News Digest 23.01.2026 — 30.01.2026
Regulators
The regulator will change the timeframe for issuing permits for the use of in vitro diagnostic medical devices.
The Russian Ministry of Health has developed a draft government resolution amending the Rules for Granting, Renewing, Confirming, and Revoking Permits for the Use of Medical Devices Manufactured and Used by Clinics for In vitro Diagnostics. The amendments primarily focus on reducing the timeframe within which Roszdravnadzor issues decisions. For example, a decision on granting or denying permits for the use of unregistered medical devices will be made within 28 business days. The current resolution sets this timeframe at 32 days.
Furthermore, the Ministry of Health proposes excluding the time allotted for medical organizations to amend their applications (if any violations are found) when calculating the final decision timeframe. Currently, this timeframe is set at 20 business days. The ministry also believes it is necessary to change the timeframe for resuming document review (after the violations have been corrected) from three business days to one day.
A decision to confirm or deny an existing permit will be made within 13 business days (currently 14 days). Verification of the completeness and accuracy of the information will take two business days (currently three days), and a decision to begin reviewing the application will be made within one day.
The agency also proposed establishing that applications and required documents will be submitted exclusively electronically through the State Services portal. As a result, provisions regarding inventorying paper documents when submitted in person are removed from the regulations.
In December 2025, Roszdravnadzor presented draft regulations for issuing permits to conduct clinical trials of medical devices for their registration under EAEU rules. The maximum period for providing the service will be 45 business days from the date of registration of the application for clinical trials for medical devices and one day for notification of clinical laboratory testing of in vitro diagnostic medical devices. The regulations have not yet been approved.
The Ministry of Industry and Trade of the Russian Federation proposes introducing labeling for baby diapers and toothbrushes.
The Russian Ministry of Industry and Trade has prepared a draft government resolution providing for the phased introduction of mandatory labeling for certain types of household, sanitary, and hygiene products, as well as toiletries. The list includes products that are important for sanitary and consumer safety, including baby diapers, razors and blades, toothbrushes, and other products that come into contact with skin and are used in daily care. If adopted, the main changes will come into force on September 1, 2026.
Mandatory registration of market participants in the state monitoring system is scheduled for September 1, 2026, with product labeling and submission of information on their introduction into circulation scheduled for October-November 2026, depending on the product category. For razors and blades, the deadline for submitting information on product circulation and withdrawal from circulation is postponed to December 1, 2026, with the corresponding changes coming into force on June 1, 2026.
If the document is approved, the submission of product circulation and withdrawal from circulation data will become mandatory starting in 2027. Individual product accounting outside of retail sales has been postponed until 2030, allowing market participants to gradually adapt their accounting and IT processes to the new requirements.
The draft also provides for a transitional mechanism for imports: for four months after the mandatory labeling start dates, customs may release unmarked goods purchased before the relevant date established for a specific category.
In December 2025, the Ministry of Industry and Trade proposed expanding mandatory labeling for medical devices, including aesthetic medicine products. The list was proposed to include fillers and cosmetic threads, which were previously exempt from mandatory identification requirements, citing the results of voluntary experiments and the increase in illegal trafficking in this segment. These changes have not yet been approved.
The sale of drugs, medical devices, and dietary supplements on marketplaces will be subject to mandatory pre-moderation.
The Russian Ministry of Economic Development has proposed requiring marketplaces to verify the legality of drugs, medical devices, and dietary supplements before publishing listings and to block products that fail the check. Discussion of the draft resolution will last until February 24.
The document details the requirements of Federal Law No. 289-FZ on the platform economy, assigning pre-moderation responsibilities to marketplace operators. According to the draft, product listings will be blocked in cases where:
- a product is offered for sale that has been withdrawn from circulation;
- mandatory registration has not been completed (for dietary supplements, drugs, and medical devices);
- information on the required confirmation of product conformity is missing;
- state registration or labeling information is not provided;
- the seller is not registered in the Honest Sign labeling system for products subject to labeling.
A product listing will only be approved for publication if all verification conditions are met. If a product fails pre-moderation, the operator will block the listing and notify the seller within 24 hours of the reason for the denial. The seller can then correct the information in the listing and submit it for re-verification.
If approved, the document will take effect on October 1, 2026.
Market news
Russia has developed the first classification of digital medical products and services.
The Center for Expertise and Quality Control of Medical Care (CEQMC) of the Russian Ministry of Health has created an original faceted classifier of digital medical products and services (DMPS). It will serve as the basis for standardizing the implementation, circulation, and financing of such solutions in the industry, creating a universal "language" for developers, regulators, and clinics, the center's press service reported.
The classification takes into account the international experience of the World Health Organization (WHO) and the Alliance for Digital Therapeutics, as well as Russian legislation. Its distinctive feature is a multidimensional approach for describing any digital product in medicine across six categories:
- User: patient, healthcare professional, administrator, etc.
- Target: personal health, public health, healthcare organization.
- Purpose/functionality: diagnostics, monitoring, training, document management, etc.
- Platform: PC, mobile devices, wearables, medical devices.
- Operating principle: telemedicine, Internet of Things, decision support systems, robotics.
- AI: presence/absence.
The combination of parameters creates a unique code for any CMPS, simplifying identification, comparison, and integration.
Previously, Russian scientists identified key factors contributing to the accelerated adoption of digital technologies in medical practice. The study shows that doctors are more likely to master such tools if they are provided with free training courses, study leave, transparent legal support, and a clear regulatory framework.
Other
A petition has been launched in Russia to double the time doctors spend with patients.
A petition has been launched on the Russian Public Initiative (ROI) platform to increase the time doctors spend with outpatients to 30 minutes, MV reported. It requires 100,000 votes for federal approval.
The petition's authors emphasize that the current standard—12-15 minutes per appointment—is unrealistic. This leads to poor quality care: doctors don't have time to collect a patient's medical history, conduct an examination, and explain the diagnosis and treatment plan. As a result, patients suffer, including long waiting lists, treatment becomes "symptomatic," and doctors burn out from time pressure and stress.
Amendments are proposed to the Russian Ministry of Health's orders stipulating that a patient's appointment with a general practitioner and pediatrician should be limited to 30 minutes, and with specialists and a neurologist, 40 minutes. To achieve this, it is necessary to shift from per-capita funding of this service to payment based on time or case complexity, increasing compulsory health insurance rates.
Workflow optimization will also be necessary by delegating routine tasks to nurses (documentation completion, preliminary surveys, measuring key parameters, vaccinations, and sample collection) and implementing digital tools (templates in electronic medical records, voice assistants for completing charts, online scheduling, and preliminary patient surveys). Furthermore, it is proposed to revise doctors' schedules, allocating time for them to work with documentation, conduct telephone consultations, and handle emergency cases.
The initiative's authors believe that its implementation could lead to savings for the healthcare system due to fewer repeat visits and fewer diagnostic and treatment errors.
The EU and India have reached a historic agreement to abolish duties on pharmaceuticals.
India will abolish 11% duties on imports of most European pharmaceutical products. The country has signed the largest free trade agreement with the European Union (EU), according to a press release.
According to the European Commission, negotiations to remove trade barriers began in 2007 but were suspended in 2013 and only resumed in 2022. It states that a complete waiver of customs duties on medicines will take up to ten years, but for the majority of them, it will take five to seven years. Additionally, the terms guarantee the protection of intellectual property rights based on current international standards and national legislation, with the aim of facilitating business for pharmaceutical companies in both countries.
Brussels explicitly stated that the motive for strengthening economic ties with New Delhi was "rising geopolitical tensions and global economic challenges." This wording clearly refers to pressure from Beijing and Washington. Europe is trying to reduce its dependence on raw material imports from China while simultaneously facing Donald Trump's aggressive protectionism.
Last year, the US president threatened to impose inflated tariffs on European drugs, forcing corporations to begin relocating production to the US. Although an agreement was later reached to limit the tariff to 15%, the risk of being left without new drugs remains for the European market.
The State Duma has proposed increasing the amount of the tax deduction for medical treatment to 360,000 rubles.
A group of deputies, including Yaroslav Nilov (LDPR) and Nina Ostanina (CPRF), chairs of the Committee on Labor, Social Policy, and Veterans' Affairs and the Committee on Family Protection, Fatherhood, Motherhood, and Childhood, have introduced a bill to the State Duma to increase the maximum amount of expenses eligible for a social deduction from personal income tax (PIT) and expand the list of expenses for which it is available. The initiative is aimed at compensating some of the costs citizens incur on socially significant services, including medical treatment, as well as recreation and recuperation for children.
The proposed amendments are to Article 219, Part 2 of the Tax Code of the Russian Federation. The bill provides for an increase in the total limit on social expenses eligible for a tax deduction from 150,000 to 360,000 rubles per year. If adopted, the document will come into force on January 1, 2027.
According to the bill, the increased limit will apply to expenses on education, treatment, and the purchase of medications, physical education and health services, pension savings, insurance, and independent qualification assessments. However, the current procedure, under which expenses for expensive treatment and certain categories of children's education are considered outside the general limit, remains in place.
A separate provision of the bill proposes to include expenses for children's recreation and health improvement in the list of grounds for social tax deduction. It also clarifies the range of organizations and individual entrepreneurs whose services may be included in the deduction, provided that their primary activity is in the field of physical education and sports.
New registered medical devices
We publish a list of new medical devices registered from 01/23/2026 to 01/30/2026
Link to the list: [see. table in attachment]
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