News Digest 08.08.2025 — 15.08.2025
Regulators
Experience on labeling medical devices extended until 2026
The government has extended the experiment on labeling certain medical devices — masks, syringes, infusion systems, and equipment for therapy and breathing — until February 28, 2026. The pilot was planned to be completed in August. Now, the regulators responsible will have to evaluate its results and submit a report to the government by January 31, 2026.
In 2024, the Ministry of Industry and Trade proposed to include a new group of goods in the labeling pilot launched in 2022, including syringes, test tubes, napkins, and other consumables. In July of this year, the Public Council under Roszdravnadzor came up with an initiative to extend the experiment. Experts said that the packaging, as well as the equipment for printing and reading codes, do not meet the established requirements. This does not guarantee the safety and readability of the labeling for five years, as required by law. Manufacturers and importers face difficulties when working with group packaging, and the implementation of the necessary functionality in the system of the Center for the Development of Advanced Technologies (CRPT) requires additional time, the Public Council noted. In addition, discrepancies were identified between the data and terminology in the GS1 Russia and National Product Catalog systems.
Experts also stated the need to extend the experiment until all participants in the process reach the required level of technical and organizational readiness.
Source: https://medvestnik.ru/content/news/Eksperiment-po-markirovke-medizdelii-prodlili-do-2026-goda.html
The list of medical devices for palliative care at home has been updated
The Ministry of Health has updated the list of medical devices (MD) designed to support the functions of organs and systems of the human body in the provision of palliative care for use at home. The Ministry of Justice registered order No. 398n dated July 9, 2025 (available on "MV") on August 13.
The updated list includes seven groups of medical products. Five of them were in the previous version of the document: anesthetic and respiratory medical products, auxiliary and general hospital medical products, gastroenterological products, medical products for manipulation/restoration of human tissues and organs, rehabilitation and adapted for disabled people. In addition, groups of cardiovascular and urological medical products appeared.
At the same time, the number of items in the updated list was reduced from 235 to 170. For example, in the column "Adapted household products" there were 10 items, including a set and pump for enteral nutrition, an aspiration system, and a toilet seat. In the new list, only one item remains in this column - a syringe for administering drugs orally/enterally. Some items have been replaced: for example, a diagnostic spirometer has been included instead of a peak flow meter as a respiratory function analyzer. A breathing circuit bag and a breathing circuit sensor have been added to the list.
The list for simplified registration of medical devices includes stretchers and gurneys
For the first time in 2025, the Interdepartmental Commission has expanded the list of medical devices for simplified registration in accordance with RF Government Resolution No. 552 of April 1, 2022. The list includes six more items related to stretchers and gurneys, including those for emergency medical care. In the current version, the list contains 2,216 items.
The list was expanded following the results of the commission meeting held on July 24, 2025. New positions of the document are portable stretchers, manual, electro-hydraulic and pneumatic stretchers for emergency medical care, as well as two types of adaptive stretchers - recumbent and wheeled.
The Russian government introduced a simplified procedure for registering medical devices in April 2022 (PP No. 552) until September 1, 2023 with the option of obtaining an indefinite dossier and simplified the procedure for replacing raw materials and components in registered medical equipment. In September 2022, the simplified registration regime was extended until January 1, 2025. It became possible to register low-risk medical devices, with the exception of sterile ones, by notification - subject to the provision of the product for testing within five working days to an institute subordinate to Roszdravnadzor and the submission of a package of documents within 150 days. At the end of May 2022, Roszdravnadzor approved Order No. 4282 on the regulations for the work of a special interdepartmental commission determining the list of products for accelerated registration. The list includes items with a risk of shortage on the Russian market or in connection with an application from an authorized person for the supply of medical products at a price below the average market price, based on the prices of contracts concluded after March 1, 2022. "Other medical products" are included in the list only in the event of a unanimous decision of the commission. In June of the same year, 37 codes of reagents and laboratory equipment for in vitro diagnostics were included in the list. Three weeks later, the н was expanded by more than 1.5 thousand codes. About half of the list consisted of reagents for in vitro diagnostics, as well as laboratory equipment and specialized consumables. In addition to them, the list included dental equipment (lamps, scanners, X-ray systems) and consumables, equipment for anesthesiology and resuscitation, including artificial lung ventilation devices, consumables for interventional surgery, including implantable ones (stents and catheters), cardiac monitors. The list was actively expanding during 2023, when it grew to 1.8 thousand items, but in 2024 the process began to slow down. As a result, for the entire 2024, it was replenished three times: in March 2024, it included external knee, ankle and hip joint prostheses, hearing aids, hemostatic agents, tourniquets, lower and upper limb orthoses and walkers. In total, the list has grown from 1,945 items to 2,206 items. In July, two more items were added to it - an outpatient insulin injection kit and a tissue expander for a skin port. In December 2024, an upper limb exoskeleton and a single-channel IVD biochemical analyzer for use near the patient were added to the list. As of the beginning of 2025, the list contained 2,210 items.
Market news
Serial production of components for glucometers launched in Tula region
Serial production of plastic and silicone components for test strips and glucometers designed to monitor blood glucose levels in patients with diabetes has been launched in Aleksin, Tula region. The projects are being implemented by the Nova Innovative Enterprise company with the support of the Industrial Development Fund (IDF), which provided 179 million rubles in a preferential loan out of a total investment of 268 million rubles, the fund's press service told MV.
The enterprise plans to produce up to 658 thousand sets of parts for glucose monitoring systems and up to 4.8 million sets of test strips per year. The main customer will be the Irkutsk company MedTechService, which previously purchased similar products abroad, including in China and Thailand. Production in Aleksin will completely replace imports in the segment of plastic and silicone parts of glucometers and provide Russian manufacturers with stable supplies, the FRP said.
The CEO of Bryansk's Ekstramed was accused of fraud worth 28 million rubles in the supply of ventilators
On August 12, the Sovetsky District Court of Bryansk remanded in custody until October 10, 2025, the CEO of Ekstramed LLC, accused under Part 4 of Article 159 of the Criminal Code of the Russian Federation (fraud committed on an especially large scale). According to investigators, the head of the company, while fulfilling a state contract to supply ventilators for newborns to the Bryansk Regional Children's Hospital for more than 28.3 million rubles, "acting for the selfish purposes of illegal enrichment," involved third parties. As a result, according to the Ministry of Internal Affairs, the hospital purchased medical equipment that did not meet the stated requirements and was unsuitable for further use.
Other
Apple unveiled an updated blood oxygen measurement feature for Apple Watch
On August 14, Apple announced that it would add a blood oxygen measurement feature to some of its watch models via a software update after receiving approval from the U.S. Customs Service amid a protracted legal dispute over the technology.
The feature will be available to some Apple Watch Series 9, Series 10, and Apple Watch Ultra 2 users. They will need to update their paired iPhone to iOS 18.6.1 and their Apple Watch to watchOS 11.6.1. After this update, sensor data from the Blood Oxygen app on Apple Watch will be transferred to the paired iPhone, and the results will be available in the Breath section of the Health app.
The updates will not affect Apple Watch devices that include the original blood oxygen feature, or Apple Watch devices purchased outside the United States.
According to Reuters, the company managed to get approval from the U.S. Customs Service after a lengthy legal battle with Masimo, which accused Apple of hiring its employees and stealing its pulse oximetry technology after discussing a potential partnership. The companies have been in court since 2020.
Masimo initially won a ruling from the U.S. International Trade Commission to bar watches with the feature, forcing Apple to remove the feature. This decision was made because the development violates patents owned by Masimo. Now, the US Customs has shaved the software update. There is no publicly available information about the progress of the legal dispute.
Source: https://t.me/vademecum_live/18795
New registered medical devices
We publish a list of new medical devices registered from 08.08.2025 to 08.15.2025
Link to the list: [see table in the attachment]
News
