News Digest 12.12.2025 — 19.12.2025
Regulators
Russia Extends Special Regime for Importing Medicines and Medical Devices Until the End of 2027
Russian President Vladimir Putin has extended the import of foreign medicines into Russia until 2027 due to sanctions and shortages. This provision allows for the provision of medications to patients in the event of shortages due to Western sanctions.
The special regime for importing defective medications in foreign packaging into Russia will remain in effect until the end of 2027. The amendments were made to Article 47 of Federal Law No. 61-FZ of April 12, 2010, "On the Circulation of Medicines" (the document is available on MV), which applies to medications intended for circulation in foreign countries. This provision allows for the import of medications into the country in the event of a shortage or the risk of a shortage due to Western sanctions.
Medicines are permitted to enter the Russian Federation if the secondary (consumer) packaging contains a self-adhesive label with information about the drug in Russian. The Russian Ministry of Health drafted amendments to the law in October.
Earlier, Roszdravnadzor reported an 18% increase in the number of citizen complaints regarding the availability of medicines and medical devices this year. In the first nine months of 2025, compared to the same period last year, the number of such complaints increased from 30,400 to 35,900, accounting for a quarter of all complaints about medical care received in the country, MV reported.
Residents of the Tyva Republic and Tomsk Oblast are the least satisfied with their medical care, according to Russian Human Rights Commissioner Tatyana Moskalkova. She cited a shortage of healthcare workers as the main reason, a situation exacerbated by Western sanctions, reduced drug supplies, and procurement delays.
According to Tatyana Moskalkova, there is a lack of oversight in determining drug needs and preparing procurement requests. This applies specifically to the Bryansk, Vologda, Saratov, Amur, and Irkutsk regions, as well as Kamchatka Krai and Bashkortostan.
Roszdravnadzor has developed regulations for the state registration of medical devices
Roszdravnadzor has submitted for public comment a draft order approving administrative regulations for the provision of the state service "State Registration of Medical Devices." The document outlines the procedure and standards for this service, the maximum timeframe for service provision, the grounds for refusing state registration, as well as the composition, sequence, and timeframe of administrative procedures. Specifically, state registration of domestic medical devices must not exceed 10 business days from the date of application.
As stated in the explanatory note, the draft order was developed in accordance with the Rules for State Registration of Medical Devices, approved by the Government of the Russian Federation in November 2024.
The applicant, the draft states, may submit data for inclusion in the list of medical organizations conducting clinical trials (CTs). For this category, the maximum timeframe for providing the service cannot exceed 20 business days from the date of receipt of the CT application.
Roszdravnadzor will also review applications for state registration of medical devices whose efficacy confirmation does or does not require clinical trials involving human subjects. In these cases, the deadline will not exceed 50 business days.
If an applicant requests amendments to documents contained in the registration dossier that do not require an expert assessment of the quality, efficacy, and safety of the medical device, it is proposed to set a deadline of 10 business days for provision of the service. If an expert assessment is required, the deadline is 36 business days.
For amendments to documents contained in the registration dossier for software using artificial intelligence technologies, the deadline may be set at 10 business days. Cancellation of state registration of medical devices must be completed within seven business days.
According to the draft, a state fee will be paid for the service in the manner and amount established by Russian legislation on taxes and fees. The state fee for conducting an expert assessment of the quality, efficacy, and safety of medical devices (depending on the potential risk class of their use in accordance with the nomenclature classification of medical devices) will be increased.
A number of information systems have been proposed for providing this service: the Unified Portal of State and Municipal Services, the federal system "Unified Identification and Authentication System in the Infrastructure Providing Information Technology Interaction of Information Systems Used to Provide State and Municipal Services Electronically," and the System of Interdepartmental Electronic Interaction (SIEI). The service cannot be provided at MFCs.
Roszdravnadzor has also developed a list of grounds for suspending the service, including notification of the need to correct identified violations and/or submit missing documents, a request for materials and information, and a decision to issue permission to conduct clinical trials of the medical device.
The regulator proposes denying state registration if the applicant fails to provide relevant documents and information confirming the acceptability of the risks associated with technical, toxicological, and clinical trials, if identified violations are not corrected, and/or if documents and information are not provided upon request.
As specified in the draft document, a number of administrative procedures must be completed during the provision of the service: applicant profiling, acceptance of the request and documents, interdepartmental information exchange, decision-making on granting (or refusing to grant) the service, and provision of the result. Additionally, the list includes "suspension of service provision," "cancellation of state registration," and "obtaining additional information from the applicant."
The rules for registration of medical devices, approved by the Government of the Russian Federation, entered into force on March 1, 2025. For example, a one-step registration procedure for domestically produced medical devices was introduced, subject to technical and toxicological testing at the All-Russian Research and Testing Institute of Medical Equipment of Roszdravnadzor (VNIIIMT), and clinical trials at federal medical centers (NMICs) accredited by the Ministry of Health.
Furthermore, the new rules establish conditions for including multiple models (brands) of a medical device in a single registration certificate, as well as requirements similar to those in the Eurasian rules for the registration of a new medical device.
Source: https://vademec.ru/news/2025/12/17/roszdravnadzor-razrabotal-reglament-gosregistratsii-medizdeliy/
The Russian Ministry of Industry and Trade has proposed changing the rules for labeling medical devices, effective June 1
Starting June 1, 2026, mandatory labeling of therapeutic respiratory equipment, neonatal incubators, condoms, syringes, infusion sets, wipes, test tubes, plastic surgery and cosmetology implants such as fillers and cosmetology threads, and medical masks may begin. Participants in the circulation of these products will be required to apply identification marks to consumer packaging, the Russian Ministry of Industry and Trade has proposed. The amendments are planned to be incorporated into Russian Government Resolution No. 894 of May 31, 2023.
Furthermore, codes from the All-Russian Classifier of Products by Type of Economic Activity (OKPD) are planned to be added for a number of medical devices already labeled by manufacturers. These include air purifiers, coronary stents, CT scanners, and sanitary and hygienic products used for incontinence.
Inventory purchased before May 31, 2026, and released by customs after June 1, 2026, must be marked before sale and data must be submitted by June 30, 2026. Inventory not sold as of June 1, 2026, may be sold without marking until the expiration date (except for products with a shelf life) or marked and data submitted by May 31, 2027. For products with a shelf life, the expiration date is November 30, 2026.
The manufacturer must submit the following information to the information monitoring system: the reason for registration at the place of business (not specified for individual entrepreneurs) and the global unique identifier of the addressable object in the federal information address system.
Registration may be denied in several cases, including the absence of notification of certain types of business activities, or inconsistencies between the information contained in the application and the information on the types of activities and type of participant in the goods circulation in the notification.
In September, the Russian Ministry of Industry and Trade proposed extending the medical device labeling pilot. The pilot began on September 1, 2024, and was extended in August 2025 at the initiative of the Public Council under Roszdravnadzor, MV reported. Previously, the ministry planned to automatically transfer data on medical devices supplied under government contracts to the Honest Sign product monitoring system starting September 1, 2026.
Roszdravnadzor Completes Integration with Marketplaces for Medical Device Verification
Roszdravnadzor has completed the integration of the information systems of Russia's largest marketplaces—MegaMarket, Wildberies, Ozon, and Yandex Market—with Roszdravnadzor's State Register of Medical Devices.
"This cooperation will enable the verification of a wide range of medical devices sold on online platforms," the agency's press service reported.
Now, marketplaces will be able to make decisions about listing a medical device's product card at the moderation stage (before its publication), taking into account the verification of state registration information. This measure is intended to create a transparent and secure system for online medical device sales.
According to Roszdravnadzor, thanks to cooperation with marketplaces, approximately 500,000 product cards with unconfirmed state registration for medical devices were blocked in 2025.
Roszdravnadzor has extended the issuance of permits for the export of medical devices from the country
Roszdravnadzor has extended the special procedure for the export of certain types of medical products by two years. Order No. 5575 dated October 27, 2025, was published on the legal information portal.
The expiration of the permit procedure for the export of medical products from Russia has been postponed from December 31, 2025, to December 31, 2027.
This concerns the procedure for issuing permits for the export of certain types of medical products included in a special list according to Russian Government Resolution No. 312 of March 9, 2022, "On the temporary introduction of a permit-based procedure for the export of certain types of goods outside the territory of the Russian Federation."
In 2024, the Russian Ministry of Industry and Trade approved the procedure for issuing permits for the export of certain types of industrial products to EAEU countries according to the list in Appendix No. 3 to Russian Government Resolution No. 312 of March 9, 2022.
Market news
Rostec companies will provide turnkey equipment for medical facilities
Rostec subsidiary Tyazhpromexport, a foreign trade association that includes RT-SotsStroy and Medpharmservis.S LLC, has established a medical engineering company, StroyMedInvest. It will supply, install, and provide engineering support for medical equipment, including network and facility design, for healthcare facilities in Russia and abroad, according to the state corporation's press service.
Product selection and digital solution services are planned to be provided through a single-window approach on a digital platform where potential customers can submit requests for medical equipment and related turnkey services. The service is expected to launch in 2026. According to its creators, this will reduce the design time for medical organizations by automating and integrating all stages of the work and reducing the likelihood of errors at all stages of project implementation. Furthermore, the platform will ensure compliance of supplied medical devices with design documentation and regulatory requirements.
The project is not only aimed at the domestic market: Rostec expects it to be in demand in countries across Asia, the Middle East, and Latin America, where healthcare systems are being actively modernized. Customers will be offered primarily Russian diagnostic and treatment equipment, including those produced by the state corporation.
In Russia, the state is the main client and investor in the construction of medical facilities. Meanwhile, completion dates for large projects can be delayed for years, and due to economic instability, medical construction projects are constantly becoming more expensive, Sergey Furmanchuk, CEO of the Russian engineering group Hosser, told MV.
Other
The FDA has authorized companies to use patient data without consent when submitting applications
The US Food and Drug Administration (FDA) has authorized manufacturers to use anonymized data from real-world clinical practice when submitting drug and medical device approvals without patient consent, according to a press release.
FDA Commissioner Marty Makary, in an interview with Fox News, stated that the reform will speed up the approval process for breakthrough treatments and reduce the costs of their development. As a result, it is claimed, these products could become cheaper for Americans.
This new regulation will give pharmaceutical and medical companies access to the medical records of millions of people. They will have access to national registries of cancer and cystic fibrosis patients, databases of hospitals and insurance companies, and electronic health record registries. All personal information must be deleted beforehand.
Previously, the FDA required consent from each individual whose data was to be included in the analysis. This was practically impossible to achieve, which is why, over the past 14 years, only 12 drugs have been approved based on real-world data, the agency's director noted. Since 2016, such data have appeared in only 35 drug registration applications and 250 medical device dossiers, the press service reported.
As Marty Makary emphasized, most new drugs still require classical controlled trials. Drugs for rare conditions may be an exception. He added that if there are doubts about the quality of the data provided, additional evidence of efficacy and safety will be requested.
This month, the FDA announced another easing: two clinical trials are no longer required for a drug to enter the market. One, with convincing evidence of statistical significance, is sufficient.
The EU has agreed on the first reform of pharmaceutical legislation in 20 years
The EU has agreed on the first reform of pharmaceutical legislation in 20 years: companies will receive a guaranteed nine-year monopoly, the regulator will expedite the drug approval process by one month, and will begin issuing registration certificates indefinitely. Vouchers will also be introduced for the creators of antibiotics against superbugs, allowing them to extend exclusivity rights to any drug in the manufacturer's portfolio.
The European Union (EU) has concluded two and a half years of negotiations to update pharmaceutical legislation. The European Parliament and the Council of the EU have agreed on the final text of the reform, the European Medicines Agency (EMA) announced.
The reform guarantees pharmaceutical companies at least nine years of protection from competition in the European market. For eight years, generic and biosimilar manufacturers will not be able to cite clinical trials of original drugs when applying for registration, and after that, they will have to wait another year before sales begin.
The monopoly period can be extended by an additional three years – one for each criterion met: the drug treats a disease for which there are no effective treatments; studies of the therapeutic molecule were conducted in several EU countries; and the development significantly outperforms marketed alternatives in terms of effectiveness.
Work on the reform has been underway since April 2023. The changes are intended to replace the outdated legal framework from the early 2000s (Regulation 726/2004, which established a centralized system for drug registration through the EMA, and Directive 2001/83/EC, which set uniform standards for the quality, safety, and efficacy of drugs for all Member States). For the document to enter into force, it must be formally approved by the two main legislative institutions of the EU—the European Parliament and the Council—and published in the Official Journal.
Tanning bed use linked to eightfold increased risk of melanoma
Scientists from Northwestern University assessed the association between tanning bed use, melanoma risk, and molecular changes in the skin of high-risk adults. The study's results were published in the journal Science Advances.
The analysis showed that melanoma was diagnosed in 5.1% of patients who used tanning beds, compared to 2.1% of those who did not. After adjusting for age, gender, family history of melanoma, and sunburn, tanning bed use was associated with a nearly threefold increased risk of melanoma.
The risk of melanoma increased with the number of tanning bed sessions. Patients with 10-50 sessions were almost three times more likely to develop melanoma, while those with 51-100 sessions were four times more likely. With 101–200 sessions, the risk increased approximately sixfold, and with more than 200 sessions, it increased eightfold compared to the control group.
Tanning bed users were more likely to develop melanoma on multiple body sites and in areas with low cumulative sun damage, such as the lower back and buttocks. In these locations, melanoma was detected in 76.1% of tanning bed users versus 61.2% of non-tanners.
Molecular analysis of skin samples revealed a significantly higher mutational load of melanocytes in tanning bed users. The frequency of melanoma-associated mutations was almost twice as high in them as in control patients and the general population, despite their younger age.
Data from 5,857 adult patients in a high-risk dermatology clinic were analyzed, of whom 2,932 had at least ten tanning sessions in a tanning bed and 2,925 did not. Additionally, molecular analysis of skin biopsies from 11 tanning bed users, nine control patients, and six representatives of the general population was conducted. Outcomes assessed included melanoma incidence, the association between risk and the number of sessions, tumor location, and melanocyte mutational load.
The most common causes of food allergies in adults have been identified
Food allergies in adults can be associated not only with traditional foods but also with a wide range of other food triggers. Severe allergic reactions are often caused by fruits, nuts, and seeds, which were previously considered less dangerous.
Scientists from the University Medical Center Utrecht assessed the frequency and severity of food allergies in adult patients across a wide range of foods. The study results were published in The Journal of Clinical Allergy and Immunology.
Of the 1,085 patients included in the analysis, 66.9% had probable food allergy accompanied by sensitization, while 33.1% had possible food allergy without confirmed sensitization. Participants reported symptoms associated with 192 different foods, with sufficient sensitization data available for 45 foods.
Almost 80% of all reported symptoms were caused by 30 foods. The most commonly reported reactions to possible food allergies were to fruits (68.8%), nuts (63.0%), legumes (39.5%), vegetables (34.0%), and seeds or pits (14.4%).
Severe symptoms associated with possible food allergies were most often reported with seeds or pits (39.8%), fish (39.2%), legumes (34.8%), nuts (31.9%), and crustaceans (31.3%). Fruits were the least likely to cause severe reactions, accounting for 16.5% of cases. However, in absolute numbers, fruits ranked third in the number of severe reactions, particularly tropical fruits such as lychee, papaya, and jackfruit.
In cases of probable food allergy, the most severe symptoms were most often associated with sunflower seeds (80.0%), pine nuts (66.7%), Brazil nuts (60.0%), cashews (57.1%), and pistachios (51.7%).
The authors concluded that food allergies in adults can be caused by nearly 200 different foods, with seeds and pits more often associated with severe symptoms, and fruits with a higher proportion of patients experiencing severe reactions. This underscores the need to evaluate food allergies beyond the traditional "big eight" allergens.
Source: https://medvestnik.ru/content/news/nazvany-samye-chastye-prichiny-pishevoi-allergii-u-vzroslyh.html
New registered medical devices
We publish a list of new medical devices registered from 12.12.2025 to 12.19.2025
Link to the list: [see table in the attachment]
News
