News Digest 17.04.2026 — 24.04.2026
Regulators
Roszdravnadzor has developed regulations for registering medical devices in accordance with EAEU rules
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has prepared administrative regulations for the public service for registering medical devices in accordance with the rules of the Eurasian Economic Union (EAEU). The draft order has been published on the regulation.gov.ru portal and describes the step-by-step procedure, deadlines, list of required documents, and application forms.
The regulations comply with the rules for registering and assessing the safety, quality, and efficacy of medical devices, approved by Resolution No. 46 of the Council of the Eurasian Economic Commission (EEC) dated February 12, 2016. Depending on the purpose of the application, the applicant will be able to receive a new registration certificate, a reissued document with the same registration number, a duplicate, or only an entry in the register in the event of cancellation.
The maximum waiting time for submitting an application and receiving the result is regulated and should not exceed 15 minutes. Service delivery times vary depending on the procedure type: initial registration takes up to 154 business days, amendments to the registration dossier take 90 days, and notification of changes takes 30 days. A duplicate certificate is issued within five days, approval of an expert opinion takes up to 60 days, and document cancellation takes up to 12 business days.
Applications can be submitted in person, through the government services portal, or by mail. In the first case, the request is registered on the day of receipt, while in the second case, it is registered no later than the next business day. A state fee is charged for the government service in accordance with the Tax Code of the Russian Federation, as well as a fee for approval of expert opinions in accordance with the legislation of the EAEU member states. The regulations stipulate inspection of medical device production facilities according to the methodology of the Russian Ministry of Health as a mandatory, accompanying paid procedure.
Earlier in April, the Eurasian Economic Commission approved new guidelines for the inspection of medical device production facilities. The document outlines what inspectors should monitor and how, from design and production to handling patient complaints and post-registration monitoring. According to the recommendations, inspections are focused on assessing the quality management system across five key areas: design and development, documentation and record management, production and final inspection, corrective and preventive actions, and customer-facing processes. For each area, checklists with 26 tasks have been prepared, using the phrases "must be verified" and "be assured" to describe the evidence inspectors should collect.
A simplified procedure for importing goods from the EAEU without labeling will not affect medicines and medical devices
The President of the Russian Federation has simplified the import of goods from the EAEU without labeling until May 31, 2026. Labeling is now permitted in temporary storage warehouses. This procedure does not apply to pharmaceuticals and medical devices.
Russian President Vladimir Putin signed Decree No. 261 of April 20, 2026, "On the specifics of customs regulation at the state border of the Russian Federation."
According to the document, until May 31, 2026, Russian legal entities and individual entrepreneurs (IEs) importing goods from Eurasian Economic Union (EAEU) states have the right to declare goods without documents confirming their status as union goods, as well as without the mandatory labeling and information required by Russian and EAEU law.
Confirmation of the origin of cargo and the necessary markings can be applied after crossing the border. Goods imported without confirmation must be placed in temporary storage warehouses under customs supervision. The recipient is responsible for transporting the goods to these warehouses, storing them there, and then marking them in accordance with Russian requirements. Customs authorities, in turn, accompany the vehicles to the warehouses.
Furthermore, after marking, the importer is required to notify Rospotrebnadzor (Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing) of the release of the goods into circulation. These exemptions do not apply to certain product groups, as well as narcotic, psychotropic, potent, and toxic substances.
Exceptions include pharmaceuticals (Group 30 of the EAEU Commodity Nomenclature of Foreign Economic Activity), provitamins and vitamins, natural or synthetic, and their derivatives (Item 2936 of the EAEU Commodity Nomenclature of Foreign Economic Activity), as well as narcotic, psychotropic, potent, and toxic substances. In addition, the simplified procedure does not apply to the following medical devices:
- 9018 in the EAEU TN VED — instruments and devices used in medicine, surgery, dentistry, or veterinary medicine (including diagnostic equipment, syringes, scalpels, endoscopes, dental drills, etc.);
- 9019 in the EAEU TN VED — devices for mechanotherapy, massage devices, devices for determining functional parameters of respiration, oxygen therapy, artificial respiration, and other therapeutic breathing devices;
- 9021 in the EAEU TN VED — orthopedic devices (including crutches, surgical belts, corsets), splints, prostheses (dental, limb, eye, etc.), hearing aids, pacemakers;
- 9022 in the EAEU TN VED (Commodity Nomenclature of Foreign Economic Activity) — devices based on the use of X-ray, alpha, beta, or gamma radiation (X-ray tomographs, mammographs, radiation therapy devices, as well as tubes, generators, screens, etc.).
Market news
Compression garment production launched in Technopolis Moscow SEZ with 250 million rubles
Moscow Deputy Mayor for Transport and Industry Maxim Liksutov announced that production of medical compression garments has launched in the Technopolis Moscow special economic zone (SEZ). Moscow-based Elastic Technologies allocated 250 million rubles for the project. The facility will be able to produce up to 360,000 items annually.
The Moscow Fund for Support of Industry and Entrepreneurship provided the company with preferential financing, including interest rate compensation for the investment loan. The production of hospital and medical compression hosiery is located on a 1,300 square meter site. The production lines include high-speed knitting machines, auxiliary equipment, and laboratory equipment.
Elastic Technologies CEO Anzor Boriev noted that the facility uses a unique knitting technology and special materials. The solution enables the production of products with predetermined, graduated compression. The company also plans to expand its product range, including bandages and orthoses.
The products manufactured at the plant are expected to replace imports of medical compression products previously supplied from Germany, Switzerland, Italy, Turkey, and China.
The launch of mandatory labeling for medical gloves has brought dozens of suppliers out of the shadows
The medical glove labeling project, designed to protect the market from counterfeit products, has uncovered dozens of "gray" importing companies. The actual number of participants in foreign economic activity turned out to be 2.3 times higher than previously estimated, Yegor Zhavoronkov, head of the Department of Social Products at the Center for the Development of Advanced Technologies (CRPT, operator of the Honest Sign labeling system), reported at the 15th PharmPRO2026 Pharmaceutical Forum.
Before the introduction of mandatory labeling, Roszdravnadzor had information on 61 importers of these products. After the system's launch, 140 companies registered in the state information monitoring system (GIS MT). This means that several dozen suppliers previously operating in the "gray" zone are forced to legalize their activities and operate transparently, a CRPT representative stated. The figures presented, he said, prove that labeling improves the health of the market and significantly reduces the risk of encountering counterfeit products.
Mandatory labeling of medical gloves within the system was introduced in Russia on March 1, 2025. The requirement applies to latex, nitrile, and vinyl gloves, including sterile and non-sterile options. Initially, the Russian Ministry of Industry and Trade proposed adding identification to them starting March 1, 2024. At the time, the ministry explained that market participants themselves requested the inclusion of this type of medical device in the system. The high proportion of counterfeit products in Russia and the prevalence of unscrupulous "repackagers" were cited as reasons for this, MV reported.
Other
Roszdravnadzor has announced the amount of fines issued for 2025
The total amount of fines for administrative violations identified by Roszdravnadzor exceeded 16 million rubles. A total of 22,200 violations were recorded during 69,000 inspections. The service continues to shift its focus from inspections to prevention: 62,300 inspections were preventive and only 6,700 were inspection and supervision, according to a decision of the Roszdravnadzor board, which was reviewed by MV.
Nearly 2 million medical devices and over 650,000 packages of substandard medications have been withdrawn from circulation. The rights of over 10,200 people to receive high-quality and safe medical care and 9,300 to subsidized drug provision have been restored.
As part of the digitalization program, all 20 of Roszdravnadzor's public services have been converted to electronic format. In 2025, more than 2,300 inspections and preventive visits were conducted using the Inspector mobile app. The service's priorities include integration with Russian Post email and the Unified State Services (POS) feedback platform, as well as providing data from the register of medical devices introduced into circulation to procuring organizations via the Max messenger.
The most in-demand services of Roszdravnadzor include:
- licensing of certain types of activities (56,500 applications);
- state registration of medical devices (11,300);
- introduction of medical devices into civil circulation (over 6.5 billion units);
- the "Information on Medicines Put into Civil Circulation in the Russian Federation" service (347,000 batches).
Russia Approves GOST Standard for Medical Bioprinting
The Federal Agency for Technical Regulation and Metrology (Rosstandart) has approved a bioprinting standard. GOST R 72595-2026, "Three-Dimensional Bioprinting of Tissue and Organ Equivalents. Basic Principles. Terms and Definitions," was developed by the National University of Science and Technology MISIS (NUST MISIS) with the participation of the BioTech2030 Technology Platform Association and the 3D Bioprinting Solutions Biotechnology Research Laboratory.
Rosstandart clarified that the new GOST establishes terms and definitions used in science, engineering, and production in the field of 3D bioprinting and related technologies, and also enshrines the basic principles of the technology, forming the basis for "the systematic development of one of the most promising areas of modern biomedicine." This includes the creation of tissue and organ equivalents using naturally occurring biological materials to restore lost bodily functions.
The document outlines requirements for bioinks—they must provide the necessary rheological (determining behavior during deformation) and biological properties for the formation of three-dimensional structures. The new GOST also enshrines the concept of a bioprinter as a hardware and software system enabling the layer-by-layer creation of objects based on a digital model.
Rosstandart emphasizes that the adoption of the document creates the conditions for the development of transparent mechanisms for the commercialization of research and development, the transition from disparate laboratory solutions to industrial implementation and serial production of biomedical products, and facilitates the integration of Russian developments into the global context. This includes interaction with international partners, including pharmaceutical companies interested in alternative drug testing methods.
"The document lays the foundation for the development of a new industry, providing uniform operating rules for existing market participants and future technology companies," the statement reads. The GOST standard comes into force on September 1, 2026.
Late last year, a 3D-printed cornea was transplanted for the first time in Israel to an elderly patient who had lost sight in one eye. The cornea was printed from cells of a deceased donor with no chronic conditions. The process involved growing cells, printing the tissue, maturing it, freezing it, and shaping the implant. Ultimately, the implant was indistinguishable from a natural cornea in terms of transparency and mechanical properties.
Source: https://medvestnik.ru/content/news/v-rossii-utverjden-gost-po-biopechati-dlya-mediciny.html
A diabetes patient registry has launched in Russia
A diabetes patient registry has been launched in Russia. It contains information about each patient, as well as generalized data. This was reported by RIA Novosti, citing a government document.
The registry contains information on the hypoglycemic medications prescribed to each patient (dosage, frequency, and frequency of administration), as well as on the medical devices used for blood glucose monitoring and insulin pump implantation. It also includes data on the date of detection of diabetes complications.
The summary data includes percentage data on the coverage of patients with diabetes with medications and blood glucose monitoring.
The registry also includes data on the proportion of children aged two to 17 years and pregnant women with diabetes provided with medical devices for continuous blood glucose monitoring. Furthermore, the summary data includes data on patients with diabetes who have not experienced complications for one year.
Since March 2026, according to a document approved by the Russian Ministry of Health, Russia has been maintaining a federal registry of patients with specific diseases, which includes patient information across 12 groups of diagnoses and conditions.
New registered medical devices
We publish a list of new medical devices registered from 04.17.2026 to 04.24.2026
Link to the list: [see table in the attachment]
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