News Digest 13.03.2026 — 20.03.2026
Regulators
The Russian Ministry of Health intends to abolish paper forms for registration certificates for medical devices
The Russian Ministry of Health has submitted for public discussion a draft order repealing Roszdravnadzor Order No. 40-Pr/13 of January 16, 2013, on the form of registration certificates for medical devices and all amendments made thereto. The document was prepared in accordance with Russian Government Resolution No. 1684 of November 30, 2024, which approved the new Rules for State Registration of Medical Devices and formalized the transition to a registry-based model for issuing registration certificates.
The draft proposes to repeal Roszdravnadzor Orders No. 40-Pr/13 of January 16, 2013, No. 3380-Pr/13 of July 23, 2013, No. 1636 of March 3, 2017, and No. 4510 of July 10, 2017, which regulated the format of paper registration certificates. After the order comes into force, registration certificates for medical devices, including those for applications submitted prior to the effective date of Resolution No. 1684, will be issued as an entry in the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.
This also applies to products for which state registration applications were submitted to Roszdravnadzor prior to the entry into force of Resolution No. 1684.
Russia plans to expedite the issuance of permits for the use of unregistered medical devices
The Russian Ministry of Health has prepared amendments to the rules for issuing, reissuing, confirming, and revoking permits for the use of unregistered medical devices intended for in vitro diagnostics and manufactured and used by the medical organization that produced them. The document, published on regulation.gov.ru, aims to reduce the timeframes for permitting procedures.
One of the key changes is the complete transition to electronic processing of applications and notifications through the State Services portal, using an enhanced electronic signature. Submitting such applications on paper is no longer possible. A separate set of amendments is devoted to the renewal and revocation of permits: applications are also now submitted only electronically.
The draft clarifies the timeframes for all key stages: it reduces the time required to make a decision on granting and confirming a permit, and shortens the time required for the examination and review of applications. Thus, the timeframe for reviewing an application for permit renewal is being reduced from three business days to two (from the date of application receipt); for granting or denying a permit, from 33 business days to 28; for confirming or denying a permit, from 14 business days to 13; for reissuing or denying a permit, from five business days to four; and for revoking a permit based on an application from a medical organization, from ten business days to one. The timeframe for reviewing an application for permit is also being reduced from 30 business days to 25.
At the end of last year, the Russian Government approved new regulations for federal oversight of the circulation of medical devices, including those classified as "high risk." Roszdravnadzor will conduct inspection visits, checks, and test purchases for this category of medical devices at least once every two years. Preventive visits and other oversight activities can be conducted not only in person or via videoconference, but also using the "Inspector" mobile app. High-risk control items include the production and/or manufacture of medical devices, medical devices for in vitro diagnostics, and/or medical devices implanted in the human body.
The Russian Ministry of Health will submit amendments to the agreement on the single market for medical devices for ratification
The Russian Ministry of Health intends to submit for ratification the Protocol on Amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union (EAEU). The draft resolution is undergoing public discussion until March 28.
Deputy Minister of Health of Russia Sergey Glagolev is proposed to be appointed as the official representative of the Russian government during the consideration of the Protocol's ratification by the chambers of the Federal Assembly.
A draft federal law on ratification of the protocol has also been prepared.
This protocol amends Article 11 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the EAEU, dated December 23, 2014. With this document, the Russian government approved a two-year postponement of the transition to uniform rules for the circulation of medical devices in EAEU countries. Registration applications can now be submitted until the end of 2027, and renewals can be made until 2028.
Laboratory reagents banned from export
The Russian government has banned the export of laboratory reagents, approving Resolution No. 257 of March 11, 2026.
Amendments are being made to Russian Government Resolution No. 311 of March 9, 2022. The document approves a list of goods temporarily banned from export. The export ban was initially in effect until the end of 2022, but was subsequently extended several times, most recently until December 31, 2027.
Laboratory and diagnostic reagents (EAEU TN VED codes 3006 70 000 0 and 3821 00 000 0) have been removed from the list of goods permitted for export. Laboratory reagents with code 3822 are now permitted to be exported only without a backing (except for code 3822 90 000 0).
Furthermore, the wording for code 3822, as well as for code 9018, has been amended. Code 9018 now reads as follows:
- "9018 (except for 9018 31 900 1, 9018 49 100 0, 9018 50 900 0) - devices and apparatus used in medicine, surgery, dentistry, or veterinary medicine, including scintigraphic equipment, other electromedical equipment, and devices for examining vision".
Source: https://pharmvestnik.ru/content/news/laboratornye-reagenty-zapretili-vyvozit-iz-strany.html
The concept of medical technology will be introduced into the law "On the Fundamentals of Health Protection of Citizens"
Russia will establish a unified registry of medical technologies and formal rules for their development and approval in healthcare. The Russian Ministry of Health has prepared draft amendments to Federal Law No. 323-FZ "On the Fundamentals of Health Protection of Citizens." The document (published on regulation.gov.ru) introduces the concept of "medical technology" into legislation, along with rules for its development, clinical trials, and a comprehensive assessment of its effectiveness.
The development of a medical technology includes theoretical and experimental scientific justification at the preclinical stage, clinical trials, and the provision of medical care to patients. The developer of a medical technology has the right to engage other organizations in conducting its clinical trial. However, it must first obtain a conclusion from the medical organization's ethics committee on the ethical justification for conducting such a trial and the expected significance of the medical technology's use. A comprehensive assessment of a medical technology includes an analysis of information on its comparative clinical effectiveness and safety, as well as an assessment of its economic and other consequences.
There are only three criteria for including medical technologies in the registry. First, the development must involve a new method of medical intervention or a set of medical interventions, or be intended to perform a medical intervention not previously used in the Russian Federation. Second, the new medical intervention does not consist solely of the use of a medical device, drug, or biomedical cell product. Third, the development of the medical technology applies new principles and patterns established through scientific research, or new combinations of known principles and patterns, or generates new scientific knowledge supported by publications in "highly regarded scientific journals."
The document states that the decision to include a medical technology in the registry is made by Roszdravnadzor based on findings of compliance or non-compliance with these criteria and the results of a comprehensive assessment. The technology must be automatically removed from the registry after five years.
GOST for AI systems in healthcare approved
A state standard for artificial intelligence (AI) systems in healthcare has been approved in Russia. It was enacted by Order No. 1812-st of the Federal Agency for Technical Regulation and Metrology (Rosstandart) dated December 25, 2025, and establishes a classification of such systems.
All systems in the standard are divided into two main categories: medical devices with AI technologies and services based on AI. The first group includes all systems designed by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring the human body, conducting medical research, restoring, replacing, or modifying the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, whose functional purpose is not achieved through pharmacological, immunological, genetic, or metabolic effects on the human body. The second group includes voice services, chatbots, and video analytics services.
Based on the area of application of various technologies, AI systems (AI) are divided into: those using natural language processing technologies; those using big data analysis technologies; those using image processing technologies, etc.
From the end user's perspective, AI systems are divided into the following groups:
- for medical and pharmaceutical workers;
- for administrative and managerial personnel of medical institutions and healthcare systems;
- for healthcare organization and public health specialists;
- for scientists and researchers;
- for educators of educational programs in healthcare and students;
- for patients.
Based on their level of training, artificial intelligence systems in medicine are divided into the following groups: those designed for users without specialized training and those designed for users with training. Autonomous artificial intelligence systems are capable of making independent decisions and performing medical procedures without direct human intervention. "These include systems that can independently perform medical operations and intelligent diagnostic systems that automatically interpret medical images. Such systems must have a high level of reliability and safety," the document specifies.
Source: https://medvestnik.ru/content/news/utverjden-gost-dlya-ii-sistem-v-zdravoohranenii.html
Market news
China Approves World's First Brain Implant for Commercial Use
China's National Medical Products Administration (NMPA) has granted commercial approval for the world's first brain-machine interface. Developed by Shanghai-based Neuracle Medical Technology, the device will help restore hand function in adults with partial paralysis following spinal cord injury, Bloomberg reports.
Thanks to the device, 36 clinical trial participants regained the ability to grasp and hold objects. It consists of several components:
- a coin-sized chip – implanted into a specially cut hole in the skull, where electrodes are placed on the dura mater without compromising its integrity;
- an external receiver – attached to the outside of the head with magnets above the implantation site to provide wireless power transmission (therefore, the implant inside the skull does not require a battery) and transmit digitized neural signals;
- a robotic glove – a pneumatic exoprosthesis that operates by pumping air into special flexible tubes;
- a set of surgical instruments;
- software for decoding brain signals and processing data on the patient's condition and the implant.
However, this system has significant technical limitations: it has fewer channels for capturing signals compared to competitors that are implanted deep within the brain tissue. Therefore, it is only suitable for those with some upper limb function. Meanwhile, American equivalents—for example, from Elon Musk's Neuralink—already allow completely paralyzed people to use the internet and spend their leisure time playing video games.
The development of brain-computer technologies is one of the six priorities of China's state policy in the current five-year plan. Even before such products appeared on the market, Chinese authorities developed a mechanism for reimbursing the costs of their development.
Biorevitalizant manufacturer to expand Novosibirsk plant for 130 million rubles
Biotime (Novye Tekhnologii LLC), a company specializing in the production of hyaluronic acid-based cosmetic products and medical devices, intends to add additional capacity to its Novosibirsk plant. Investment in the project will exceed 130 million rubles, of which 56.5 million rubles will be provided by the Industrial Development Fund (IDF) of the Novosibirsk Region in the form of a preferential loan. The new production line will enable the production of over 100 types of hyaluronic acid-based products and medical devices for cosmetology and aesthetic medicine, as well as intra-articular prostheses.
Analysts have repeatedly noted the scale of the problems in the cosmetology sector. As Forbes reported in early December 2025, the Russian cosmetic injection market could reach 50-52 billion rubles. The consulting firm Right to Health estimated that the volume of illegally sold products already exceeded 10 billion rubles. Annual growth was estimated at 20%. Analysts noted that illegal biorevitalizers, fillers, and botulinum toxins are freely sold on marketplaces, fueling the shadow market and creating risks for patients and legitimate market participants.
That same month, the Russian Ministry of Industry and Trade prepared a draft government resolution expanding the list of medical devices subject to mandatory identification marking. Specifically, it proposed including products for plastic surgery and cosmetology, such as fillers and lifting threads, on the list. If adopted, the new requirements would come into effect on June 1, 2026.
J&J Launches First IL-23 Inhibitor Tablet for Psoriasis
The U.S. Food and Drug Administration (FDA) has approved Icotyde (icotrokinra), the first tablet for psoriasis that blocks the interleukin-23 (IL-23) receptor. It will be used to treat patients over 12 years of age with moderate to severe forms of the inflammatory skin disease, according to a press release.
The drug was developed by Johnson & Johnson (J&J) and Protagonist Therapeutics, a pharmaceutical company that has been collaborating since 2017. It is taken once daily upon awakening.
This more convenient dosage form could transform a market currently dominated by injectable IL-23 inhibitors, such as Skyrizi (risankizumab) from AbbVie and Tremfeya (guselkumab) from J&J. According to Citi analysts, as cited by Fierce Pharma, the development will quickly gain popularity, generating up to $5.5 billion in annual sales. Jefferies offers an even more optimistic revenue forecast of $7.5 billion.
Other
An Australian Man Creates a Cancer Vaccine Using AI and Saves His Dog
Using artificial intelligence (AI), Australian machine learning and data analytics specialist Paul Coningham created a personalized mRNA cancer vaccine for his eight-year-old dog, Rosie, in six months. The drug helped save his pet's life, according to The Australian.
In 2024, Rosie, a Staffordshire Bull Terrier-Shar Pei mix, was diagnosed with mast cell tumor. The tumor rapidly progressed and metastasized. Surgery and chemotherapy slowed the disease but failed to reduce the tumor's size. Doctors gave Rosie one to six months to live.
Coningham, co-founder of Sydney-based consulting firm Core Intelligence Technologies, turned to the AI model ChatGPT, which developed a step-by-step plan. Following a chatbot's recommendation, he sequenced Rosie's tumor and healthy DNA at the University of New South Wales (UNSW) for $3,000.
Based on the resulting nucleotide sequences, three-dimensional structures were modeled using another AI tool, AlphaFold from Google DeepMind. The entrepreneur's proprietary algorithms then compared normal and cancer proteins, identifying neoantigens on their surfaces that would be best recognized by the immune system—these formed the basis of the vaccine.
In December 2025, Rosie received her first injection. A month later, the tennis ball-sized tumor on her paw had shrunk by 75%. Before the vaccination, she could barely walk, but by the end of January, she was easily jumping fences and enduring long walks without quickly tiring.
However, one of the tumors did not respond to the treatment. The Australian is working on a more effective version of the drug.
This is the first-ever personalized cancer vaccine for animals, according to UNSW scientists. According to Paul Thordarson, head of the RNA Institute at the Australian university, Coningham's example highlights the growing accessibility of personalized treatments: a person without specialized training has achieved results that would otherwise cost large manufacturers enormous sums.
New registered medical devices
We publish a list of new medical devices registered from 03.13.2026 to 03.20.2026
Link to the list: [see table in the attachment]
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