News Digest 04.03.2024 — 07.03.2024
Regulators
Notifications of the start of activities related to the circulation of medical devices must be submitted to each new address
Entrepreneurs will be required to submit notifications of the start of certain types of activities, including the circulation of medical devices, to each new address. Corresponding changes to the rules for sending this information were made by Decree of the Government of the Russian Federation No. 219 dated February 28, 2024.
The option of submitting notifications through the public services portal or similar regional portals of state and municipal services has also been added. The applicant must indicate the name and address of the place of activity in the electronic notification card. The day the document is submitted is considered the day the applicant fills out and signs the papers.
Records of submitted notifications will be kept in a unified register of notifications. It will operate on the platform of a unified register of types of control.
The resolution comes into force on May 29, 2024.
Lawmakers intend to prohibit unscrupulous suppliers from participating in procurement
The Legislative Assembly of the Kaliningrad Region submitted to the State Duma a bill amending 44-FZ “On the contract system in the field of procurement of goods, works, services to meet state and municipal needs,” which would establish the obligation of customers to enter into contracts only with those participants whose information is not available in Register of Unscrupulous Suppliers (RNP). The authors of the initiative believe that this will help protect the rights of customers and increase the responsibility of contract executors.
Changes are proposed to be made to Part 1.1 of Art. 31, excluding words related to the customer’s right to establish or not establish a requirement to confirm the integrity of suppliers, and obliging the customer, when making purchases, to establish a requirement that there is no information about the procurement participant in the RNP.
At the moment, the only exception when customers are required to request such information from contractors is if the counterparty was included in the RNP due to refusal to fulfill a contract with a customer who was subject to foreign sanctions.
The inclusion of companies in the RNP often becomes the subject of litigation. Thus, in July 2023, the MAKS insurance company managed in the Moscow Arbitration Court to challenge the FAS decision to include the organization in the register after a complaint from one of the Rostec Group companies about the poor quality of VHI services. IC "MAX" stated that for their part they did not violate the terms of the contract, and the dispute was led, among other things, by the client's dissatisfaction with the refusal to pay for services that the insurance did not actually cover.
Struggles against inclusion in RNP and NIPK "Electron". In September 2023, the company appealed to the Moscow Arbitration Court the decision of the FAS to include the company in the register of unscrupulous suppliers. The reason was a complaint from the State Autonomous Institution “Gormedtekhnika” of the capital’s Department of Health for the X-ray complex “KRD-Expert”, delivered in May 2021 under a life cycle contract. The company demanded to suspend the regulator's decision by introducing interim measures, but the court refused to the plaintiffs.
Market news
In Nizhny Novgorod they plan to build two clinics for 1.4 billion rubles
The ordering center of the Nizhny Novgorod region has published auctions for the construction of two medical institutions in the capital of the region - adult and children's clinics - for 500 visits per shift each. The initial maximum contract price for the construction of an adult clinic is 703 million rubles, and a children’s clinic is 662 million rubles. The funds will be allocated from the targeted investment program of the Nizhny Novgorod region for 2024–2026.
The winner of one of the contracts must build a four-story building with a basement with a total area of 6 thousand square meters in the Sovetsky district of Nizhny Novgorod. m, which will house adult clinic No. 30. At the moment, there is no information about the departments planned in the institution.
The design documentation indicates that children's clinic No. 17 should be located in the Sormovsky district of Nizhny Novgorod in a four-story building with a basement with a total area of 6.8 thousand square meters. m.
The clinic plans to organize an emergency medical care center, departments for healthy children and infants, pediatric and surgical, rehabilitation, as well as a diagnostic unit with ultrasound, ECG, X-ray rooms and a laboratory.
The results of determining contractors for both competitions will be announced on March 14, 2024. The projects also have the same deadlines: all work must be completed no later than November 15, 2025.
In 2019, in another region - the Perm Territory - it was reported that the construction of three children's clinics had begun under a similar targeted investment program. A total of 950 million rubles were then allocated for the construction of institutions, including 123.5 million from the federal budget.
A contractor was found for the construction of a clinic in Balashikha for 36 billion rubles
The contract for the construction of a multidisciplinary clinic on the basis of the Balashikha Hospital in the Moscow Region was concluded on November 28 with the company “Monolithic Construction Management-1” (MSU-1), associated with the Federal Grid Company. The company became the only participant in the auction. The cost of constructing a medical facility with a total area of at least 108.3 thousand square meters. m will amount to 36.27 billion rubles. All work under the contract must be completed by February 2028.
The competition to determine the contractor was held on November 28, but it was declared invalid since only one application was submitted. According to the terms of the competition, the customer - the Directorate of the Customer for Capital Construction of the Moscow Region - had the right to conclude a contract with such a bidder.
According to SPARK-Interfax, Monolithic Construction Management-1 JSC was registered in 1999 in Lyubertsy, Moscow Region. The main beneficiary is JSC Gusfur (80%), another 20% belongs to LLC Stroyengineering. There is no revenue data for 2022. In 2021, the company earned 56.2 billion rubles, net profit amounted to 174.7 million rubles.
The tender for finding a contractor for the construction of a medical facility was published at the end of October 2023. According to the technical specifications, the contractor needs to build a building designed for 1,135 beds and 200 visits per shift in the emergency department and 600 visits in the clinical diagnostic center.
The building of the multidisciplinary clinic will consist of two buildings - the main one and the pathological anatomical one, which will be connected by an underground passage. An underground parking lot for 680 cars, five checkpoints, as well as technical buildings and structures will also be built at the medical facility.
The project stipulates that the main building will be ten stories high. On each floor there will be medical departments for various profiles, as well as an ambulance box, laboratories, and blood collection and transfusion stations. The medical and technological assignment states that the clinic is being created to improve the quality of medical care, assist in the development of drugs, medical technologies and medical products, as well as to develop educational activities and conduct scientific research in the field of health care based on world practices.
At the moment, the Balashikha Regional Hospital has 19 departments and 1,362 beds (with a standard requirement of 3,058 beds). They intend to eliminate the shortage of places through the construction of a multidisciplinary center. Initially, the governor of the Moscow region, Andrei Vorobyov, noted that they intend to allocate 50 billion rubles for the construction of the clinic.
Employees of the Moscow Region Social Insurance Fund were accused of inflating the prices of prosthetics for the disabled
The Department of the RF Investigative Committee for the Moscow Region has completed a criminal investigation against the general director of an unnamed company and the deputy head of the social programs department of the region's Social Insurance Fund. They are accused of fraud on an especially large scale (Part 4 of Article 159 of the Criminal Code of the Russian Federation).
According to investigators, the defendants, by prior conspiracy, entered into a commercial agreement and then inflated the initial cost of government contracts for the manufacture of prosthetics. In total, six contracts were concluded for a total amount of more than 43 million rubles.
The examination determined that the difference between the market value of the prostheses and the concluded contracts amounted to 4.8 million rubles. The accused, the Investigative Committee is convinced, embezzled these funds. The criminal case with the approved indictment has been sent to court for consideration.
Source: https://sledcom.ru/
Thanks to the National Healthcare Project, more than a thousand units of new medical equipment have been supplied to the Republic of Karelia
The implementation of the national project “Healthcare” is under special control of the Federal Service for Surveillance in Healthcare.
According to the Territorial Authority of Roszdravnadzor for the Republic of Karelia, thanks to the presidential project “Healthcare”, since 2019, 1067 units of new equipment have been purchased for medical organizations in the region: spiral computed tomographs, magnetic resonance imaging, modern endoscopic, ultrasound, laboratory and much other equipment.
Thanks to the measures taken, diagnostics are becoming more accessible to the population of the Republic. In particular, the number of ultrasound examinations increased by 17.5% from 2019 to 2023.
Source: https://t.me/roszdravnadzor_official/2333
Other
Clinics from nine regions applied to connect to the Moscow platform with medical AI services
Moscow has been given access to a special platform with artificial intelligence (AI) services for medical organizations throughout the country. At the moment, applications for connection to it have been sent from nine different regions of Russia, including the Republic of Bashkortostan and the Moscow region. Using the platform, doctors will be able to receive results from automatic analysis of radiation studies performed by smart algorithms. This was reported by Anastasia Rakova, Deputy Mayor of Moscow for Social Development.
Access to the mosmedia.rf platform (“MosMedII”) has been open since February 15. To date, applications have been received from medical organizations in St. Petersburg, the Moscow, Penza and Kemerovo regions, the republics of Bashkortostan, Dagestan, the Chechen Republic, the Krasnoyarsk Territory and the Yamalo-Nenets Autonomous Okrug.
On the platform you can familiarize yourself with the available services, operating rules and technical requirements for connection. It was developed by the Center for Diagnostics and Telemedicine of the Moscow Department of Health.
Source: https://www.mos.ru/news/item/136031073/
Amazfit has developed a smart mat for health tracking
The Body Composition Mat device collects detailed body composition data using bioelectrical impedance analysis technology. It can measure eight key health indicators - body fat percentage, muscle and bone mass, body index, skeletal muscle health, water content, protein levels and basal metabolic rate.
The user only needs to stand for some time on the electrodes, which create safe electrical impulses. The developer warns that the device is not intended for full medical diagnosis or treatment.
Sales will begin in Italy and France. Amazfit Body Composition Mat price is €39.9.
Source: https://4pda.to/2024/03/04/425023/umnyj_kovrik_amazfit_body_composition_mat_otsenili_v_39/
New registered medical devices
We publish a list of new medical devices registered from 03/01/2024 to 03/07/2024
Link to the list: [see. table in attachment]
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