News Digest 13.09.2023-15.09.2023
Regulators
Genetico will undertake clinical trials of medical studies
Roszdravnadzor has included Genetico centers in the list of medical organizations that have the right to conduct laboratory and clinical laboratory studies of medical devices for their registration on the territory of the EAEU countries.
Source: https://t.me/vademecum_live/11396
Russian manufacturers of medical devices will be refunded the value added tax (VAT) paid
The bill, developed by the Ministry of Industry and Trade, was approved by the government commission. As indicated in the explanatory note, manufacturers of medical products "are not VAT payers" and therefore cannot apply the deduction of the "input" value-added tax that they pay when purchasing components. Thus, the cost of Russian medical equipment increases. "This creates unequal fiscal conditions in comparison with foreign products imported into Russia, since for such products the exporting country reimburses their manufacturers for VAT," the authors note. Preferential taxation will be abolished for the import of foreign products.
Source: https://t.me/delotom/231
Various types of medical products can be combined into one lot, at the conclusion of offset contracts
Adjustments were made to the Decree of the Government of Russia No. 620 dated April 19, 2021. We are talking about public procurement of medical devices, according to the results of which a contract with counter investment obligations (offset contracts) is concluded between the region and the manufacturer.
Now, with such purchases, it is allowed to combine medical products of various types into one lot. It is assumed that this will reduce the number of procurement procedures and speed up the delivery of necessary products to medical institutions.
Source: https://t.me/MedTechIndustry/1161
Market news
UOMZ has updated components for neonatal equipment for 25 million rubles
Ural Optical and Mechanical Plant named after E.S. Yalamov spent 25 million rubles on the modernization of neonatal products to reduce the share of foreign components in them. The funds were received from the budget of the Sverdlovsk region. We are talking about a heater for newborns "Radiant heat-BONO" and an open resuscitation system for newborns ORS-BONO.
Other
UNN named after. Lobachevsky together with the BFU. Kant is developing a neurointerface to speed up the reaction in the elderly
The neurointerface is based on transcranial magnetic stimulation (TMS), in which the cerebral cortex is stimulated by short magnetic pulses, which is used in the treatment of depression, attention deficit, as well as other functional disorders. It is supposed to start using this technology to accelerate human reactions.
Currently, scientists believe that repeated sessions of magnetic stimulation can lead to the accumulation of the effect of accelerating brain reactions. With the help of an accurate neural network, brain states were recorded in which information processing was disrupted. The researchers used this data to develop a machine learning method that allows predicting human brain errors in reactions to visual stimuli or in tests for coordination of movements based on EEG data.
Source: https://t.me/vademecum_live/11374
New registered medical devices
We publish a list of new medical devices registered from 08.09.2023 to 15.09.2023
https://asiamc.ru/uploads/blogs/2023-09-15/65048c57b7cfb.pdfNews
