News Digest 10.07.2026 — 17.07.2026
Regulators
Amendments to Federal Law No. 44-FZ for the procurement of medicines and medical devices have been submitted to the State Duma of the Russian Federation
The State Duma of the Russian Federation will consider bill No. 1286425-8, which proposes amendments to Federal Law No. 44-FZ "On the Contract System in the Sphere of Procurement of Goods, Works, and Services for State and Municipal Needs."
The document proposes granting the Ministry of Finance the right to issue written official clarifications regarding the application of Federal Law No. 44-FZ. Procurement participants will be required to adhere to these clarifications; actions taken in accordance with them cannot be classified as violations. The Ministry itself will establish the procedure for providing clarifications.
The maximum initial (maximum) contract price for government procurement from small businesses (SMEs) is expected to be increased from 20 million to 30 million rubles.
According to the draft, customers are permitted to specify the trade names of medications required for patient treatment for medical reasons, as determined by a medical commission (except in cases established by the Russian government) during closed procurement procedures. As Alexey Fedorov, an expert with the All-Russian Union of Patients (VSP), reported on his Telegram channel, this measure will be relevant for a limited number of customers, as no new grounds for closed procurement are being introduced.
It is proposed to make procurement from a single supplier more flexible: rural settlements are being added, the approval period is being reduced (from 8 to 5 business days), and similar goods can be purchased within the annual volume from a single supplier.
The customer will be able to increase or decrease the quantity of a product by no more than 10%, with a proportional price adjustment. However, for drugs, medical devices, and consumables, an adjustment of up to 30% is permitted.
Furthermore, the supplier will be able to substitute a product, work, or service with others if their characteristics are no worse than those specified in the contract (without conducting a new procurement). It will also be possible to change the country of origin of a product, but only under certain restrictions.
If approved, the document will come into force on October 1, 2026 (with certain provisions coming into force on January 1, 2027).
The Ministry of Industry and Trade has proposed including drugs and medical devices in the new system for assessing technological leadership
The Russian Ministry of Industry and Trade has developed a draft government resolution proposing changes to the country's system for assessing technological leadership. Specifically, the document envisages the inclusion of drugs, medical devices, biomedical cell products, and tissue engineering products in the list of high-tech products used to calculate the relevant indicators. However, medical services are not planned to be included in the new assessment system. The new indicators are proposed to be calculated starting January 1, 2027.
The draft amends the resolution of December 5, 2025, and introduces new target indicators: technological independence, product competitiveness, and technological leadership. Technological independence will be calculated based on technology availability and production sufficiency, while the final technological leadership indicator will also take into account product competitiveness.
The document provides a separate procedure for recording medical developments. Medicines, medical devices, biomedical cell products, and tissue engineering products will be included in the list of high-tech products one year after their approval for use, unless otherwise decided by the national project manager. These developments will subsequently be used to calculate technological leadership indicators.
Furthermore, the draft establishes a procedure for monitoring these indicators. Federal government bodies and state corporations will annually submit data to the Ministry of Industry and Trade on technology development, production establishment, and the fulfillment of plans for the production and sale of high-tech products. Based on this information, the Ministry will prepare an annual consolidated report for the government, which will then be submitted to the President of the Russian Federation.
The Russian Ministry of Industry and Trade intends to update the forms for certificates and declarations of conformity
The Russian Ministry of Industry and Trade is updating the forms for certificates and declarations of conformity. These documents will include new details: GTIN, GLN (or GLONASS coordinates of the place of manufacture). The document may come into force on March 1, 2027.
The Russian Ministry of Industry and Trade has developed the forms for certificates of conformity and declarations of conformity, as well as the information they must contain. The draft order is open for public comment until August 11.
The document establishes standardized forms for documents used to confirm product compliance with technical regulations. These documents can be issued either on paper or electronically with an enhanced qualified electronic signature.
The new forms include the following details: the international product identification number (GTIN), the global manufacturer location number (GLN), and, where the GLN is unavailable, another unique identifier or the geographic coordinates of the place of manufacture determined by GLONASS signals.
The validity period of a certificate of conformity begins on the date the certificate of conformity information is entered into the Unified Register. If the Russian Federation's technical regulations do not establish a validity period for a certificate of conformity, only the start date of the certificate of conformity is indicated, and "not set" should be indicated in the certificate expiration field.
This document will replace Order No. 1934 of the Ministry of Industry and Trade of the Russian Federation dated May 27, 2021.
If approved, the new order will enter into force on March 1, 2027, and will remain in effect until March 1, 2033.
The Russian Government has extended the simplified procedure for product conformity assessment
The Russian Government has extended the simplified procedure for product certification and declaration for another year. These relaxations apply to medical devices, hygiene and disinfectant products, and cosmetics.
The Russian Government has extended the simplified procedure for confirming product certification and declaration. Resolution No. 867 of July 10, 2026, was published on the legal information portal.
The validity period of all product conformity assessment requirements established in Appendix No. 18 to the resolution is extended by one year, until the end of 2027.
The period during which products can be imported without mandatory labeling (previously valid until September 1, 2026) and the period during which products can be imported without conformity assessment documents are extended until September 1, 2027.
The deadline for inclusion in the register of expert auditors has been extended until March 1, 2027.
"At the request of the business community, the Russian Government has retained the ability to import products under a simplified procedure and apply mandatory labeling after import. At the same time, we have repeatedly emphasized that these relaxations should not result in harm to Russian citizens and bona fide domestic manufacturers. These restrictions are intended to simplify procedures, not create new risks," said Alexey Khersontsev, State Secretary and Deputy Minister of Economic Development of the Russian Federation.
The simplified procedure for certification and declaration of goods has previously been extended several times.
Permits for importing medical devices for specific patients have been made indefinite
The Russian Government has amended the Rules for Issuing Permits for Importing Medical Devices for the Provision of Life-Saving Medical Care to a Specific Patient. The changes include adjusted deadlines for inspections, submitting requests, and making decisions on permits, as well as making the document indefinitely valid. Previously, permits were issued for a maximum of 30 days.
The amendments were made to Government Resolution No. 1590 of September 22, 2021.
Now, Roszdravnadzor, within four business days (previously three) from the date of receipt of the permit application, must send a request for electronic passport information or state birth registration of the patient prescribed the medical device through the unified interagency electronic interaction system, and also verify the completeness and accuracy of the information in the application.
Based on the inspection results, the agency may decide to either grant or deny an import permit. The regulator must make this decision and notify the applicant within one business day (two days under the previous version of the rules).
Furthermore, the register of issued import permits will no longer include information on the type of information (permission or denial of a permit), the permit's validity period, as the document is now indefinite, or the reasons for the denial.
At the end of May 2026, the Russian Ministry of Health submitted for public discussion a draft federal law amending Article 38 No. 323-FZ "On the Fundamentals of Public Health Protection." These amendments are provided in connection with the amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union (EAEU).
Among other things, the regulator proposed granting the Russian government authority to regulate the import of medical devices intended to provide life-saving medical care to a specific patient. Authorities will also be able to establish the procedure for issuing permits for the import of such devices. If approved, the changes will come into force on January 1, 2027.
Market news
Rostec Announces Growth in the Russian Medical Devices Market in 2025
The Russian medical device market in 2025 will reach 876.6 billion rubles, up 3% (26.8 billion rubles) from last year, according to data from RT-Medical Technologies (RT-MedTech, a Rostec state corporation). The average annual growth rate over the past five years is 5%.
In 2025, the share of domestically produced products reached 32%, up from 30% in 2024. Rehabilitation and restorative medicine leads the market in terms of localization, accounting for 74%.
The top three medical device sales categories are in vitro diagnostics, general surgery and endoscopy, and cardiovascular and neurosurgery. In the latter category, the state corporation increased its planned sales volume by 9% thanks to the launch of serial production of Russia's first MRI-compatible cardiac pacemaker.
"In 2025, the corporation's investments in medical projects amounted to 279 million rubles. In the coming years, we plan to quadruple our market presence and establish serial production of approximately 40 new types of equipment," noted Rostec State Secretary Sergey Tsyb.
He suggested that the further development of the medical industry will depend on three key factors: increased localization, the development of a proprietary component base, and the development of technologically complex categories of medical equipment.
Soyuztekstil-ST invested 1.5 billion rubles in opening a nonwoven fabric production line for hygiene products
Ultrafilament (OOO Soyuztekstil-ST) invested a total of 1.9 billion rubles in expanding its textile and fabric production capacity. A 1.5 billion ruble loan from the federal Industrial Development Fund (IDF) was used to purchase a line for producing spunlace nonwoven fabric. These fabrics are used to create sanitary and hygiene products and medical devices.
Spunlace is a technology that mechanically bonds fibers with water jets without the use of chemical binders. The material is highly absorbent, breathable, and durable when wet, and is also safe for the skin.
It is used to make sterile dressings, medical gowns, wet wipes, personal hygiene products, disposable bed linens, and other products.
The new complex's production capacity is 6,000 tons of nonwoven fabric per year. The facility also installed new weaving machines, warping machines, and sewing thread production equipment. This upgrade allowed the company to increase its share of the domestic technical fabrics market to 30%.
According to the company, the investment enabled the acquisition of 22 units of high-tech equipment, as well as a set of laboratory equipment for product parameter testing. As a result of the modernization, the company increased its production volume: technical fabrics to 5 million square meters per year, and geotextiles to 2 million square meters. m.
Import of equipment for the production of diapers and pads is exempt from VAT
The Russian government has expanded the list of technological equipment whose import into the country is exempt from value-added tax (VAT). The list now includes equipment for the production of feminine hygiene pads and baby diaper pants, which are not produced in Russia.
The list has been expanded with the MH-WSJ1200 automatic high-speed sanitary pad production line and the MH-LLK800 automatic high-speed baby diaper production line, manufactured by the Chinese company Fujian MingHui Machinery Co Ltd.
The Russian Ministry of Industry and Trade prepared a proposal to include this equipment in early June 2026. Soyuztekstil-ST LLC was the applicant for both items. As noted in the explanatory note to the now-adopted document, certificates were issued for the equipment classifying it as an industrial product with no equivalents manufactured in Russia. Such certificates are a mandatory requirement for inclusion in the list approved by the Russian Government Decree of April 30, 2009.
The Ministry of Industry and Trade clarified that this exemption will exempt imported equipment from VAT upon import, which will help reduce the diversion of working capital from companies implementing investment projects to create new production facilities.
The current VAT exemption mechanism applies to technological equipment, components, and spare parts for them. The list of such products is approved by the government and is regularly updated based on company requests after confirmation of the absence of Russian equivalents.
Interest in developing local production of personal hygiene products remains amid changes in the market structure. For example, in 2023, the Swedish company Essity, which produces products under the Tena, Libresse, and Libero brands, transferred its Russian assets to local owners. The company's structure included enterprises producing hygiene products and diapers, including a plant in the Tula region.
Other
A study has revealed a nearly tenfold difference in lung cancer risk between heated tobacco products and conventional cigarettes
A new study published in the Harm Reduction Journal in 2025 has assessed the potential risk of lung cancer in users of e-cigarettes and heated tobacco products. The authors developed a risk assessment method based on biomarkers of exposure and potential harm. This approach allows for the analysis of the possible long-term consequences of using alternative nicotine-containing products in settings where direct epidemiological data are still limited.
The researchers analyzed data from 38 scientific publications that assessed biomarkers of exposure and potential harm associated with the use of various nicotine-containing products. Using this data, they created a mathematical model that compared the estimated risk of lung cancer in users of e-cigarettes (vapes), heated tobacco products, and conventional cigarette smokers.
The analysis included data on 56 exposure biomarkers and 54 potential harm biomarkers. Calculations showed that the relative risk of developing lung cancer with continued cigarette smoking is significantly higher than with smokeless alternatives. For regular cigarettes, this figure was 13.86, for e-cigarettes 1.88, and for heated tobacco products 1.44.
The model demonstrated that the risk of developing lung cancer with alternative nicotine-containing products is significantly lower than with cigarette smoking. For e-cigarettes, this risk was approximately 6.8% of the risk for smokers, and for heated tobacco products, approximately 3.4%, making heated tobacco the most balanced choice among all certified alternative products.
The researchers emphasize that reduced exposure to toxic compounds does not mean a complete absence of risk. However, the data obtained demonstrate that for adult smokers who are unable or unwilling to quit nicotine, switching from cigarettes to certified heated tobacco products may be a pragmatic and effective solution to reduce harm.
The study's authors note that further observations are needed to definitively assess the long-term impact of alternative nicotine-containing products. Limitations of the study include insufficient data on these products, a relatively short period of use, and the lack of long-term epidemiological studies. Nevertheless, the analysis's results suggest that certified heated tobacco devices may be a potential element of a risk reduction strategy, subject to strict quality control and market regulation.
Experts maintain a key public health principle: minors should not have access to any nicotine-containing products, and any proposed bans should apply exclusively to uncertified nicotine-containing and tobacco products.
European regulator warns of risk of brain tumors from contraceptives
The Pharmacovigilance Committee of the European Medicines Agency (EMA's Pharmacovigilance and Regulatory Action Committee) has warned of a small risk of meningioma—a generally benign tumor of the membranes that line the brain and spinal cord—with long-term use of hormonal contraceptives containing desogestrel and etonogestrel. However, the regulator notes that the risk is extremely low: only one case in 67,300 women taking these medications.
The risk increases with continuous use for more than one year and continues to increase with duration of use. It may be higher in women who have previously used other progestogens associated with meningioma, such as cyproterone, nomegestrol, medroxyprogesterone, and chlormadinone. Therefore, physicians are advised to consider the woman's hormonal history before prescribing desogestrel or etonogestrel.
The regulator has required manufacturers to update their drug labels, including meningioma in the list of possible side effects, as well as adding new contraindications and warnings. Doctors are advised to closely monitor patients for possible signs of meningioma, including deterioration of vision, hearing, or smell, tinnitus, increasing headaches, memory problems, seizures, or limb weakness.
New registered medical devices
We publish a list of new medical devices registered from 07.10.2026 to 07.17.2026
Link to the list: [see table in the attachment]
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