News Digest 04.07.2025 — 11.07.2025
Regulators
Roszdravnadzor may extend the experiment on labeling medical devices
The Public Council under Roszdravnadzor has come up with an initiative to extend the experiment on labeling medical devices, which is scheduled to end on August 31, 2025. The pilot project showed that some equipment and consumables did not meet the stated requirements, writes the Pharmaceutical Bulletin.
During the interim analysis, Roszdravnadzor found out that the packaging, as well as the equipment for printing and reading codes, did 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. In addition, discrepancies were identified between the data and terminology in the GS1 Russia and National Product Catalog systems.
Criteria for confirming Russian production will be established for diagnostic devices
The Ministry of Industry and Trade has developed criteria for assessing the origin of medical equipment - devices for functional diagnostic studies or for monitoring physiological parameters. The draft government resolution was published on July 9 on the regulation.gov.ru portal.
Amendments are proposed to the RF Government Resolution No. 719 of July 17, 2015. In total, the department has put forward more than 15 criteria that will help confirm that the goods are Russian. They take into account, in particular, the presence of research and development work and a scientific and production base in Russia, rights to software and the performance of a number of technological operations. Thus, the development, assembly, functionality testing and packaging of products, as well as loading and configuration of Russian-language software, must be carried out on the territory of the country.
A point system for confirming the Russian origin of complex devices has been in effect in Russia since September 2022. It was designed to stimulate the development of Russian localization, technological operations and components necessary for the development of the domestic industry.
Confiscated unmarked medical products will be donated to charity
The State Duma adopted in the third reading a draft federal law providing for the possibility of transferring to those in need free of charge, in the form of humanitarian aid, medicines and medical products (except for alcohol-containing ones), dietary supplements and other goods. The decision applies to products that specialized agencies confiscated by a court decision due to the lack of marking. The bill has been sent to the Federation Council for consideration, after which it must be signed by Russian President Vladimir Putin. If approved, the document will enter into force within 90 days from the date of its official publication.
The regulations were developed by the Russian Ministry of Industry and Trade with the aim of amending the Code of Administrative Offences to expand the range of goods that can be donated to charity. The explanatory note to the bill noted that the proposed changes are aimed at "creating legal certainty" for highly sought-after consumer goods in order to enable their further use by the state after confiscation and to prevent unmarked goods from being re-circulated illegally.
The developer of the draft Federal Law indicated that the possibility of donating such products to charity would correspond to the "social function of the state". According to current legislation, property can be donated free of charge for humanitarian response purposes at the request of the Russian Ministry of Defense and the Russian Ministry of Emergency Situations, as well as the All-Russian public movement "People's Front "For Russia". A mechanism for transferring confiscated goods to those in need for the light industry sector is also already in place.
The document approved by the State Duma states that after confiscation, goods from the list may not only be donated to charity, but also recycled or destroyed. The criteria by which products will be selected are not spelled out in the text of the draft Federal Law. It is planned that they will be established separately by the Government of the Russian Federation together with federal executive bodies and organizations designated by them.
Initially, the bill stated that goods that are found to be unsafe or unsuitable for use during the examination are subject to destruction, disposal and recycling. In this form, the State Duma adopted the document in the first reading in February 2025, but by the third reading, this wording was excluded.
Mandatory labeling of drugs has been in effect in Russia since July 1, 2020. The exception is new regions where such a system will be introduced ena from April 1, 2026. The operator through the Honest Sign system is Operator-CRPT. Some groups of medical devices and dietary supplements are also subject to labeling.
Market news
Skolkovo resident to supply Africa with limb prostheses worth 1 billion rubles
Skolkovo resident, manufacturer of bionic and pneumatic limb prostheses Steplife will supply the Republic of Sudan with components for leg and arm prostheses worth 1 billion rubles. The agreement between Steplife and the Team Care Sudan medical center network was signed in Cairo (Egypt). It is planned that both parties will jointly produce prostheses for delivery to the North African region. It is expected that at least 1,500 people in Sudan will be provided with prostheses.
Steplife plans to provide the North African region with the company's full flagship line: Steplife P5 pneumatic prostheses, Steplife B7 bionic prostheses, sports and everyday feet, components and repair kits.
"We have been preparing this deal for more than one month," says Steplife CEO Ivan Khudyakov. - Now the parties are ready to launch production cooperation. But first, our Sudanese colleagues will have to undergo serious systematic training in Steplife production and design standards in order to become part of the company's international ecosystem. I would also like to note that with this deal we continue to implement our business plan aimed at diversifying production. Thus, a number of our processes are localized not only in Russia, but also in other countries and regions, such as India, China, Brazil, Indonesia."
Source: https://sk.ru/news/rezident-skolkovo-postavit-v-afriku-protezov-konechnostej-na-1-mlrd-rublej/
Other
Muscovites will be able to record pulse and pressure in an electronic medical record using an AI assistant
Muscovites can now enter data about their blood pressure and pulse into an electronic medical record from any device where a virtual assistant based on artificial intelligence technologies (AI assistant) is installed. The new function is available in the mobile application "EMIAS. INFO", the press service of the mayor's office reported on July 7.
To access the electronic medical record, you need to log in to the application through your mos.ru portal account, then go to the "Health Diary" section and click the "Connect Alice" button. After that, you need to ask the AI assistant to launch the EMIAS skill and name your blood pressure and pulse rates.
The procedure takes no more than a minute. The doctor will be able to use this information as part of the clinical picture during an appointment.
By the end of August, the developers plan to add the ability to mark data on height, weight, as well as blood sugar levels and oxygen saturation to the service.
Earlier, Deputy Minister of Healthcare Tatyana Semenova urged doctors not to be afraid of AI assistants. According to her, artificial intelligence will help relieve doctors of routine work so that they can spend more time on their core work.
Before this, Deputy Minister of Healthcare Vadim Vankov said that more than 200 AI-based solutions are in the process of being created in organizations subordinate to the Ministry of Healthcare. More than half of them are aimed at helping doctors at the diagnostic stage. In addition, potentially with the help of medical products with AI it will be possible to solve more than 100 potential clinical problems, Vankov noted.
New registered medical devices
We publish a list of new medical devices registered from 07.04.2025 to 07.11.2025
Link to the list: [see table in the attachment]
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