News Digest 24.10.2025 — 01.11.2025
Regulators
94 medical devices will be added to the localization point system
The Russian Ministry of Industry and Trade plans to expand the list of medical devices subject to assessment using the localization point system. The list will include 94 new medical devices (MD) and technical rehabilitation equipment. The criteria for most items will become stricter each year. If adopted, the draft Russian Government resolution, published on regulation.gov.ru, will enter into force on January 1, 2026.
The list of medical devices whose country of origin will be confirmed using the point system will include iodine-125 microsources, disposable vacuum tubes, osteosynthesis implants, several types of materials, equipment, and dental products, rubber gloves, orthopedic footwear, joint, limb, and blood vessel prostheses, and more.
The required number of localization points for classifying certain medical devices as domestically produced will increase each year. For example, for limb joint endoprostheses made of organosilicon rubber, the required number of points will increase from 40 in 2026 to 100 in 2030. For rubber gloves, condoms, and limb joint endoprosthesis components made of steel and alloys, the number of points will remain constant.
For some types of medical devices, additional points can be awarded for complying with the component cost percentage requirement. For example, 10 points will be awarded starting January 1, 2027, for upper and lower limb prostheses if the cost of foreign components (excluding those used for prosthetic sockets) does not exceed 49%.
Amendments are planned to be made to Russian Government Resolution No. 719 of July 17, 2015, "On Confirmation of the Manufacture of Russian Industrial Products." For certain types of medical devices, the current version of Resolution No. 1875 provides for a transition period until June 30, 2026, during which manufacturers will be able to be included in the register of Russian industrial products in accordance with the new requirements stipulated by the draft resolution, effective January 1, 2026.
Previously, the Federal Antimonopoly Service (FAS) called for genuine import substitution with the transfer of key technological processes. Currently, according to the service, some manufacturers are taking a pro forma approach to localization, receiving points for reworking plastic housings or wires.
Russia to extend special rules for the circulation of medicines and medical devices until the end of 2027
The Russian Ministry of Health has developed amendments to the Federal Law "On the Circulation of Medicines" and two Russian Government resolutions aimed at extending the simplified procedure for registering medicines and medical devices. The documents were published on October 27 on regulation.gov.ru.
Article 47 of Federal Law No. 61-FZ of April 12, 2010 "On the Circulation of Medicines" is proposed to be extended until the end of 2027. This is intended to ensure the import and circulation of medicines registered in foreign countries into the Russian Federation in the event of a shortage or the risk of a shortage due to the imposition of restrictive economic measures against Russia.
It is also proposed to extend the validity of Russian Government Resolution No. 593 of April 5, 2022, "On the Specifics of the Circulation of Medicines for Medical Use in the Event of a Shortage or Risk of a Shortage of Medicines in Connection with the Introduction of Restrictive Economic Measures Against the Russian Federation" until December 31, 2027. Amendments to Resolutions No. 430, 441, and 552, regulating the circulation of medicines and medical devices, propose extending the validity of registration certificates and permits until January 1, 2036. The decision on state registration of maximum selling prices for medicines on the List of Vital and Essential Drugs is also expected to be extended until this date.
Earlier, Roszdravnadzor reported an increase in the number of citizen complaints regarding the availability of medicines and medical devices. This year, the number of such complaints has increased by 18%. 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 regarding medical care in the country, MV reported.
NMIC status may become available to pharmaceutical companies
The Russian Ministry of Health has proposed enshrining the status of national medical research centers (NMICs) in the law on the fundamentals of public health protection. According to Vedomosti, the government commission on legislative activity has approved the initiative.
The procedure for granting and terminating NMIC status, as well as the criteria for selecting organizations applying for this status, will be determined by the government. Government organizations holding the status of National Medical Research Centers as of January 1, 2025, will retain this status for six months after the law comes into force or until the government decides to grant them a new status.
The main requirement for organizations to obtain National Medical Research Center status is conducting scientific and technical research in healthcare. One of the centers' primary responsibilities will be to provide methodological support to regional medical organizations.
According to the document, National Medical Research Centers will be able to analyze lists of vital and essential drugs, collect and analyze information on the prescription and use of drugs outside of their approved indications, as well as on the use of unregistered drugs and medical devices.
Furthermore, the centers will calculate the need for drugs used in government programs, taking into account standards and clinical guidelines. This data will help generate requests for the development of new drugs and medical devices, including as part of the import substitution program.
As Alexander Safonov, professor at the Financial University, told reporters, the status of National Medical Research Centers was already enshrined in a separate order from the Russian Ministry of Health in 2021. According to the law, any organization engaged in scientific or scientific-technical activities and under the jurisdiction of the Russian Ministry of Health may apply for this status. Under the new bill, organizations under the jurisdiction of federal and regional government bodies may also apply for NMIC status.
"Perhaps, after the law is passed, it will be possible to assign this status to commercial organizations engaged in medical activities and having specialized centers, for example, in the pharmaceutical field," the expert shared.
Market news
The Federal Antimonopoly Service (FAS) plans to weaken antimonopoly immunity for medical device manufacturers
The Federal Antimonopoly Service (FAS), together with the Russian government and the State Duma, is discussing weakening the antimonopoly immunity that allows medical device manufacturers to avoid complying with competition law. This will help lower prices for products protected as intellectual property. This is not about violating such rights, but rather combating their abuse by monopolists with unreasonably high prices, explained FAS Deputy Head Timofey Nizhegorodtsev at the "National Healthcare" congress, according to an MV correspondent.
The fight against antimonopoly immunity will facilitate further localization of production. However, the localization scoring system should not be taken as an indicator of the actual degree of import substitution for foreign products, noted Timofey Nizhegorodtsev. The FAS has already issued several negative opinions on projects in which the remanufacturing of plastic housings or wires was presented as Russian production in order to obtain preferential bidding. This leads to economic damage to the healthcare system, he noted.
According to the FAS representative, true localization should involve the transfer of key technologies so that preferences are given to those manufacturers who truly need them. However, one should not expect Chinese manufacturers, who have replaced their European and American partners, to be interested in transferring key technologies. Their behavior in other markets indicates a desire for maximum profit, emphasized Timofey Nizhegorodtsev.
The FAS is concerned about the use of government procurement as an incentive for industrial development. Currently, many Russian manufacturers perceive the opportunity to participate in such tenders as the sole criterion when deciding whether to begin production. When concluding offset contracts, the interests of the country, not just the region, must be taken into account. Production facilities already existing in Russia should not be included in offset contracts. "We should not disrupt industrial policy in the Russian Federation by destroying production in Ryazan so that it can open elsewhere. We do not live within regions; we live within a large country," emphasized Timofey Nizhegorodtsev.
Before entering into an offset contract, regions are advised to contact the Russian Ministry of Industry and Trade. "We will advise whether such products exist, whether they are being produced elsewhere, and in what volume. The regions don't see the scale of everything happening in the country," added Ekaterina Priezzheva, Deputy Minister of Industry and Trade. Without such consultation, there is a risk that the funds from the offset contract will not be enough to ramp up production. As a result, manufacturers are applying for support measures, but the ministry is forced to deny them.
Regions should also avoid trying to save money in government procurement by using codes in the Catalog of Goods, Works, and Services (KTRU) that differ from the codes in the Nomenclature Classification of Medical Devices (NKMI) specified in the standards for equipping medical organizations. Law enforcement agencies interpret this as abuse of authority or misuse of funds, initiating criminal proceedings. NKMI and KTRU codes must be coordinated; this is the responsibility of Roszdravnadzor and the Russian Ministry of Health.
The government previously approved the National Competition Development Plan for 2026–2030, MV reported. It plans to complete the digitalization of procurement appeals, develop regional roadmaps, and launch several new modules of the state information system for the prevention, detection, and suppression of anti-competitive agreements (GIS "Anti-Cartel").
Other
Eli Lilly and Nvidia have agreed to build the pharmaceutical industry's most powerful supercomputer
American pharmaceutical company Eli Lilly has signed an agreement with chip manufacturer Nvidia to jointly build the pharmaceutical industry's most powerful supercomputer, according to a press release.
Construction is scheduled for completion in December of this year. The new computing machine will reportedly be assembled from more than 1,000 Nvidia Blackwell Ultra graphics processing units (GPUs), the latest series of chips. They will be connected by a single high-speed DGX SuperPOD network based on Spectrum-X Ethernet. This will enable data processing at over 9,000 petaflops—7 million times faster than the Cray supercomputer Eli Lilly used in 1992.
The main goal is to reduce drug development time, which currently stretches to over ten years. The technology will also speed up clinical trials, manufacturing processes, and diagnostic procedures.
The supercomputer has been dubbed an "AI factory." It will train neural networks for specific tasks: monitoring production to predict equipment failures, preparing various documents, and analyzing medical images. This will be done using the pharmaceutical giant's $1 billion database, which contains all of Eli Lilly's research over 150 years.
It is stated that smaller companies will be able to access these AI models, provided their developments remain confidential.
Eli Lilly's Chief Information Officer, Diogo Rau, emphasized in an interview with CNBC that quick results should not be expected. Computing power of this scale will not bear fruit until 2030.
Drug development typically takes more than ten years and over $2 billion, with 90% of these drugs never reaching market. Reuters cites Jefferies forecasts that spending on AI research in the pharmaceutical industry will grow to $30-40 billion by 2040.
Roskomnadzor Proposes Changing the Approach to Personal Data Processing
Roskomnadzor (RKN) head Andrey Lipov proposed introducing industry standards for personal data processing instead of consent. According to him, as quoted by Interfax, the consent system for personal data processing is "extremely outdated."
"It [the consent system for personal data processing] was probably effective at the outset of Federal Law No. 152 on Personal Data Processing, when it left the content of the consent to the discretion of the individual and the company that asked them to sign it," Lipov stated.
He explained that over time, the number of consents given by users has become so large that they are unable to control them. Therefore, if a person has doubts about the legality of the use of their personal data, it will be difficult for them to defend their rights.
The head of the agency proposed moving from individual consents to industry regulation and the establishment of industry standards. In this case, one set of personal data would be required for companies in, for example, the tourism industry, and another for the education sector.
Initially, the regulations will be developed at the level of the relevant agencies and tested in practice. Then, according to Andrey Lipov, it will be possible to move on to organizing control and oversight to ensure that personal data is collected in the required volume and processed within the specified timeframe.
Roskomnadzor has submitted these proposals to the Russian Government for inclusion in the second package of anti-fraud measures. It will be submitted to the State Duma for consideration during the fall session.
New registered medical devices
We publish a list of new medical devices registered from 10.24.2025 to 11.01.2025
Link to the list: [see table in the attachment]
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