News Digest 10.04.2026 — 17.04.2026
Regulators
Requirements for Inspection of Medical Device Production in the Eurasian Economic Union (EAEU) Approved
The Eurasian Economic Commission (EEC) has approved new guidelines for inspecting medical device production. The document (available on MV) outlines what inspectors should monitor and how, from design and production to handling patient complaints and post-registration monitoring. The goal of these changes is to develop unified approaches to assessing the quality management systems (QMS) of manufacturers in the Eurasian Economic Union (EAEU) member states.
The guidelines introduce a unified approach to interpreting key concepts, including the definition of a "production site" as a geographically distinct complex uniting all facilities at a single address or group of addresses. Inspections are now 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 must collect. The recommendations also outline the priorities for selecting projects for inspection—from products with complaints and recent design changes to those that have not been under regulatory scrutiny for a long time.
The document stipulates that all checklists must be completed and signed by the inspection team leader, then attached to the report and stored by the inspection organization in accordance with internal regulations. Authorized bodies will be able to use these materials during inspections of the inspection organizations themselves, which increases transparency for both businesses and regulators.
The document places particular emphasis on the criteria for selecting representative projects for inspection, identifying critical suppliers, and the specifics of assessing individual processes, including risk management at all stages of the product lifecycle. When analyzing design processes, the manufacturer's implementation of safety requirements, consideration of general safety and performance requirements, and management of residual risks are assessed. According to the document, critical suppliers include organizations that supply medical devices or their main components to a medical device manufacturer, as well as suppliers of materials that come into contact with the human body as part of an implantable medical device.
Prostheses and test strips now fall under a point-based localization system
The Russian government has introduced a point-based system for determining the country of manufacture for a range of medical devices. The new regulations apply to complex prostheses, including hand assemblies, elbow and knee modules, as well as foot and hip modules, including bionic ones. Furthermore, the new localization regulations will now apply to breast implants, as well as consumables, such as urine and ostomy bags, glucose test strips, and dental wax.
Amendments were made to Government Resolution No. 719 of July 17, 2015, which defines the procedure for recognizing the country of manufacture of products. A total of 46 new items were added to the list.
The most significant changes to the regulations concerned the recognition of complex prostheses. Passive and active hand components made of polymers and synthetic rubbers (including those with microprocessor control), elbow, knee, and hip modules, as well as feet with both hydraulic and microprocessor control, are subject to point-based regulation. The minimum number of points for recognizing a product as Russian is set at 80 to 190, depending on the product type.
Points, according to the resolution, will be awarded based on the number of operations performed by the manufacturer within the EAEU, as well as for the use of domestic raw materials. Mandatory criteria will include the availability of technical documentation, and in some cases, a quality management system, registration certificates, and other documents.
One- and two-piece urine and ostomy bags, breast implants, glucose meter test strips, and dental consumables, including two types of dental wax, are also subject to country-of-origin point-based regulation. The Ministry of Industry and Trade has been gradually expanding the scope of medical devices covered by the points system, starting in late 2022. At the end of December, the Russian government approved a points system for determining the country of origin for 24 medical devices. The list was expanded over the course of two years, but not all proposals for adding medical devices were approved.
For example, at the end of 2025, the ministry proposed introducing a points system for an additional 94 types of medical devices, including dental devices (implants, filling materials, burs, and others), consumables (gloves, wipes, dressings, condoms, injection probes and needles, vacuum tubes, syringes, biomaterial containers, and angiographic catheters). These amendments were expected to come into force on January 1, 2026, but as of mid-April 2026, the amendments had not yet been adopted.
Source: https://vademec.ru/news/2026/04/13/protezy-i-test-poloski-popali-pod-ballnuyu-sistemu-lokalizatsii/
Market news
Japanese liquor giant announces acquisition of Daiichi Sankyo subsidiary
Demand for alcohol is falling in Japan, forcing major industry players to seek new revenue streams. To offset losses, leading spirits producer Suntory has decided to enter the over-the-counter (OTC) market.
Japanese spirits producer Suntory Holdings has agreed to acquire Daiichi Sankyo Healthcare, the over-the-counter (OTC) division of Japanese pharmaceutical corporation Daiichi Sankyo, for 246.5 billion yen (approximately $1.6 billion). This was announced in a press release.
Daiichi Sankyo's decision to sell the asset is driven by its strategy to refocus on developing innovative drugs, primarily anti-cancer drugs, according to Bloomberg. News of the agreement caused the company's share price on the Tokyo Stock Exchange to rise by more than 5%. This partially reversed the decline in its value, which had been almost 20% since January.
Suntory is the third-largest alcoholic beverage producer in the world. The group owns well-known brands such as Jim Beam and Maker's Mark. However, declining demand for alcohol in Japan, particularly among young people, has forced it to seek new sources of revenue. A similar path has already been taken by brewing giant Kirin Holdings, which acquired Australian dietary supplement maker Blackmores for $1.2 billion in 2023 and cosmetics brand Fancl for $1.4 billion a year later.
Other
The Russian Ministry of Health has amended the procedure for issuing sick leave certificates
The Russian Ministry of Health has approved a new procedure for issuing sick leave certificates (the order is available on MV). According to the document, parents can retain their right to benefits if they work for another insurer during parental leave, meaning they can combine maternity leave with part-time work at other organizations without risking being left without insurance coverage. Furthermore, self-employed citizens—individuals who use the special tax regime "Tax on Professional Income"—can also receive sick leave.
From 2026 to 2028, Russia will conduct a pilot program of voluntary social insurance against temporary disability (sick leave) for the self-employed. To participate, you must submit an application to the local office of the Pension and Social Insurance Fund of the Russian Federation via the "My Tax" mobile app, "Gosuslugi," or in person by September 30, 2027. The monthly insurance premium will be between 35,000 and 50,000 rubles. The monthly contribution will be 3.84% of this amount.
This right arises after six calendar months of contribution payments. During incapacity for work, confirmed by a sick leave certificate, contributions are not paid, and the insurance period is not interrupted. Previously, only individual entrepreneurs, notaries, and lawyers had this opportunity.
MV previously reported on other changes to the rules for issuing sick leave certificates. For example, doctors are now allowed to use the MAX messenger to remotely close sick leave certificates. Seventy percent of healthcare workers surveyed oppose the introduction of MAX messenger into the healthcare system. Moreover, more than half of respondents have already encountered management requirements to install and use the app.
Air Pollution Increased Migraine Attack Frequency
Scientists from Ben-Gurion University of the Negev have found a negative impact of air pollution on migraine attack frequency. The study's results were published on the American Academy of Neurology (AAN) website.
By analyzing air pollution levels and the frequency of hospital visits, the researchers found a link between the concentration of various pollutants in the air and the frequency of migraine attacks. It turned out that on the day when the highest number of patients sought help for migraines, pollutant levels were significantly higher than average. For example, the concentration of particulate matter with a diameter of 10 micrometers or less (PM10) was 119.9 μm/m³, compared to an average of 57.9 μm/m³. PM2.5 levels reached 27.3 µm/m³ (average 22.3 µm/m³). Nitrogen dioxide levels rose to 11.2 parts per billion (average 8.7 ppb).
On the day with the fewest visits to the clinic, pollution levels were, conversely, the lowest.
Analysis controlling for other factors, including gender and socioeconomic status, showed that short-term exposure to high nitrogen dioxide levels increased the likelihood of developing a migraine by 41%. Exposure to high levels of sunlight or ultraviolet light also increased the risk of migraine by 23%.
Air conditioning also played a role. Exposure to nitrogen dioxide was increased by high temperatures and low humidity, while cool air and high humidity exacerbated the effects of PM2.5.
Source: https://medvestnik.ru/content/news/zagryazneniya-vozduha-povyshali-chastotu-pristupov-migreni.html
New registered medical devices
We publish a list of new medical devices registered from 04.10.2026 to 04.17.2026
Link to the list: [see table in the attachment]
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