News Digest 11.06.2026 — 19.06.2026
Regulators
Roskachestvo has identified issues with the registration and accuracy of blood pressure monitors
Roskachestvo tested 20 models of automatic blood pressure monitors available on marketplaces and in online pharmacies and found that more than half of them were sold without registration certificates from Roszdravnadzor. The study covered devices priced between 517 and 4,650 rubles, primarily manufactured in China. Experts assessed the devices based on 29 criteria, including measurement accuracy, compliance with labeling requirements, and the presence of mandatory documentation.
Of the 20 models tested, only eight brands had their registration certificates confirmed: Omron, B.Well, AND, Medcare, Microlife, Nissei, SberZdorovye, and Armed. All of them successfully passed the accuracy test and met the permissible measurement error. However, 12 brands lacked the necessary documentation, despite their products being marketed as blood pressure monitors.
Separately, experts identified three devices that did not meet their stated technical specifications. The Chinese-made Morenna, Market, and Arm Electronic models demonstrated measurement errors above the permissible limit of ±3 mmHg, which, according to Roskachestvo, could lead to errors in diagnosing hypertension and assessing a patient's condition.
The study also showed that a device's high price is not always associated with its accuracy. For example, the budget-friendly ARM STYLE tonometer, priced at 740 rubles, demonstrated results comparable to one of the most expensive models in the sample. However, in the segment up to 1,000 rubles, all tested devices lacked registration certificates. In the 1,000 to 2,500 ruble price range, two-thirds of the models had the necessary documents, and among devices priced over 2,500 rubles, all devices were registered.
Following the inspection, Roskachestvo submitted the materials to the regulatory authorities. The Moscow Office of Rospotrebnadzor (Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing) has already demanded that the Ozon marketplace take measures to stop sales of the Morenna blood pressure monitor by one of its sellers and issued a warning. Furthermore, product listings with identified discrepancies have been hidden on Ozon and Wildberries. Roskachestvo's complaints regarding the sale of blood pressure monitors without registration certificates are under review by Roszdravnadzor and the Russian Ministry of Health.
The organization also reminded that, starting September 1, 2026, individual product registration in the Honest Sign labeling system will be mandatory for medical devices, and the sale of products without the required labeling will be prohibited.
The Russian Ministry of Health has developed new instructions on how to handle citizen appeals
The Russian Ministry of Health has drafted new instructions on how the agency will handle citizen appeals. This document will replace Order No. 493n of July 28, 2015.
The instructions will include more ways to submit appeals to the Russian Ministry of Health. In addition to written or oral forms at an in-person meeting, mail, telegraph, and fax, appeals can now be submitted through government services. Previously, this was only possible through a special form on the ministry's official website.
One important change is that videoconferencing can now be used during in-person appointments.
The reasons why the agency may not respond to a citizen have been clarified. For example, if the text of a written request is illegible or does not allow one to determine the essence of the proposal, statement, or complaint. A clause has been added stating that citizens whose questions are answered on the ministry's official website are provided with the official website's email address within seven days, and the request is not returned.
The procedure for responding to requests has also been changed: they are now sent electronically to an email address, electronically to an official, or to the citizen's personal account on the Unified State Services Portal.
Revenue threshold for transition to VAT will be frozen until 2029
Bill No. 1256655-8 has been submitted to the State Duma of the Russian Federation. It proposes setting the revenue threshold for small businesses on the simplified tax system (STS) at 20 million rubles until 2029. The amendments are intended to be made to Article 145, Part Two of the Tax Code of the Russian Federation.
In 2025, the threshold was set at 60 million rubles per year to combat fragmentation. Starting in 2026, it was reduced to 20 million rubles. Now, businesses must pay VAT if they exceed this amount. The limit is to be reduced to 15 million rubles starting in 2027 and to 10 million rubles starting in 2028. The bill proposes shifting these deadlines:
- 20 million rubles for 2026-2029;
- 15 million rubles for 2030;
- 10 million rubles for 2031.
At the same time, as Forbes noted, the new bill extends the threshold freeze exclusively to businesses operating under the simplified tax system. For those operating under the patent tax system, everything remains the same: in 2027, the threshold is to be reduced to 15 million rubles, and in 2028, to 10 million rubles.
The explanatory note to the document states that the deferment "is aimed at providing genuine support to small businesses, will contribute to maintaining employment, and will create a more predictable business environment, taking into account the maximum possible certainty and stability of tax conditions in the medium term in the current economic and geopolitical situation."
Market news
The court refused to suspend the FAS order for the purchase of 34 CT scanners worth 867 million rubles
The Moscow Arbitration Court denied the St. Petersburg State Procurement Committee's request for interim measures in a dispute with the Federal Antimonopoly Service (FAS). The committee requested a temporary suspension of the FAS order issued following the review of a complaint regarding the purchase of 34 whole-body computed tomography (CT) systems worth a total of 867 million rubles. The equipment was intended for medical organizations in more than 20 regions of the country.
The recipients of the equipment included medical organizations in St. Petersburg, the Arkhangelsk, Murmansk, and Pskov regions, the Republic of Karelia, the Nenets Autonomous Okrug, and several other constituent entities of the Russian Federation.
The procurement was announced in May 2026 under the federal project "Modernization of Primary Healthcare." Four bids were submitted for the electronic auction, but after review, only one was found compliant. As a result, the procedure was declared invalid, and the only eligible bidder was effectively declared the winner.
The FAS's intervention followed a complaint from Intelmed JSC. The company claimed that the procurement commission had unreasonably accepted the winning bid despite containing false information about the characteristics of the proposed equipment. During the inspection, the antimonopoly authority reviewed registration certificates, technical documentation, and explanations from the CT scanner manufacturers.
The FAS found most of the disputed characteristics to be confirmed. However, for one indicator—the cooling rate of the X-ray tube anode—no supporting information was found in the registration documentation for the Malakhit-M CT scanner. A representative of the equipment manufacturer also confirmed the absence of this characteristic from the product's registration dossier.
Following its review of the complaint, the FAS ordered the cancellation of the procurement protocols, a new auction date, and a reconsideration of the bids. Until this order is complied with, contract conclusion is prohibited. Furthermore, the electronic trading platform operator must resume the bidding process from the last price achieved.
Challenging the antimonopoly authority's decision, the St. Petersburg State Procurement Committee argued that compliance with the order could delay the delivery of socially significant diagnostic equipment and negatively impact the implementation of the primary healthcare modernization program. However, the court found these arguments insufficiently substantiated and denied the application of interim measures. The main dispute over the legality of the FAS decision and order is ongoing.
A full-body CT scanner is coming to the US
The American AI startup Midjourney, a developer of neural networks for image generation and processing, announced its upcoming entry into the medical device market. The company is developing an ultrasound scanner capable of rapidly performing full-body scans, which will "reimagine the fundamentals of healthcare and the relationship we have with our bodies."
The procedure will involve diving into a pool, where the body passes through a ring of underwater sensors, each of which emits ultrasound waves and acts as an echo sounder. The resulting data is then transmitted to a massive cluster, where computers combine it into a 3D map of the body with submillimeter accuracy.
The developers' goal is to speed up the procedure, taking no more than 60 seconds. The company expects this type of medical imaging to become "not just commonplace, but literally every day."
In November 2025, Midjourney signed a joint development and technology licensing agreement with digital health company Butterfly Network, a manufacturer of portable ultrasound medical devices. The ultrasound scanner is expected to hit the market in late 2027. By 2031, approximately 50,000 such devices are planned to be produced, capable of performing approximately 1 billion full-body scans monthly.
Global AI services are actively integrating into healthcare. For example, OpenAI, the developer of ChatGPT, has introduced products for healthcare and individual patients: ChatGPT Healthcare and ChatGPT Health, respectively, according to MV.
Source: https://medvestnik.ru/content/news/v-ssha-poyavitsya-tomograf-dlya-skanirovaniya-vsego-tela.html
Other
Moscow Launches Pilot of New Stroke and Heart Attack Care System
The Moscow Department of Health (DZM) has launched a pilot testing of new approaches to managing adult patients with acute circulatory diseases—ischemic acute cerebrovascular accident (ACE) and acute myocardial infarction (AMI). The pilot began on June 15, 2026, and aims to reduce disability and mortality, as well as prevent complications associated with carotid bifurcation stenosis of the brachiocephalic arteries (BCA).
As part of the pilot, emergency medical service (EMS) personnel are required to record the onset time of clinical symptoms of ACE and AMI in a special field on the patient's call record. This time is determined exclusively by the medical professional of the responding team at the A.S. Puchkov Emergency and Urgent Medical Care Station. Altering the time of onset of clinical symptoms is prohibited at all stages of care. If the patient is unable to independently report the time of symptom onset, the emergency medical service provider must make every effort in accordance with the proactive investigation procedure for stroke.
The document separately specifies routing to the "Stroke" and "Infarction" networks.
It also mandates the creation of an expert analytical center for the management of patients with brachiocephalic artery stenosis and the assessment of indications for carotid revascularization at the S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, as well as an expert analytical center for the diagnosis and treatment of patients with circulatory diseases at the I.V. Davydovsky City Clinical Hospital.
UAE Establishes Regulator for Longevity Sector Development
The Prime Minister of the UAE and Ruler of the Emirate of Dubai, Mohammed bin Rashid Al Maktoum, has established the Dubai Longevity Authority (DLA), a government agency tasked with developing the territory as a global hub for longevity, wellness, and advanced medicine, as well as attracting investment in this area.
The creation of the DLA is aimed at strengthening Dubai's position among global leaders in quality of life and healthy life expectancy. The authority will develop and implement a scientifically sound regulatory framework for longevity therapies and innovations, license, and oversee the entire value chain: research and development, clinical trials, manufacturing, delivery, and clinical practice.
Most developed countries are deliberately focusing on longevity, shifting their focus from simply increasing life expectancy to increasing healthy life expectancy. Japan, Hong Kong, and South Korea are leading the way, with the average life expectancy exceeding 84–85 years. In Russia, at the end of May, the Russian Ministry of Health approved an order introducing a new medical specialty, "Healthy Longevity Doctor."
New registered medical devices
We publish a list of new medical devices registered from 06.11.2026 to 06.19.2026
Link to the list: [see table in the attachment]
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