News Digest 18.08.2023-22.08.2023
Regulators
The U.S. Bureau of Industry and Security (BIS) has issued guidelines for obtaining export licenses for medical devices for export, re-export and domestic movement to Russia and Belarus
On July 19, 2023, guidelines were issued for filling out a set of documents for obtaining a license for medical devices subject to US export control. We remind you that the list of such medical devices was significantly expanded on May 19, 2023.
The end-use/user statements in the document package must certify that verification has been made that the end-consignees or end-users of the application are civilian establishments providing medical services to civilians and not to military users.
Subject and term of the license. Licenses for export, re-export and movement within the country to Russia and Belarus are approved, as a rule, for a period of one year. License applications with relatively low transaction volume can be processed more quickly. It is recommended to narrow the scope of the license to one consignee/distributor and no more than 100 end users (preferably less) and a year's supply of quantity of goods.
Grouping of exported elements. It is recommended that similar items in your applications be grouped into broad categories to help BIS make decisions more quickly. At the same time, it is desirable to provide a detailed description of goods and specific Harmonized System codes (TN VED codes) for goods in order to get a decision faster.
Applications for export for patient care. Applications are more likely to go through the review process faster if they clearly show that the items will be used for direct patient care, for civilian patients in civilian hospitals. “Direct patient care” is defined as “direct face-to-face contact with patients for the purpose of diagnosis, treatment and observation”.
TN VED code. It is important to correctly indicate the TN VED code in the application. The license issued by BIS only allows transactions using the HS codes specified in the license. In case of incorrect classification of goods in the application, the license may not allow the transaction you are planning.
Source: https://t.me/MedPharmaPulse/585
Market news
The Center for Genetic Technologies of the National Research University "BelSU" has patented a camera for micro-operations
The camera is planned to be used for microsurgical operations and research, microinjections into cells and embryos of genetic material, organelles and spermatozoa. According to Aleksey Deikin, Director of the Joint Center for Genetic Technologies of the NRU BelSU, the patented model will help visualize objects with different optical densities without the need for staining. This will allow you to work directly in the examination of living cells, while providing an overview of their internal structures.
“Several such cameras have already been transferred within the framework of scientific cooperation to members of the Consortium for the Development of Genetic Technologies - the State Scientific Center for Virology and Biotechnology “Vector”, for whose specialists we have trained in the technique of creating transgenic animals.
Source: https://t.me/vademecum_live/11073
Other
New expert-class medical equipment has been put into operation at the Sevastopol Regional Vascular Center
New ventilators have an extended range of parameters that allow you to maintain respiratory functions in patients with complete inability to spontaneously breathe or respiratory failure.
As doctors explain, their advantage is also that the devices can operate both from the mains and from built-in batteries, which make it possible to use them in cases of power outages, allowing the device to be carried along with the patient. Also, the functionality allows you to quickly review the current state of the patient's ventilation. The panel displays tidal volume, lung compliance, airway resistance - at a critical moment, all this information will allow you to make a decision regarding therapy.
Another new device is a robotic bicycle ergometer. It is located in the Department of Neurology of the RSC and is intended for active-passive mechanotherapy as part of the early rehabilitation of patients with impaired functions of the lower extremities after neurological damage.
No less important in the recovery of patients is the kinesiotherapeutic suspension system for the treatment of diseases of the musculoskeletal system, the nervous system, including after strokes, traumatic brain injury, and spinal injury.
All equipment was purchased thanks to the regional program "Fight against cardiovascular diseases" of the national project "Health". One of the directions of the program is the re-equipment of the regional vascular center with medical equipment, including equipment for early medical rehabilitation.
Source: https://t.me/roszdravnadzor_official/1696
Three clinics in the Kaliningrad region received new operating tables
Mechanohydraulic operating tables of one of the leading Russian manufacturers of medical equipment are installed in the surgical rooms of the Pionersky, Svetlogorsk and Yantarny polyclinics. The new operating tables are highly comfortable. The multi-sectional design of the table, which is transparent to x-rays, allows performing various surgical manipulations, including those under x-ray control. The special coating allows fast and effective disinfection. A wide range of additional instruments, included in the package of such tables, allows you to perform almost the entire range of surgical procedures. Since the cabinets were equipped with this equipment, more than 60 outpatient surgical procedures of varying degrees of complexity have been performed.
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