News Digest 29.11.2024 — 06.12.2024
Regulators
Regulatory vocabulary. Industry legal acts of November 2024
• Simplified registration of medical devices may be extended until January 1, 2028
Draft Resolution of the Government of the Russian Federation "On Amendments to Certain Acts of the Government of the Russian Federation"
The Ministry of Health of the Russian Federation has prepared a draft government resolution, according to which it is proposed to extend until January 1, 2028, special conditions for the circulation of medical devices, including state registration of series (batches) of medical devices, established by Government Resolution No. 430 of April 3, 2020.
It is also planned to extend the validity of Government Resolution No. 552 of April 1, 2022, which approves the specifics of the circulation and state registration of medical devices in the event of their defect or risk of defect associated with the introduction of economic restrictions against Russia.
The changes are aimed at strengthening the resilience of the Russian economy in the face of sanctions.
• The Ministry of Health plans to update the process for obtaining permits for the use of in vitro diagnostic medical devices
Draft Resolution of the Government of the Russian Federation "On Amendments to the Resolution of the Government of the Russian Federation dated November 24, 2021 No. 2026"
The Ministry of Health of Russia proposed to limit the submission of documents for obtaining permits in paper format. In accordance with the proposal, all applications must be sent to Roszdravnadzor exclusively in electronic form through the public services portal. Documents must be signed with an enhanced qualified electronic signature.
It is also planned to reduce the time for making decisions on issuing permits from 33 to 28 working days, and the time for confirmation or refusal - from 14 to 13 working days. If the changes are approved, Roszdravnadzor will have to make a decision on whether to begin reviewing applications for reissuing permits within four working days instead of the current five. It is also proposed to reduce the time for reviewing applications for reissuing permits from 10 to one working day. The Ministry of Health also intends to speed up the examination of the quality, safety and effectiveness of medical products, carried out by the authorized institution of Roszdravnadzor, from 30 to 10 working days.
VERBA LEGAL lawyers believe that changes in the current rules can contribute to the optimization of regulatory control and automation of processes in the field of licensing activities.
Source: https://vademec.ru/news/2024/12/02/normativnaya-leksika-otraslevye-pravovye-akty-noyabrya-2024-goda/
GOST and national standard on artificial intelligence (AI) in healthcare published
GOST: https://d-russia.ru/wp-content/uploads/2024/11/gost-r-71737-2024.pdf
National standard: https://d-russia.ru/wp-content/uploads/2024/11/pnst-961-2024.pdf
The government approved restrictions on the circulation of TSR based on information from the labeling system
The Russian government approved a resolution with additional groups of goods in a document containing lists of cases in which the sale of products subject to mandatory labeling with identification means is prohibited due to the presence of or the absence of certain information in the Honest Sign system. The framework document with 12 lists was adopted on November 21, 2023. It included, in particular, tobacco products, as well as antiseptics and dietary supplements. Later, in March 2024, the resolution prescribed information on the basis of which the sale of medical devices and wheelchairs is prohibited. Seven more groups of goods appeared, among which there are technical rehabilitation equipment (TRE). Thus, from October 1, 2025, TRE will be prohibited from being sold if there is no information about their labeling in the system, if the Honest Sign indicates a ban or suspension of the sale and use of products by decision of regulators, as well as if the expiration date of the goods has expired. From October next year, it will also be prohibited to sell rehabilitation equipment if the labeling system indicates that the product has been withdrawn from circulation, or if there is no information on its introduction on the portal. In addition, from the set day, a ban on the sale of TSR with a verification code that does not correspond to the characteristics of the identification means, including the structure and format established by the marking rules, will come into effect. In this case, the ban will be issued in real time.
From October 1, 2025, similar rules will come into effect for drugs for veterinary use. The same cases of the ban on the sale of goods from November 1, 2024 came into effect for skin antiseptics and dietary supplements.
From March 1, 2025, the sale of medical devices subject to mandatory labeling and included in the "black lists" or not labeled will be restricted in real time. For wheelchairs, the ban on the sale of products that do not comply with the marking rules will be established not in real time (offline).
Mandatory labeling of medical devices is consistently introduced from 2023, the operator of the system is "Operator-CRPT". Monitoring is designed to prevent the illegal production and circulation of medical devices. From 1 s September 2023, marking became mandatory for wheelchairs. From October 1, 2023, the rules came into effect for air purifiers and orthopedic shoes, and for hearing aids, coronary stents, CT and absorbent underwear - from March 1, 2024.
Market news
Kursk region will receive 623 million rubles for the purchase of medical products for beneficiaries
The Government of the Russian Federation allocated 623.4 million rubles to provide one-time financial assistance to the budget of the Kursk region, on the territory of which the federal level of emergency response is in effect. The funds will be used to purchase medicines, medical devices and specialized therapeutic nutrition products for disabled children and federal beneficiaries.
All products are intended for citizens permanently residing in the Kursk region. Purchased drugs and medical devices will be sent to patients of preferential categories on prescription either free of charge or with a 50% discount for outpatient treatment. The service is provided to disabled people, including disabled children, participants in the Great Patriotic War and Chernobyl victims.
The Russian Ministry of Health has been instructed to ensure the conclusion of an agreement on the provision of a transfer for the budget of the Kursk region no later than 30 days after the publication of the order, and the agency must also monitor the targeted and effective use of budgetary allocations. The report to the Government of the Russian Federation should be submitted no later than March 1, 2025.
In October 2024, the Russian Government announced its intention to finance the purchase of medical devices for temporary accommodation centers (TACs) in the Kursk region. For these purposes, 10.15 million rubles were allocated from the reserve fund.
With the help of interbudgetary transfer funds, about 45 thousand test systems for the diagnosis of coronavirus infection and influenza will be purchased, intended for diagnosing diseases in those who are in temporary accommodation centers. It is also planned to purchase at least 188 ultraviolet bactericidal mobile irradiators - air recirculators for air disinfection in the temporary accommodation centers.
In 2025, a plant for medical products for cardiac surgery will appear in Novosibirsk
The idea of creating a new specialized enterprise arose at the Meshalkin National Medical Research Center back in 2021. The project implementation became possible thanks to a grant from the Ministry of Industry and Trade of the Russian Federation, issued on a shared participation basis. For these purposes, the Ministry of Industry and Trade allocated 50 million rubles, the center itself - 13.5 million, and the company "Intruline" invested 8 million. In addition, the industrial partner invested an additional 100 million rubles in the construction of the plant. The company "Intruline" began its activities in the Novosibirsk region in 2016. It is engaged in the production of medical instruments and equipment.
The progress of the project was reported by the General Director of the Meshalkin National Medical Research Center Alexander Chernyavsky at the Zolotaya Dolina scientific and production forum in Novosibirsk. He specified that it is planned to produce four types of medical products. These are a children's pulmonary artery prosthesis, a transcatheter aortic valve, a transcatheter mitral valve and a prosthesis for hybrid aortic surgery.
"All tests have been completed for the children's prosthesis. It is at the registration stage with Roszdravnadzor. Tests are currently being completed for the other developments. According to the terms of the grant, we must receive registration certificates by July 1, 2025,” the center’s director specified. After successful completion of the tests and receipt of permits, serial production of the new products will begin.
According to Alexander Chernyavsky, the sanctions imposed against Russia have made the creation of high-quality domestic medical equipment especially relevant. Many foreign analogues are unavailable today or their deliveries are delayed. Therefore, the launch of new production is of strategic importance for Russian healthcare.
In April 2024, the Meshalkin Center successfully completed preclinical trials of a unique domestic prosthesis for children's pulmonary artery. The nitinol stent is capable of independently opening inside the vessel due to its “shape memory” property.
In September of this year, experts from the Meshalkin NMIC announced the creation of a device capable of moving a working donor heart.
In Vladimir, the production of medical polymers will be organized for 900 million rubles
The Governor of the Vladimir Region, Alexander Avdeev, spoke about the conclusion of a number of agreements at the ECG forum in Suzdal, which will attract investment to the region. Thus, the Volginsky Plant of Medical Polymers will invest 900 million rubles in the creation of a plant in Vladimir.
The enterprise intends to produce medical polymer products and pharmaceutical packaging. Investors plan to create production by the end of 2026. The capacity of the future plant is not disclosed, it is planned to create 175 jobs.
According to SPARK-Interfax, Volginsky Plant of Medical Polymers LLC was registered on November 20, 2024 in the Vladimir region. The company's main activity is the production of medical instruments and equipment. The main beneficiary is Vladislav Pomerantsev - he has 90%, the remaining 10% belongs to Maxim Dadev.
According to Alexander Avdeev, at the forum, the authorities also signed an agreement with the Ellara company, which is investing 200 million rubles in expanding the existing production of import-substituting pharmaceutical substances. The work is planned to be completed by the end of 2025 and create 30 new jobs there. The regional governor did not provide any other details.
According to SPARK-Interfax, Ellara LLC was registered in the Vladimir region in 2009. The company is engaged in the production of drugs and materials used for medical and veterinary purposes. The beneficiary is Vitaly Borovikov.
Over the past three years, the pharmaceutical company has shown an almost threefold increase in revenue - from 1.2 billion in 2021 to 3 billion rubles in 2023. The corresponding dynamics were ensured by the development of sales in the hospital channel, as well as the intensification of work with pharmacy retail. In an interview with Vademecum publisher Dmitry Kryazhev, Ellara Director Valentin Borovikov spoke about how the company plans to develop further.
Khabarovsk UFAS fined suppliers of medical products 41 million rubles
The Office of the Federal Antimonopoly Service (UFAS) for Khabarovsk Krai fined participants in a cartel agreement in the medical products market 41.8 million rubles. We are talking about the companies OOO Spektr-DV, AO Vector-Best-Amur, OOO Medias, OOO ALEF, OOO VostokMedBusiness, OOO Company Dalmedical, OOO Medtekhnika-Service, the press service of the UFAS reported. The cartel participants entered into an anti-competitive agreement that covered 648 public procurements for a total starting (maximum) price of 373 million rubles. Violations were discovered during tenders for the supply of medical products to medical organizations in the region.
The FAS previously transferred the materials to law enforcement agencies to decide on initiating a criminal case - the company executives may be accused of restricting competition (Article 178 of the Criminal Code of the Russian Federation).
The government will allocate additional funds for preferential lending for the purchase of imported insulin
The Russian government has allocated 5.058 billion rubles for additional subsidies for the special program for preferential lending for the purchase of priority imported products, which has been in effect since mid-2022. The list of such goods includes, among other things, insulins, antibiotics, hearing aids, orthopedic devices and other pharmaceutical and medical products.
According to the order, the subsidy will be sent to credit institutions and the State Development Corporation VEB.RF "to compensate for lost income on loans issued for the purchase of priority import products." Additional funding will subsidize loans previously issued to importers for a total of about 140 billion rubles and maintain a preferential rate for borrowers.
In total, more than 14.6 billion rubles have been allocated in the federal budget in 2024 to support the program. The funds are intended to achieve the result of providing a subsidy to "increase the volume of imports of priority import products through preferential lending to organizations."
The Ministry of Industry and Trade has been instructed to monitor the targeted and effective use of budgetary allocations, as well as to submit a report to the government by February 1, 2025.
A special program for preferential lending for the purchase of priority imported products was launched in May 2022. It was noted that more than 37 billion rubles will be allocated for its implementation. The program is designed to help enterprises reduce current costs and establish supplies of necessary goods. The period for which companies can receive a loan depends on the purpose of the loan. Thus, for the purchase of raw materials and components, the preferential rate will be valid for one year, for equipment and means of production - three years.
At the start of the program, the list of priority imported products included antibiotics and drugs consisting of a mixture of two or more components, vaccines. The list also included surgical and dental materials, hemostatic agents, cotton wool, gauze, bandages, X-ray machines, diagnostic reagents and a number of other goods.
In June 2022, the program was expanded, adding drugs consisting of mixed or unmixed products and packaged for retail sale, hormone-based contraceptives and dry milk mixtures for I am baby food.
The next changes to the list were made in October of the same year. The program nomenclature was supplemented with insulins, immunological products, medicines containing vitamins, and drugs for retail sale containing iodine or its compounds. Of the medical devices, the list included orthopedic devices, including crutches, surgical belts and bandages, splints and other devices for the treatment of fractures, artificial body parts, hearing aids and other devices that are worn on oneself, with oneself, or implanted in the body to compensate for an organ defect or its inoperability.
Other
Software developed in Russia to assess the risk of developing coronary heart disease
Scientists from the Novosibirsk State Technical University NETI have developed a method that allows diagnosing the likelihood of developing coronary heart disease (CHD) in young people. The work was carried out by order of the laboratory of clinical biochemical and hormonal studies of therapeutic diseases of the Research Institute for Therapy and Preventive Medicine (NIITPM), the university's press service reported.
The methodology for assessing the risk of developing CHD was created based on inflammatory, oxidative and lipid biomarkers of 200 patients. For the convenience of working with a collection of models that take into account the specifics of interpreting a set of biochemical indicators, a software module was developed. The user can enter laboratory test data, and the system will issue a result characterizing the numerical risk of developing coronary atherosclerosis and coronary heart disease in the patient. Based on the obtained result, in the case of medium or high risk assessments, the doctor has grounds to prescribe additional examinations and clarify the diagnosis for the patient.
As part of the project, scientists proposed a convenient option for systemic visualization of results, which allows displaying various indicators and their deviation from the conventional "norm-pathology" boundary. Based on the generated visual image, it is possible to see which of the diagnosed subsystems of the body affects the risk of developing coronary heart disease. This diagram was proposed to be used as a clarifying diagnostic model that can be applied for express diagnostics and screening examination of large groups of the population.
A new method for assessing the presence of coronary heart disease in young people has been patented and is being used by specialists from the Research Institute of Therapeutic Medicine.
FMBA scientists patented a portable breath analyzer for diagnosing respiratory infections
Specialists from the Center for Strategic Planning and Management of Medical and Biological Health Risks (CSP) of the Federal Medical and Biological Agency of Russia and the N.S. Enikolopov Institute of Synthetic Polymer Materials of the Russian Academy of Sciences have developed a device for non-invasive express diagnostics. The "electronic nose" is capable of detecting COVID-19, tuberculosis and other airborne diseases in just a few minutes, the press service of the Federal Medical and Biological Agency reported.
As the head of the agency, Veronika Skvortsova, said, the principle of operation of the device is based on the detection and mathematical analysis of signals from gas sensors that respond to exhaled air. The improved design of the unit takes into account the influence of the external atmosphere on the recorded responses. Machine learning and artificial intelligence (AI) methods are used to analyze the results, and the screening study time does not exceed five minutes.
During studies at leading infectious disease medical institutions, the device demonstrated high sensitivity and specificity in the differential diagnosis of tuberculosis and COVID-19 with other acute diseases (ARI, pneumonia, whooping cough, meningitis), including in patients with concomitant diseases (asthma, diabetes). Data are not provided.
The FMBA CSP received a positive decision to issue patents for the developed device for analyzing volatile organic compounds in human exhaled air and a unit for detecting volatile organic compounds in human exhaled air.
Newly registered medical devices
We publish a list of new medical devices registered from 11/29/2024 to 12/06/2024
Link to the list: [see table in the attachment]
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