News Digest 22.03.2024 — 25.03.2024
Regulators
The government approved the Regulations on the information system for monitoring northern deliveries
The Government of the Russian Federation approved the Regulations on the federal state information system for monitoring northern deliveries. The system will store data on deliveries and available supplies of goods, including medicines and medical products, and interaction with other government portals and departments will also be carried out through it. The novella will come into force on April 1, 2024 simultaneously with the framework law “On Northern Delivery”.
The resolution states that the created information system will have to ensure accounting and labeling of northern delivery cargo, monitoring their movement, assist in planning northern delivery, identify timely risks of supply disruptions and keep records of strategic stocks of goods.
Information in the system will be divided into three blocks - publicly available information about northern deliveries, personal account, statistics. The first subsystem will provide open access to regulations governing northern supplies. In the personal account it is planned to post information about the progress of deliveries expected by program participants, plan optimal logistics routes and quickly identify risks of failures. The “statistics” subsystem will provide tools for generating reports on specified indicators and characteristics.
The list of portals, communication between which will be carried out by the northern delivery monitoring information system, includes a unified information system in the field of procurement, a state information system for electronic transportation documents, an automated system for centralized preparation and registration of transportation documents of the Russian Railways, and others.
The framework law for the northern delivery program was signed by Russian President Vladimir Putin in August 2024. The document spells out a set of measures and financial mechanisms for the regular and uninterrupted supply of territories belonging to the regions of the Far North and similar territories with limited delivery times for goods.
In December 2023, the Russian Government approved a list of goods that will be delivered as a priority to the relevant areas. The list included 160 items from seven categories, including drugs from the Vital and Essential Drugs list, medical devices and specialized medical nutrition products.
The sale of medical devices that have not passed mandatory labeling will be limited from March 1, 2025
From March 1, 2025, the government will limit the sale of medical devices that are subject to mandatory labeling and are blacklisted or have not received labeling in real time. A ban on the sale of products that do not comply with the labeling rules not in real time (offline) will be established only for wheelchairs.
Amendments were made to the Decree of the Government of the Russian Federation No. 1944 of November 21, 2023, which establish restrictions on the sale of substandard labeled products.
In particular, for medical products, in case of sale with authorization in the tracking system of the real-time labeling system, the sale of medical devices with an expired expiration date, with a substandard code or its absence, as well as a product recalled by the manufacturer will be limited from March 1, 2025. In the case of non-real-time sales, the restriction from March 1, 2025 is established only on those products whose circulation is suspended by decision of the regulator - Roszdravnadzor.
In the case of the sale of wheelchairs, similar requirements are established to limit sales from March 1, 2025.
Mandatory labeling of medical devices has been consistently introduced since 2023, the operator of the system is “Operator-CRPT”. Monitoring is designed to prevent the illegal production and trafficking of medical products. From September 1, labeling became mandatory for wheelchairs, skin antiseptics and dietary supplements. On October 1, 2023, the rules came into force for air disinfectants and orthopedic shoes.
For hearing aids, coronary stents, CT scans, absorbent underwear and medical gloves, mandatory labeling has been introduced since March 1, 2024.
The list of medical products subject to labeling is constantly expanding. In October 2023, the Government of the Russian Federation approved an experiment on voluntary labeling of technical means of rehabilitation (TSR). The pilot project will start on October 15, 2023 and will last until the end of August 2024. In March 2024, the Ministry of Industry and Trade developed a new pilot project for labeling syringes, test tubes, medical masks, ventilators and neonatal equipment. It is assumed that the experiment will start on September 1, 2024.
Roszdravnadzor institutions will be able to receive subsidies to support the implementation of medical devices with AI
Roszdravnadzor has made changes to the Procedure for distributing subsidies to departments subordinate to the service, expanding the list of purposes for which subsidies can be spent. New tasks include classification of medical products, analysis and collection of statistics on the circulation of medical products, as well as methodological assistance with the introduction of medical products based on artificial intelligence (AI) technologies in the regions.
Amendments were made to Order No. 4027 dated May 11, 2021. The list of purposes for which a subsidy can be directed has been supplemented with four items. Among them are the formation and maintenance of a nomenclature classification of medical devices, analysis, monitoring, information and analytical support and data processing in the field of circulation of medical devices and other segments for which the department is responsible.
Two more areas for receiving subsidies are providing methodological support and coordination of the implementation of medical products based on artificial intelligence technologies in the regions and reports on their implementation, as well as the formation of a system of measures for the implementation of specialized medical devices during the “Healthcare” national project.
In February 2024, the Ministry of Health compiled recommendations for regions on the procurement of medical products with AI. The Regulations include recommendations for the acquisition and implementation of software with artificial intelligence technology related to medical devices that have passed state registration in the manner established by the Government of the Russian Federation, or have been registered in accordance with the laws of the EAEU.
With the support of the Russian Ministry of Health, in 2023, 106 medical products with artificial intelligence were introduced in 85 constituent entities of the Russian Federation. 368.8 million rubles from the federal budget and 79.5 million rubles from the regional budget were allocated for the purchase of such solutions. With the help of AI, 22 million records were analyzed, in six regions, voice-filling services for documents are used, and in 29, virtual assistants with AI are used to make appointments with a doctor. In 2024, three solutions based on artificial intelligence should work in practical healthcare in each region.
Market news
A new medical outpatient clinic opened in the village of Momotovo, Krasnoyarsk Territory
The Federal Service for Surveillance in Healthcare constantly monitors the implementation of the National Healthcare Project. According to the territorial body of Roszdravnadzor for the Krasnoyarsk Territory, a new medical outpatient clinic has opened in the village of Momotovo, Kazachinsky district, built as part of the primary care modernization program of the national Healthcare project.
The need for an outpatient clinic here has been long overdue: the population living on the territory of the Momotovsky village council is 444 people, of which 91 are children. But taking into account the nearby settlements (on the right bank of the Kazachinsky district), the population is 983 people, including 177 children. Communication with the regional center is carried out mainly by ferry and this is fraught with situations when settlements are cut off from Kazachinsky.
The new outpatient clinic in Momotovo is equipped to all standards: there is computer equipment, an apparatus for measuring eye pressure, an electrocardiograph, a defibrillator, express analyzers, and dental equipment.
Source: https://t.me/roszdravnadzor_official/2366
Other
The Medplant company has registered a portable electric aspirator
A resident of the Technopolis Moscow SEZ, the Medplant company, has registered a portable electric aspirator that can be used to provide emergency and resuscitation care. The device has been tested and has already been entered into the state register of medical devices.
Production of the first large batch of the device will be completed this month. The Whirlwind aspirator is used to sanitize the upper respiratory tract when a large amount of liquid or foreign body enters the body. It can operate either from an external network or the vehicle’s on-board network, or from an internal power source. Circuit solutions will allow you to increase the battery life of the device by up to 45 minutes due to the energy-saving mode.
The developers cite small dimensions and lightweight design as the main advantages of the aspirator. Weighing less than three kilograms, it has a capacity of 17 liters per minute. The company clarifies that the device has no analogues on the Russian market. Mass equipping of ambulances with aspirators is planned for the middle and end of 2024.
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