News Digest 14.08.2026 — 21.08.2026
Regulators
Medical Device Monitoring Checklists Updated
Roszdravnadzor has updated the checklist forms used to monitor the circulation of medical devices. Order No. 662 (available on MV) dated July 22, 2026, replaces the two previous orders—No. 1 dated January 10, 2022, and No. 5169 dated September 17, 2025—which are now considered invalid.
All seven checklist forms, covering key stages of the medical device lifecycle, have been updated:
- Technical testing and toxicology studies of medical devices;
- Clinical trials of medical devices;
- Use of medical devices in a healthcare facility;
- Circulation of medical devices by manufacturers and/or authorized representatives of the manufacturer;
- Maintenance, adjustment, installation, and repair of medical devices;
- Transportation of medical devices;
- Storage and/or sale of medical devices.
Furthermore, references to regulatory legal acts, such as orders of the Russian Ministry of Health and decisions of the Eurasian Economic Commission, have been updated in all forms. The wording of the clinical trials checklist has been clarified, and the structure and composition of the questions have been modified. For example, in the checklist for conducting technical tests and toxicology studies, the question "Have the inspected organization tested the medical devices for compliance with all requirements contained in the manufacturer's regulatory, technical, and operational documentation?" has been replaced by the question "Have the inspected organization documented the conformity assessment results of the medical devices on paper or as an electronic document?"
The checklist for compliance with mandatory requirements for clinical trials of medical devices now has 13 questions instead of 15. Specifically, the question about whether the medical organization maintains records of the devices being tested and the clinical trials being conducted in the form of a list of clinical trials has been removed from the appendix. The third checklist (compliance with mandatory requirements for the use of medical devices in a healthcare facility) now has 12 questions instead of 16, and the sixth and seventh (maintenance and transportation) now have six instead of seven.
Source: https://medvestnik.ru/content/news/obnovleny-chek-listy-dlya-kontrolya-za-medizdeliyami.html
The Russian Ministry of Industry and Trade has proposed introducing a zero VAT rate for certain Russian medical devices
The Russian Ministry of Industry and Trade has developed a bill introducing a zero VAT rate for Russian manufacturers of medical devices on a list to be approved by the Russian government. To qualify for this benefit, a registration certificate and an entry in the industrial product register will be required.
The Russian Ministry of Industry and Trade has developed a draft federal law proposing a zero VAT rate for certain medical devices not included in the list of tax-exempt devices. The document is being publicly discussed until August 31.
The proposed amendments are to Articles 164 and 165 of Part Two of the Russian Tax Code. The document provides for a 0% tax rate for Russian manufacturers of medical devices on a list to be approved by the Russian government. Exceptions will be medical devices that are fully exempt from VAT and those subject to a 10% rate.
If a medical device is included in the list for a 0% rate, it is exempt from the 10% rate. It is clarified that to apply the reduced rates, a registration certificate for the medical device (issued under EAEU law or Russian Federation law) or an extract from the state register of medical devices must be submitted to the tax authority.
A new clause 15.9 is added to Article 165 of the Tax Code of the Russian Federation, establishing the list of documents required by tax authorities:
- a registration certificate for the medical device or an extract from the state register of medical devices;
- an extract for the medical device from the register of Russian industrial products and/or the Eurasian register of industrial goods.
"Therefore, in addition to supporting Russian organizations manufacturing medical devices, the bill will also increase the level of localization of medical devices," the explanatory note to the document states.
The bill aims to expedite the adoption of state support measures for the development and production of medical devices.
The scoring system for localization of stents and catheters has been amended
The Russian government has approved a resolution amending the scoring system for assessing the country of origin for certain catheters and stents. The Ministry of Industry and Trade developed the initiative. The regulator noted that the changes are necessary to "further enhance the localization of medical device production in the Russian Federation and create additional incentives for the development and adoption of promising technologies."
The amendments were made to Government Resolution No. 719 of July 17, 2015, which defines the procedure for recognizing the country of origin of products. These amendments apply to medical devices classified under OKPD2 codes 32.50.22.195, 32.50.22.190, and 32.50.13.110. These are drug-eluting coronary artery stents, bare-metal coronary artery stents, and standard balloon catheters for angioplasty.
The document will come into force on January 1, 2027. The Ministry of Industry and Trade clarified that this deadline was set "to establish benchmarks for deepening localization, while also ensuring a smooth transition to country-of-origin verification through a points-based assessment system, taking into account manufacturers' efforts to include their products in the register of Russian industrial products."
Market news
AI and robotic surgery will accelerate growth in the cardiovascular device market
The global cardiovascular device market was valued at $62.05 billion in 2025. According to Polaris Market Research, it is expected to reach $67.22 billion by 2026 and reach $128.73 billion by 2034, with a CAGR of 8.4%. Market expansion is driven by the rising prevalence of cardiovascular diseases, an aging population, increasing obesity, sedentary lifestyles, and unbalanced diets. Public investment in medical infrastructure and the development of minimally invasive technologies are driving additional demand.
Cardiovascular devices are used for the diagnosis, treatment, and long-term management of heart and vascular diseases. These include pacemakers, defibrillators, stents, catheters, and artificial valves. In 2025, surgical devices were the largest market segment, accounting for 56% of revenue. Analysts attribute this to the growing number of complex interventions, including coronary artery bypass grafting and valve replacement. Demand is also supported by the development of catheter technologies, robotic surgical platforms, and new implants.
Manufacturers are striving to reduce the invasiveness of procedures, improve the precision of interventions, and shorten patient recovery times. Artificial intelligence is becoming a key driver of market growth. Machine learning algorithms analyze ECGs, images, and patient data to help identify arrhythmias, ischemia, and signs of heart failure.
AI-based surgical assistance systems also improve the accuracy of minimally invasive cardiac procedures. AI is also being used in remote monitoring systems. Wearable and implantable devices can continuously collect cardiac activity data and transmit it to medical specialists for timely decision-making.
Another emerging area is robotic systems used in minimally invasive cardiac surgeries and catheter-based interventions. They help improve the precision of procedures, reduce incision size, and shorten recovery time. Other technological trends include lead-free pacemakers, bioresorbable stents, and 3D visualization.
Key market players include Medtronic, Boston Scientific, Abbott Laboratories, Edwards Lifesciences, B. Braun Melsungen, Biotronik, Cook Medical, Terumo, MicroPort Scientific, Meril Life Sciences, and others. The main barriers for manufacturers remain strict regulatory requirements, high equipment costs, and lengthy processes for bringing new devices to market.
The global robotic prosthetic limb market could reach $4.15 billion by 2034
The global robotic prosthetic limb market was valued at $1.41 billion in 2025, is expected to reach $1.58 billion by 2026, and could reach $4.15 billion by 2034, with a compound annual growth rate of 12.9%, according to a report by Fortune Business Insights. The study examines the market by product type, technology, patient age, end user, and region.
The main market drivers remain complications of diabetes, peripheral vascular disease, trauma, cancer, and age-related changes. Its expansion is constrained by the high cost of devices, limited insurance coverage, a shortage of qualified prosthetists, and the complexity of long-term maintenance.
Robotic prosthetic limbs integrate sensors, microprocessors, motors, batteries, software, and control systems. These devices are designed to restore mobility, balance, prehension, and independence to people with amputations. Lower-limb prosthetics remained the largest market segment in 2025. This includes robotic knee, ankle, and foot prosthetics, as well as other gait rehabilitation devices. This segment's leadership is due to the fact that lower-limb amputations are significantly more common than arm amputations.
The upper-limb prosthetics segment, on the other hand, will grow faster than the overall market. Its CAGR from 2026 to 2034 is projected to be 14%. This category includes robotic arm, hand, and other devices. Developers are focused on creating multifunctional bionic hands capable of recognizing movements, providing various grip options, and transmitting contact information to the user.
The report also provides a separate regional analysis. The US market could reach $760 million in 2026, or approximately 48.4% of the global market. Europe will remain the second-largest regional market, with a projected CAGR of 11.6% and a potential market volume of $430 million in 2026. The region's largest markets will be Germany, the UK, France, Italy, and Spain. The Asia-Pacific region could take third place with a market volume of approximately $310 million in 2026.
Earlier, MV reported that the Russian government will allocate 360 million rubles from its reserve fund to establish three centers for prosthetic and orthopedic care and rehabilitation. The funds will be allocated by the Russian Ministry of Labor as a subsidy to the Rostec Center for Innovative Technologies in Orthopedics (JSC CITO). New prosthetic centers are expected to open by the end of 2026 in Nizhny Novgorod, Krasnoyarsk, and Yalta at facilities under the jurisdiction of the Federal Medical and Biological Agency (FMBA) of Russia.
Other
Scientists Achieve Hypoallergenic Peanuts with Gene Editing
U.S.-based Nurtured Nuts Co., in collaboration with Israeli biotech company BetterSeeds, used CRISPR gene editing technology to create a peanut devoid of three key proteins that trigger anaphylactic shock in people with allergies. This development will allow the product to be reintroduced to areas where its consumption has been restricted due to health risks, such as schools, hospitals, and airlines. The company expects to begin shipping samples to potential customers after the first harvest in September 2026, with full sales expected in 2027.
Using a gene editing technique that selectively disables specific genes (CRISPR), the manufacturer removed the RH2, RH6, and RH7 proteins. After successful lab growth, the plant was planted outdoors, making it "the first commercially available, field-grown, industrial-scale, gene-edited peanut product," according to the Institute of Food Technologists (IFT). In early August 2026, the project won a grant competition from the institute and received $10,000 for development.
The company expects the first harvest in September 2026, and processing in October, after which it will begin providing samples to potential customers. Full sales are planned for 2027, and an investment round will begin in September of this year. The company plans to produce not only shelled nuts and peanut butter (in various packaging, from individual cups to industrial containers), but also peanut butter and flour. Its long-term strategy is to become an ingredient supplier to major consumer goods manufacturers, including peanut-filled chocolates.
According to company representatives, the initial distribution channels will be educational institutions, hospitals, and airlines, where peanuts have long been banned from the menu. Nurtured Nuts also recognizes the need for extensive outreach to parents and educational institutions to convince them of the safety of the new product.
The manufacturer of the Multikan-8 dog vaccine suspects destructive interference by third parties
Vetbiokhim, the manufacturer of the Multikan-8 dog vaccine, has reported possible destructive interference by third parties in the deaths of animals after vaccination in the Yaroslavl region.
The company added that as of August 19, batch 20 of the vaccine had been recalled.
Company specialists are conducting a series of scientific research activities in the Yaroslavl region. A re-quality check of batch 20 of the vaccine, as well as the production conditions, is currently underway. Furthermore, archived vaccine samples have been sent to a state-accredited body for independent examination. Rosselkhoznadzor told TASS that it would contact the prosecutor's office to conduct a joint inspection of the Multikan-8 production facility. However, Rosselkhoznadzor has not received any official complaints from citizens regarding adverse reactions in pets following the use of this vaccine.
Earlier, it was reported that the Yaroslavl Veterinary Center suspended the use of Multikan-8 following reports of complications in animals.
New registered medical devices
We publish a list of new medical devices registered from 08.14.2026 to 08.21.2026
Link to the list: [see table in the attachment]
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