News Digest 22.11.2024 — 29.11.2024
Regulators
New rules for registering medical devices are planned to be adopted by March 1, 2025
The government must approve new rules for registering medical devices by December 1, so that the document can be adopted by March 1, 2025, said Dmitry Pavlyukov, Deputy Head of Roszdravnadzor, during a round table "On measures of state support for the production of medical equipment and machinery", which was held on November 27 in the Federation Council, a correspondent for "FV" reports.
Over the past four years, the admission of medical devices to the market has changed dramatically, Pavlyukov said.
Thus, according to Government Resolution No. 552, low-risk products included in the list are registered under the guarantee that the manufacturer will confirm the quality, safety and effectiveness of the products in a state laboratory. "This measure is being successfully applied," said a representative of Roszdravnadzor.
Under simplified schemes for making changes to the registration dossier, manufacturers can provide the service with their own test reports. "If the methodology is transparent, then there is no need to contact accredited laboratories, spend time and money on this," Pavlyukov explained. "We are guided by the fact that no manufacturer will change raw materials without making sure of their quality."
The government is currently reviewing a draft of new rules for registering medical devices, approved by federal executive bodies, he added. The document provides for several fundamental innovations.
Manufacturers of low-risk medical devices will be able to make changes to the dossier without an examination if they voluntarily undergo an assessment of quality management systems in production. "In essence, this is a notification procedure. It will affect medical devices of the first and second risk classes, non-sterile products: here we can trust the manufacturers," the deputy head of the service noted.
The procedure for registering medical devices that have passed tests in a state laboratory and in the federal national medical research center for clinical evaluation becomes administrative. To obtain registration, the manufacturer will need to provide test results to Roszdravnadzor and wait no more than 15 days. "Under the new rules, there is no need to conduct an examination as part of the state registration service. All assessments are conducted before applying to a government agency," Pavlyukov added. "We are convinced that this will allow us to build a comfortable seamless track for manufacturers who will work with clear, transparent laboratories."
Specialists from these medical organizations can advise on what improvements are required in the product - from systemic ones related to the purpose of the products to design, for which doctors also have certain wishes. "If the product is inconvenient to work with, the doctor will simply put it in the corner. We believe that involving leading specialists in assessing medical devices will speed up the procedure for admission to the market," Pavlyukov explained.
According to him, manufacturers are waiting for the adoption of new registration rules. "Our task is to ensure that this document comes out of the government before December 1 and comes into force on March 1, 2025," the representative of Roszdravnadzor summarized.
Features of procurement from a single supplier will be extended until 2025
Roszdravnadzor proposed to amend the second paragraph of its own order No. 2983 of 05/16/2023. The draft order on this is under public discussion until December 11.
The authors of the document propose to extend the validity of order No. 2983 until 2028 (currently the order is valid until 2025). It approved a list of information on non-original components for the maintenance of medical devices and a list of documents for maintaining a register of such spare parts and their manufacturers.
It is also planned to extend the validity of RF Government Resolution No. 339 of 03/10/2022; the corresponding amendments were prepared by the Ministry of Finance. The document, which is intended to be extended, approves temporary additional cases of procurement of goods, works and services for state and municipal needs from a single supplier, as well as the procedure for their implementation. The decree is intended to be extended until December 31, 2025 (it is currently valid until December 31, 2024).
The Ministry of Industry and Trade approved the lists of drugs and medical devices with a long production cycle
The Ministry of Industry and Trade of the Russian Federation approved the list of drugs and medical devices with a production cycle of over nine months or a long period of their implementation. Manufacturers of such goods are allowed to pay excise tax at a later date - 15 months instead of nine months from the date of purchase of the pharmaceutical substance ethyl alcohol by the organization. The list is based on the proposals of the manufacturers themselves. In total, the Department for Development of the Pharmaceutical and Medical Industry received proposals from 86 organizations. and nine manufacturers of drugs and medical devices. However, the Ministry of Industry and Trade considered the proposals of only two companies to be appropriate: JSC Natsimbio and the Federal State Unitary Enterprise Scientific and Production Center Pharmzashchita of the Federal Medical and Biological Agency of Russia. The list includes 21 drugs and 6 medical devices, most of which are manufactured by the company Mikrogen (the parent company is Natsimbio, part of the Rostec State Corporation).
Market news
New regions will receive 751 million rubles for the purchase of medical equipment
The Russian government will allocate 751 million rubles from the reserve fund to purchase medical equipment for the needs of clinics in new regions - the DPR, LPR, Zaporizhia and Kherson regions. The funding will make it possible to purchase 29 units of equipment, including mammographs and magnetic resonance tomographs.
Russian Prime Minister Mikhail Mishustin noted that federal funds will speed up the renewal of infrastructure in clinics and hospitals in the new regions. Stationary X-ray machines, mammographs, CT and MRI scanners are planned for purchase.
The Russian Ministry of Health has been instructed to ensure that agreements are concluded with regional authorities within 30 calendar days after the order is issued. The department must also monitor the targeted and effective use of budgetary allocations and submit a report to the government by March 1, 2025.
According to the government order, the largest tranche is provided for the Luhansk People's Republic - 320 million rubles, the Zaporizhia region will receive 255.5 million rubles, the Donetsk People's Republic - 160 million rubles, and 15.5 million rubles are provided for the Kherson region.
In April, the Russian Government allocated 679.17 million rubles to support the work of mobile teams and field multifunctional hospitals in the DPR, LPR, Kherson and Zaporizhia regions. The funds were distributed between federal medical centers, including for the purchase of medicines, medical devices and disinfectants.
Kursk region will receive 623 million rubles to purchase medical products for beneficiaries
The Russian government has allocated 623.4 million rubles to provide one-time financial assistance to the budget of the Kursk region, where 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. The 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 department must also monitor the targeted and effective use of budgetary allocations. The report to the Government of the Russian Federation must be submitted no later than March 1, 2025.
In October 2024, the Russian Government announced its intention to finance the purchase of medical products for temporary accommodation centers (TACs) in the Kursk region. 10.15 million rubles were allocated from the reserve fund for these purposes.
With the help of interbudgetary transfer funds, about 45 thousand test systems for the diagnosis of coronavirus infection and influenza will be purchased, designed to diagnose 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 TACs.
Other
Russian manufacturers have developed a new product for the treatment of acute pancreatitis
Skolkovo resident Russian company PANDEX in partnership with JSC MedSil brought to market a new medical device for the treatment of patients with acute pancreatitis. This is the pancreatoduodenal catheter DecomSist, created with the support of the pharmaceutical company Dr. Reddy's Laboratories. It combines existing methods of treating the disease and affects a number of key pathogenetic factors, reducing the severity of the pathology, the frequency of surgical interventions and the duration of patient treatment.
Source: https://t.me/vademecum_live/16436
Russia has created a complex for testing magnetic resonance tomographs
Scientists from the National Research Nuclear University MEPhI (NRNU MEPhI) and the Gamma Knife Moscow Center have created a hardware and software complex for testing magnetic resonance tomographs (MRI) for geometric distortions. The product is being tested at the National Medical Research at the N.N. Burdenko Neurosurgery Institute and the Hadassah Medical Clinic, the university's press service told MV.
The product is a cylindrical phantom that is scanned on an MRI, and software that processes the resulting images to identify geometric distortions. According to the project manager, Associate Professor of the Medical Physics Department at MEPhI Alexander Dalechin, the use of the developed complex by medical physicists makes it possible to check any tomograph for compliance with the requirements of stereotactic irradiation and make such checks routine.
RUB 4.5 million received by the project team in the first cycle of the MEPhI Accelerator were spent on developing the phantom and software for analyzing geometric distortions of MRI. The plans include scaling the product to different device designs, as well as finding customers among 120 Russian stereotactic radiation therapy centers and more than 750 MRI centers. In addition, the startup plans to supply the hardware and software package together with a domestic tomograph manufactured by Rosatom Health Technologies.
Earlier, scientists from the Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Department of Health (NPKTS DiT DZM) developed the first fetal phantom in Russia to set up magnetic resonance imaging technology for pregnant women. With the new medical device, which imitates organs, tissues and parts of the human body, the time for conducting the study will be reduced, which will ensure its widespread use as an additional diagnostic method for pregnant women, MV reported.
MIPT scientists are developing a portable biosensor for diagnosing diseases
MIPT scientists are working on creating a portable diagnostic device that will allow detecting viruses directly at the point of medical care, the university reports.
The new diagnostic method is based on the use of a lens thinner than a human hair - a metalens, which allows you to examine markers of various viruses at the molecular level. "We are currently developing a miniature metasurface on glass substrates, which will then be transferred to a chip. Visually, it will resemble familiar electronic circuits. We have already created an optical setup capable of detecting single molecules. This approach will allow us to more quickly detect disease biomarkers in biological fluids at early stages and at low concentrations in the future," said Alexander Barulin, a leading researcher at the MIPT Laboratory of Controlled Optical Nanostructures.
According to him, scientists have also already developed numerical models that can be used to create integrated photonic circuits. This, as the scientist noted, will open up the possibility of creating portable devices for conducting tests and diagnostics, including directly at the patient's home.
"The diagnostic method that we offer is superior to traditional PCR testing, which is slower and requires multi-stage amplification," Barulin emphasized.
The final goal of the project is to create a working metasurface on a chip and implement it in a portable biomaterial analyzer that will help quickly diagnose diseases at the point of medical care.
Then the scientists plan to move on to finding investors and planning production scaling.
Scientists have developed a nanosensor for diagnosing cancer and Alzheimer's
A unique non-invasive nanosensor for measuring copper in the body in real time was created by NUST MISIS scientists as part of an international team. According to them, this opens up new possibilities for diagnosing and treating diseases such as Alzheimer's disease and cancer. The results are published in the journal Analytical Chemistry.
Newly registered medical devices
We publish a list of new medical devices registered from 11/22/2024 to 11/29/2024
Link to the list: [see table in the attachment]
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