News Digest 23.10.2026 — 06.11.2026
Regulators
Roszdravnadzor Suspends Registration of Medical Devices on a Large Scale
In October 2026, Roszdravnadzor (the Federal Service for Surveillance in Healthcare) began suspending the registration of medical devices on a large scale. The reason: companies failed to submit reports on post-registration clinical monitoring (PCM). This concerns Class 3 risk devices and Class 2b implantable devices. According to an industry review, the agency’s letters dated October 13 alone affected 47 different products.
The requirement to conduct clinical monitoring and submit reports was established by Order No. 1113n of the Russian Ministry of Health, dated October 19, 2020, which came into effect in 2021. As of September 1, 2026, Order No. 1113n has been superseded by the Russian Ministry of Health’s Order No. 541n, dated May 26, 2026. The primary change is that reports must now be submitted exclusively through Roszdravnadzor’s automated information system. Notably, the authority to suspend registration due to a failure to submit such reports existed even prior to the transition to an electronic submission process.
"When preparing PCM reports for manufacturers and their authorized representatives, I frequently encounter two main challenges. The first is a dependency on clinical facilities. While the manufacturer or authorized representative is responsible for organizing the monitoring, this obligation does not grant them access to clinical data, nor does it guarantee that a clinic will automatically agree to participate in their program," explains Alina Mustafina, a specialist in the post-registration clinical monitoring of medical devices.
Parties must reach an agreement on what data to collect, which physicians will be responsible for the process, and how the information will be transmitted. Furthermore, in cases involving long-term observation, there is the additional challenge of obtaining long-term follow-up results.
The second issue is a lack of practical experience. "Even when a company knows that a report must be submitted, employees do not always understand how to organize the monitoring process: which metrics to select, which forms to prepare for medical professionals, how to verify the completeness of the data, and who will be responsible for overseeing its submission," says Alina Mustafina.
"Although this requirement has been in effect since 2021, some companies still lack an established data collection process. Therefore, the issue must be addressed systematically—by training staff and clearly defining responsibilities within the organization," Mustafina adds.
FAS and Roszdravnadzor Clarify Specific Issues Regarding Public Procurement of Medical Device Maintenance Services
In a joint letter, the Federal Antimonopoly Service (FAS) and the Federal Service for Surveillance in Healthcare (Roszdravnadzor) have clarified the specifics of public procurement for the maintenance and repair of medical devices. The agencies stated that it is impermissible to mandate the use of exclusively original components if the safety of alternative (generic/compatible) parts has been verified in accordance with established procedures. Furthermore, the regulators deemed it unlawful to require that a service provider possess authorization from the manufacturer to use the software necessary for maintaining the equipment. These clarifications are intended to foster greater competition in the service market and reduce the risk of medical device shortages.
According to the letter dated November 3, 2026, a requirement that consumables, components, and spare parts be "original" does not pertain to the functional, technical, or quality characteristics of the items being procured. Federal Law No. 44-FZ prohibits the inclusion of requirements in a procurement description that would restrict the number of potential participants.
The relevant authorities have pointed out that Russian Government Decree No. 552 of April 1, 2022, permits the maintenance of medical devices using components and accessories not specified in the manufacturer’s documentation. For this to be permissible, the safety of using such items in conjunction with the equipment must be verified through technical testing—and, where applicable, toxicological studies—conducted by the All-Russian Research and Testing Institute for Medical Technology (VNIIIMT) under Roszdravnadzor (the Federal Service for Surveillance in Healthcare), as well as through clinical trials.
Information regarding components and accessories that have successfully undergone the required testing and studies is made available in a public list on the VNIIIMT website, which is updated as new tests are completed. The regulators clarified that this provision applies to all medical devices—not just those currently in short supply or at risk of becoming unavailable. Furthermore, suppliers are not required to obtain authorization from the original manufacturer to use such consumables, components, or spare parts.
VNIIIMT has prepared methodological guidelines for clinical monitoring reports on medical devices
A commission of the Scientific Expert Council—established under the All-Russian Scientific Research and Testing Institute of Medical Technology (VNIIIMT) and the National Institute of Quality of Roszdravnadzor (RZN)—has adopted methodological guidelines for manufacturers and their authorized representatives regarding the procedure and format for submitting post-registration clinical monitoring reports for medical devices. These guidelines apply to medical devices with a Class 3 potential risk level and implantable devices classified as Class 2b.
The document does not constitute a regulatory legal act; rather, it provides clarifications on practical aspects of legislative compliance. Deviating from its provisions will not result in administrative or other forms of liability. The guidelines were developed in accordance with Orders No. 540n and No. 541n issued by the Russian Ministry of Health on May 26, 2026 (which entered into force in September of the same year), replacing similar documents from 2020.
Under Order No. 541n, a manufacturer or its authorized representative is required to conduct clinical monitoring of medical devices and, starting the year after registration, submit annual reports to Roszdravnadzor in electronic format for a period of three years. These reports must be submitted no later than February 1. This monitoring process does not entail new clinical trials; instead, it is based on clinical data gathered through the use of the device in clinical practice within Russia. VNIIIMT evaluates the reports over a period of 120 working days, with the final decision rendered by Roszdravnadzor. If a report is not submitted by the deadline, the device’s registration may be suspended for 30 working days, during which time the document may still be filed.
It is recommended that the report include a list of residual risks, information on adverse events and corrective actions, the objectives and framework for monitoring, clinical data (with identification of the medical institutions involved), an evaluation of this data, and a conclusion regarding the safety and efficacy of the medical device. The developers note that the report cannot consist solely of an analysis of adverse events and complaints, as it must also assess both negative and positive experiences with the device’s use. Feedback from medical institutions that lacks accompanying clinical data is not accepted as evidence of safety and efficacy, and data originating from abroad are considered only as supplementary information. Reports are categorized as initial, follow-up, or final; the final report must include data covering a three-year period, along with a comprehensive analysis thereof.
The appendices to the recommendations outline the primary criteria for evaluating the report—for instance, whether the data were collected in Russia during the post-registration phase within the reporting period; whether the study population, specific batches, and device variants are identified; and whether there is supporting documentation from the medical institutions. The appendices also detail the criteria for extending the monitoring period for an additional three years; such an extension may be required if the available data are insufficient, fail to confirm the device’s safety and efficacy, or if necessary corrective actions have not been implemented.
Another section addresses monitoring following amendments to the registration dossier—a requirement that applies, for example, when expanding the product range or indications for use, altering the patient population or implantation method, or adding a new software module incorporating artificial intelligence.
Market news
Golikova: New Medical Device for PTSD Therapy to Reach Market in 2028
Russian Deputy Prime Minister Tatyana Golikova chaired a meeting of the project committee for the "New Health-Preserving Technologies" national project, where participants reviewed progress made in 2026. During this period, the I. P. Pavlov Institute of Physiology developed and tested an experimental medical device, "i-Pavlovian Cognitive," designed to improve the rehabilitation of patients suffering from depression and PTSD. According to Golikova, the device is scheduled for registration and market launch in 2028.
Furthermore, the Deputy Prime Minister noted that the Yu. M. Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine has developed a therapeutic product for patients with severe joint damage, known as "Chondrosphere." This innovation enables the creation of a "living implant"—identical to healthy human cartilage—using the patient’s own cells (chondrocytes) and blood serum, without the need for donor materials or components of animal origin. Its clinical use is expected to begin in 2028.
Other achievements include the completion of preclinical trials for "CaTeVac," a dendritic cell-based cancer vaccine developed by the N. N. Petrov National Medical Research Center of Oncology; the commencement of registration documentation for a mobile electroencephalograph with biofeedback—designed by the Federal Center for Brain and Neurotechnologies to address cognitive and stress-related disorders in patients with central nervous system conditions; and the development of a drug formulation utilizing the properties of doxorubicin to enhance the delivery of the active agent to malignant tumor sites while reducing cardiotoxicity, created by the V. N. Orekhovich Research Institute of Biomedical Chemistry. Orekhovich.
Tatyana Golikova also noted that in 2026, domestic pharmaceutical companies registered 15 international nonproprietary names (INNs) from the Essential and Vital Medicines List (EVML) that had not previously been produced within the country. The total number of such items registered since the launch of the national project has reached 40. Furthermore, there are currently 10 projects underway for the development of medicinal products and 17 projects for the creation of medical devices.
Other
FDA Approves World’s First Plasmid DNA Immunotherapy for RRP, Used in Combination with a Medical Device
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the world’s first plasmid DNA immunotherapy for recurrent respiratory papillomatosis (RRP): Voceryq (doruxapapogene ralaplasmid / lalikinogene sifuplasmid-gxfd), developed by the American biotechnology company Inovio Pharmaceuticals. RRP is a rare disease caused by the human papillomavirus (HPV). The treatment is administered exclusively via a specialized device called CELLECTRA 5PSP. The FDA also granted the therapy "breakthrough therapy" and "orphan drug" designations.
Voceryq is a recombinant plasmid DNA-based immunotherapy that delivers two plasmids—small DNA fragments originally derived from bacteria—into the body’s cells. One plasmid contains genetic instructions for specific HPV proteins, while the other encodes a molecule called IL-12, which enhances the immune response. The therapy is designed to stimulate the immune system to target and attack cells infected with the specific HPV types (types 6 and 11) that cause recurrent respiratory papillomatosis.
A unique feature of this treatment is that it must be administered using the CELLECTRA 5PSP medical device, developed by Inovio Pharmaceuticals in partnership with the engineering firm NOVO Engineering. This compact, handheld device uses five needles to deliver the medication intramuscularly while simultaneously applying short electrical pulses to the body. These facilitate the temporary formation of pores in cell membranes, through which Voceryq enters the body’s cells directly. This method is known as electroporation.
The safety and efficacy of the product were evaluated prior to approval in an open-label, multicenter clinical trial involving 32 adult patients with recurrent respiratory papillomatosis. In the 12 months leading up to treatment with Voceryq, the participants had undergone two or more surgical procedures to remove papillomas from their larynx and trachea. The clinical trial results showed that 27% of the patients did not require any further surgical intervention during the first year following treatment.
Furthermore, Voceryq is the first plasmid DNA-based immunotherapy to be approved in the United States. The product is also currently awaiting approval in European Union member states.
Obesity is more dangerous than nuclear war: The Lancet assesses global health threats through 2100
Obesity could result in the loss of 23.1 billion years of healthy life—a figure representing potential losses that could be prevented by 2100. This is the highest estimate among the 17 global threats examined by an international commission for *The Lancet*. For a nuclear conflict, the corresponding figure is 9.35 billion years, though this estimate is subject to a high degree of uncertainty.
Low levels of education rank second, accounting for 16.1 billion years of healthy life lost, while income inequality ranks third, with an estimated 13.8 billion years. The authors estimate that the malicious use of AI could lead to a loss of 10.4 billion years, and mental health issues to a loss of 9.35 billion years—the same figure as that for a nuclear conflict.
To compare these threats, the researchers used the DALY (disability-adjusted life year) metric, which accounts for both premature death and time lived with impaired health. The authors evaluated not only the potential burden of each threat but also the extent of the losses that could potentially be averted through risk-reduction measures.
Thus, the 23.1 billion years associated with obesity is neither a forecast of inevitable loss nor an assessment of the impact of a specific prevention program; rather, it is a model-based estimate of the damage that could potentially be prevented on a global scale. For obesity, the uncertainty range is 19.5–26.9 billion years of healthy life, whereas for a nuclear conflict, the range spans from zero to 24.5 billion years.
This discrepancy is partly due to data availability: for chronic diseases, researchers can rely on historical observations, whereas assessing the risks of a nuclear conflict or the malicious use of AI depends heavily on expert judgment and scenario modeling. The authors note that global threats can exacerbate one another, and their consequences depend not only on medical factors but also on socioeconomic conditions. Among the strategies for mitigation, they highlight strengthening healthcare systems, fostering innovation, and improving risk monitoring.
The fact that obesity tops the ranking does not mean it is more dangerous than a nuclear war in terms of the scale of immediate impact or the probability of a catastrophe; rather, the findings indicate that, according to the model used, reducing the risk of obesity offers the greatest potential for preventing the loss of healthy life years among the threats examined.
New registered medical devices
We publish a list of new medical devices registered from 10.23.2026 to 11.06.2026
Link to the list: [see table in the attachment]
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