News Digest 15.03.2024 — 18.03.2024
Regulators
The draft Concept for the further development of the common market for medical devices in the Eurasian Economic Union has been published. Public discussion will last until 04/12/2024 (project passport attached)
The sale of illegal and expired products will be blocked using a labeling system.
Sales of illegal medical products will be blocked using a labeling system, follows from the government decree. According to the document, from March 1, 2025, cash registers will not be able to allow the sale of illegal medical products and wheelchairs.
Online, when scanning a labeling code, the cash register software (software) will access the labeling system and receive from it information about the requested product. If one of the criteria is triggered, the product will not be sold. The resolution approved the following blocking criteria: the product has not been put into circulation, there is no data on the code or its application, the product has already been taken out of circulation, the sale of the product is blocked by the control (supervisory) body, the verification code does not meet the requirements, the expiration date has expired (if it is established for a medical device ).
As the operator of the Honest Sign labeling system explained to MV, the innovation will affect only retail participants who already have experience with blocking at checkouts for other groups of labeled goods. The new mode does not require additional equipment - the mechanism is implemented by accessing the cash register software marking system, which is already installed by the participants in the turnover.
In March 2024, the Ministry of Industry and Trade proposed conducting a labeling experiment for a new group of goods. These include condoms, syringes, infusion systems, ventilators, masks and fillers. Roszdravnadzor will have full access to the traceability of the entire range of goods included in the experiment. This will allow the regulator to assess their sufficiency and staffing of medical institutions, and in the future, block the circulation of those medical products whose quality has been questioned.
Market news
Rostec launched a system for remote monitoring of the condition of pregnant women
The Rostec digital platform “Personal Medical Assistants” has added the ability to track the condition of a pregnant woman, the press service of the state corporation reported on March 18. New medical products – fetal monitors for monitoring the fetal heartbeat – will be connected to the system, which allows for remote monitoring of health indicators. In addition, pregnant women participating in the project will be given tonometers and glucometers.
The results of measurements of glucose levels in capillary blood, systolic and diastolic pressure, heart rate of the mother and child, as prescribed by the doctor, will be sent to the Personal Medical Assistants platform, from where they will be transferred to medical information systems for the doctor to monitor the condition of the woman and her unborn child at different stages pregnancy.
The project starts in March at the Mother and Child hospital in Moscow and medical network clinics in Yaroslavl, the Astrakhan and Vladimir regions, the republics of Altai, Bashkortostan and Sakha (Yakutia). Methodological management of the project will be carried out by the National Medical Research Center of Obstetrics, Gynecology and Perinatology named after. acad. IN AND. Kulakov together with Russian National Research Medical University named after. N.I. Pirogov.
The information system “Personal Medical Assistants” was launched at the beginning of 2023 for remote monitoring of the health status of people with chronic diseases. More than 37 thousand medical devices are already registered in it. The system operator is Ruselectronics.
More than 3 billion rubles will be allocated for medical care of Rosatom Closed Joint-Stock Company
In 2024, the Rosatom State Corporation together with the Federal Medical and Biological Agency of Russia will continue to implement the project “Improving the quality and availability of medical care in the cities of presence.” The program operates in 18 closed administrative-territorial entities (CLATEs). The total project budget for this year will be more than 3 billion rubles.
The funds will be used to continue the development of Industrial Medicine Centers, expand the work of the Coordination Center for Oncology, repairs in medical institutions and their additional equipment.
“In 2024, taking into account the positive results from the implementation of the project, the concern decided to expand it to two more “nuclear” cities - Sosnovy Bor (Leningrad Region) and Polyarnye Zori (Murmansk Region). Thus, the number of cities where Rosenergoatom nuclear power plants are located has almost doubled this year,” Rosatom said.
The implementation of a joint project between the state corporation and FMBA, aimed at improving medical care in “nuclear” cities, started in 2022. Last year it was implemented in Desnogorsk in the Smolensk region, Zarechny in the Sverdlovsk region and Udomlya in the Tver region. The budget amounted to 1.7 billion rubles.
Source: https://vademec.ru/news/2024/03/18/na-medobsluzhivanie-zato-rosatoma-napravyat-bolee-3-mlrd-rubley/
A new children's clinic will be built in Yekaterinburg
Thanks to the implementation of the regional program "Modernization of primary health care" of the national project "Healthcare" in the city of Yekaterinburg, Sverdlovsk region, it is planned to build a new children's clinic of the State Autonomous Institution of Public Health "Children's City Hospital No. 15, Yekaterinburg".
The outpatient clinic will serve about 25 thousand people of the attached population, and will accommodate about 700 people per shift, which will help relieve the two existing hospital buildings from visits.
It is planned to erect a building 7 floors high. The future children's clinic will house several departments (two pediatric departments with 28 sections, a consultation department, departments of preventive and emergency care, rehabilitation treatment, functional and radiation diagnostics), as well as a day hospital with 22 beds, a conference room with 200 seats, a registration desk and call center. Laboratory and diagnostic services, including radiology, ultrasound diagnostics, clinical diagnostic laboratory will help strengthen the hospital's diagnostic service.
It is expected that the medical institution will operate in two shifts, and the number of full-time employees of the children's clinic will be 452 people. Young visitors will be received by pediatricians and specialized specialists (surgeons, neurologists, ophthalmologists, orthopedists, traumatologists, cardiologists, gastroenterologists and other specialists).
Construction work is currently underway at the site in accordance with the work schedule. The contractor must put the building into operation no later than July 30, 2025.
Source: https://t.me/roszdravnadzor_official/2350
Several laboratories for the production of medical devices will open on the basis of the interuniversity campus in Chelyabinsk
In one laboratory they will create dentures from nanotitanium, in another - ectoprostheses, and in the third they will carry out photopolymer 3D printing for use in dentistry and surgery.
According to Natalya Nurieva, vice-rector for strategic development, science and innovation at South Ural Medical University, the creation of a laboratory for the production of nanotitanium products, which will open first, will be an important step forward for the university. The laboratory will create great prospects for the development of scientific capabilities and their implementation in practice, and will inspire students to new achievements and work in the region. It will also provide students with a chance to get acquainted with advanced technologies and become a platform for conducting high-quality research that contributes to the development of science and improvement of practice.
The technological partner of the university laboratory will be a company specializing in the production of dental implants, using domestic nanocrystalline titanium. Prostheses made from this material are durable and have good survival rate. The university believes that the emergence of laboratories will expand the geography of application of nanotitanium products. Finished products will be supplied not only to the cities of the Southern Urals, but also to medical institutions in other regions of Russia. There are also plans to organize the export of products to Belarus, Kazakhstan, Uzbekistan, Brazil, Vietnam and India.
The program for creating a network of campuses started in Russia in 2021 on behalf of the President of Russia as part of the national project “Science and Universities”.
Source: https://t.me/MedTechIndustry/1256
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