News Digest 13.09.2024 — 16.09.2024
Regulators
Review of industry regulations
— Resolution No. 1196 of August 31, 2024 "On Amendments to the Resolution of the Government of the Russian Federation of March 12, 2022 No. 353".
The government extended the simplified procedure for confirming the conformity of imported and manufactured products for another year. Manufacturers of goods are allowed to confirm the conformity of their quality based on their own test data. Such goods include medical devices, disinfectants and cosmetics.
— Resolution No. 1246 of September 11, 2024 "On Amendments to Certain Acts of the Government of the Russian Federation".
The government amended the lists of medical device codes subject to value added tax at a tax rate of 10%. Thus, the OKPD codes were brought into line with the current list of Rosstandart.
Source: https://pharmvestnik.ru/content/news/Obzor-otraslevyh-normativno-pravovyh-aktov-302.html
Market news
In the Chuvash Republic, the medical rehabilitation department of City Clinical Hospital No. 1 continues to be equipped with new modern equipment
The Federal Service for Surveillance in Healthcare constantly monitors the implementation of the National Project "Healthcare" in all regions of the country. According to the Territorial Body of Roszdravnadzor in the Chuvash Republic, thanks to the Federal Project "Optimal Medical Rehabilitation for Restoring Health" of the National Project "Healthcare", the medical rehabilitation department of City Clinical Hospital No. 1 received equipment for diagnosing pathologies of the musculoskeletal system and restorative treatment using the biofeedback method.
The new device helps to build a rehabilitation program more effectively, taking into account the individual needs of the patient, which will not only significantly expand the possibilities of rehabilitation, but also provide patients with the most modern methods of health restoration after severe injuries, diseases of the musculoskeletal system, and other neurological pathologies.
During treatment, miniature inertial sensors are attached to the patient's body, which record the parameters of movement and electromagnetic pulses, which allows you to accurately determine the level of muscle damage. The training of joint motor activity itself takes place in a game form, which makes it understandable, exciting and effective for patients of all ages.
It should be noted that over the 6 months of this year, 2,264 people underwent rehabilitation in the outpatient department of medical rehabilitation, which is more than 2 times more than in the same period in 2023. The increase in the coverage of patients with medical rehabilitation was made possible by new modern equipment.
Source: https://t.me/roszdravnadzor_official/2859
Other
Rosatom to present first Russian CT scanner by the end of 2024
An experimental model of a CT scanner (CT) will be created by Rusatom RDS, a subsidiary of the Rosatom State Corporation, by the end of this year. This was announced at the Technoprom-2024 forum by Valentin Smirnov, head of the Nuclear Medicine department of Rosatom State Corporation, TASS reports.
A pilot version of the CT is being developed on the basis of a domestic emitter. The cost of investments in the new project was not announced, it is only known that the creation of an X-ray emitter is about 1.193 billion rubles.
According to Valentin Smirnov, about 4,000 foreign-made CT machines are currently used in Russia, and their maintenance requires spending significant funds to replace X-ray emitters.
Previously registered Russian devices used imported components, which created a dependence on foreign supplies, writes Vademecum. The publication cites the previously registered KTR tomograph of the Research and Production Complex Electron, but notes that it can be equipped with a Chinese or German scanner, as well as emitters manufactured in Germany, China, the Netherlands and Japan.
Previously, foreign companies GE Healthcare, Philips and Canon Medical Systems planned to localize production in Russia, Vademecum also writes. Some of these projects were implemented, for example, the assembly of Optima CT at the facilities of MTL LLC in the Moscow region. Localization of CMS equipment was also being prepared at the facilities of the joint venture R-Pharm and CMS Arpi Canon Medical Systems. Philips intended to assemble CT at the site of Rentgenprom JSC. However, in May 2023, many components, including X-ray tubes, were included in the list of dual-use products, which significantly complicated their receipt by Russia even for medical purposes. This has actualized the need to create our own diagnostic equipment. In general, the annual volume of the domestic market for computer tomographs is estimated at 20-30 billion rubles.
"Rusatom RDS" is an industry integrator of the State Corporation "Rosatom" in the field of manufacturing equipment and electronics. In addition to working on a computer tomograph, research is carried out here in other areas of medicine. In Last year, the new laser system "LaserTool" for surgery, developed by Rusatom RDS, was tested. In February 2024, Rusatom RDS presented the "Sanginox" device for cardiology, cardiac surgery and critical care medicine, which has no analogues in the world. Many of the company's new products were shown at the international exhibition "AtomExpo 2024".
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