor (the Federal Service for Surveillance in Healthcare) for the production of Class 3 medical devices. This allows the medical school to develop and commercialize medical devices and software powered by artificial intelligence (AI). This work is being carried out under the Priority 2030 program.
The university's flagship project, "New Generation Medical Devices," aims to create a digital ecosystem for "managed health." During the project, SSMU specialists developed a number of systems and platforms for physicians, including the "Ophthalmic+" system, the "Neuro-Kinesis" gamified platform for remote neurorehabilitation, and the "Spiro-Graphics" portable spirometer.
The university noted that the new model offers a personalized approach. Patients become direct active participants in the entire process—the operators and owners of medical data—while physicians are provided with tools for analyzing the information and preventing various diseases.
Ivan Tolmachev, head of the Digital Medicine and Cyberphysics Research and Technology Center at Siberian State Medical University, explained that the project's implementation allows for a "reboot of the very philosophy of healthcare"—patients will be transformed from "passive observers into protagonists, armed with data and technologies for proactively managing their lives."
Sechenov University is also developing AI-powered medical devices and software. In early November, it was announced that the university's specialists had developed a new tool—the digital assistant "InfoMedica AI." The neural network allows for the analysis of various clinical cases and the receipt of a detailed response, supported by relevant medical sources.
Source: https://vademec.ru/news/2025/11/24/sibgmu-poluchil-vozmozhnost-proizvodit-medizdeliya-s-ii/
A packaging manufacturer from the Leningrad Region invested 1.5 billion rubles in medical device production
MiruMed (part of the Mir Upakovki Group) announced the launch of a new medical device production facility in Sertolovo, Leningrad Region. According to company representatives, the investment in the project exceeded 1.5 billion rubles. Production capacity is estimated at 180 million vacuum tubes and at least 400 million plastic components for their subsequent assembly per year, as well as up to 300 million finished sharpened needle tubes for the subsequent production of medical needles for various purposes. The facility is the Group's first project in the healthcare industry.
The products will be manufactured at the MiruMed site using a full production cycle. The company called the launch of a line for the production of finished sharpened needle tubes a significant milestone in its import substitution program. These products are a key component for the subsequent manufacture of a wide range of medical needles, including double-ended, injection, fistula, insulin, butterfly, and catheter needles. The planned products will be manufactured in accordance with GOST requirements and GMP standards.
In recent years, Russian operators have significantly increased their investment in equipping their production facilities for drug packaging, medical consumables, and lightweight medical equipment. For example, in July 2025, Nizhpharm announced the launch of a new line for the filling and packaging of soft dosage forms, with an investment of 158 million rubles. In September 2024, Diakont, a Russian manufacturer of medical devices for patients with diabetes, announced the imminent launch of a 1 billion ruble production facility in Korolev, Moscow Region, for insulin pumps and biosensors for blood glucose monitoring. In October 2023, the Medical Technologies Plant (part of the Zdravmedtech Group) began mass production of double-ended venous blood collection needles with a visualization chamber in Kamensk-Uralsky, Sverdlovsk Region. 130 million rubles were allocated for the project.
Other
Danes Receive Compensation for Vision Loss After Taking Weight-Loss Drugs
The weight-loss and diabetes medications that made Novo Nordisk a global pharmaceutical industry star have been linked to a rare but potentially irreversible vision impairment. Danish authorities have already awarded compensation to the first victims.
The Danish Independent Patient Compensation Authority has awarded compensation to four people who developed optic nerve infarction after using semaglutide-based medications—known under the brand names Ozempic (for type 2 diabetes), Wegovy (for obesity), and Rebelsas (also for diabetes, but in tablet form). Reuters reports.
The decision does not impose legal liability on Novo Nordisk, the pharmaceutical company that produces the medications. Under Danish law, such payments are assumed by the state, although the budget for these purposes is formed, in part, from taxes levied on manufacturers.
In total, the victims will receive 800,000 Danish kroner (approximately $123,000). This amount may increase if they become incapacitated.
In total, the agency received 43 reports of vision problems following semaglutide injections. Four of the five cases reviewed were diagnosed with non-arteritic anterior ischemic optic neuropathy (NAION), a condition in which the blood supply to the optic nerve is disrupted, potentially leading to vision loss. It is noted that assessing each case was challenging, as the patients already had an increased risk of heart attack due to diabetes and obesity.
In June of this year, the European Medicines Agency (EMA) classified NAION as a "very rare" side effect of semaglutide. For every 10,000 people using the medication, there is up to one case of optic nerve infarction per year.
Novo Nordisk reportedly reviewed the Danish regulator's decision and updated the labels of all its products, adding a warning about NAION. The company also emphasized that semaglutide's overall safety profile remains favorable.
New registered medical devices
We publish a list of new medical devices registered from 11.21.2025 to 11.28.2025
Link to the list: [see table in the attachment]
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