News Digest 04.09.2023-06.09.2023
Regulators
Compression stockings are included in the list of simplified registration
The Interdepartmental Commission has again expanded the list of medical devices for simplified registration according to Decree of the Government of the Russian Federation No. 552 of April 1, 2022. Five items have been added to the list, including reusable compression socks and stockings, reagents and an analyzer. The total number of medical products has reached 1,935 types.
The simplified procedure is extended to a laboratory blood gas analyzer for in vitro diagnostics, multiple blood gas analytes, hemoximetry and IVD electrolytes - reagents and control materials, a kit for mixing or injecting orthopedic cement. In addition to them, the list includes reusable compression socks and stockings.
The effectiveness of Roszdravnadzor will be assessed by the labeling of medical devices
An indicator of the effectiveness of Roszdravnadzor’s work will be a decrease in the number of series or batches of medical products recalled by the regulator, the volume of illegal trafficking and expired medical products. The indicators were introduced as criteria for assessing the work of Roszdravnadzor after the introduction of a labeling system for medical devices.
The amendments are included in the order of the Government of the Russian Federation No. 345 dated February 15, 2023. Thus, the volume of illegal trafficking should decrease by 7% in 2024 and by 12% in 2025. The number of medical devices with an expired expiration date or an urgent registration certificate, the period of permitted circulation of which has expired, should be reduced by 15% and 30%, respectively. Similar figures should be achieved in relation to the number of series or batches of medical products recalled by Roszdravnadzor due to non-conformity of consumer packaging.
Indicators will be calculated annually, taking into account changes to the regulatory certificate. The parameters of the target indicators may be revised depending on practice, as noted in the footnote to the amendments made to the order.
From 1 September 2023, labeling has become mandatory for wheelchairs, skin antiseptics and dietary supplements. In a month - from October 1, 2023 - it will apply to air disinfectants and orthopedic shoes.
For hearing aids, coronary stents, CT scans, absorbent underwear and medical gloves, mandatory labeling will be introduced from March 1, 2024. The operator of the system is “Operator-CRPT”. The marking is designed to prevent the illegal production and trafficking of medical devices.
Market news
The Ministry of Industry and Trade intends to continue purchasing mobile medical complexes from a single supplier
The Ministry of Industry and Trade plans to continue purchasing mobile medical systems (MMC) from a single supplier in 2023-2024. The explanatory note states that a draft government decree has also been prepared on identifying a single executor and on allocating funds from the reserve fund for vehicles equipped with medical equipment. This document was sent to the Cabinet of Ministers by letter dated August 23.
President Vladimir Putin demanded that the delivery of the secondary battery be accelerated. In 2021, he said that instead of 1,300 complexes for residents of villages and remote settlements provided for by the national project, only 1,003 were delivered.
In 2023, it was planned to deliver 299 PMKs to the regions. Thus, the limit on their purchases established within the framework of the federal project “Development of the Primary Health Care System” was exhausted. In this regard, the Ministry of Health proposed to allow subjects to purchase such complexes in 2024-2025 in accordance with the Decree of the Government of the Russian Federation No. 1304 of October 9, 2019 “On the modernization of primary healthcare.”
Imports of intravenous catheters almost tripled in 2022
In 2022, the import of intravenous catheters to Russia increased 2.7 times to 36.5 million units. Imports of intravenous catheters to Russia increased 2.7 times (+172%): from 13.4 million to 36.5 million units, follows from the BusinesStat analysis. This is a record dynamics for at least several years: in 2021, amid the COVID-19 pandemic, imports decreased by 53%, in 2020 they grew by 5.5%, in 2019 by 38%, in 2018 by 6%. . Mostly medical products were supplied from India.
Analysts note that the growth in imports is partly due to the sanctions imposed by Western countries on Russia: domestic companies sought to create stocks of the most necessary medical instruments and consumables, and “since the Russian market for venous catheters is formed exclusively by imported products, medical institutions were interested in providing themselves with these products for future use."
Source: https://medvestnik.ru/content/news/Import-vnutrivennyh-kateterov-vyros-v-2022-godu-pochti-vtroe.html
Other
The structure of the Moscow Department of Health will be able to test AI systems for the EAEU
The Center for Diagnostics and Telemedicine of the Moscow Department of Health has the opportunity to assess the performance of artificial intelligence systems of the EAEU countries. It is planned that developers will be able to obtain permission to use their products simultaneously in several countries.
The Center for Diagnostics and Telemedicine of the Moscow Department of Health has received the opportunity to conduct technical tests and research on medical artificial intelligence systems for registration within the Eurasian Economic Union (EAEU), the center’s press service reported. Thus, developers can obtain permission to use their products simultaneously in Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan - it is planned that this will “accelerate the introduction of new technologies into medical practice, and patients will receive faster and higher-quality diagnostics.”
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