News Digest 10.11.2023-13.11.2023
Regulators
Medical products will be transferred to a point-based evaluation system to gradually increase the share of Russian components and deepen localization
In order to stimulate the processes of deepening the localization of the production of medical devices on the territory of the Russian Federation, the Ministry of Industry and Trade of Russia has prepared changes to the annex to the Decree of the Government of the Russian Federation of July 17, 2015 No. 719 in terms of transferring the criteria for determining the level of localization of the production of medical devices to a point evaluation system.
These amendments provide for a gradual increase in the percentage of Russian components used in the production of medical devices and are aimed at creating additional incentives for the development and mastery of promising production technologies in the country. Thus, for example, reagent kits, orthodontic implants, various medical materials, microsurgical and dental instruments, vascular and heart valve prostheses, as well as containers for biosamples and other medical products will be transferred to a point system for assessing confirmation of the country of origin. We emphasize that for this nomenclature there are Russian manufacturers with registration certificates.
The proposed changes are aimed at reducing the dependence of the domestic market on foreign supplies.
Source: https://bit.ly/3MQMaOJ
Market news
R-Pharm brings to the market microfluidic chips for sperm sorting
The R-Pharm group of companies received a registration certificate (RZN 2023/21148 dated September 22, 2023) for microfluidic chips Fertile, Fertile Plus and Fertile Ultimate. These are sterile products for single use, the principle of which is to separate sperm according to their mobility in the microenvironment. The project is being implemented under an agreement with the Turkish biotechnology company Koek Biotechnology.
Other
In the USA, they developed “smart” breathable surgical gowns with pockets and a “holster”
American pharmaceutical distributor and developer of solutions for medical organizations, Cardinal Health, has launched the first surgical gown in the United States with chest pockets for storing instruments in operating rooms. Special clothing was developed jointly with doctors at the Mayo Clinic in Rochester (Minnesota), writes Becker's Hospital Review.
The unique design of the gown's pockets helps minimize potential contamination and inadvertent dropping of instruments outside the sterile area, the company said. With SmartGown™ EDGE, surgeons can store reusable instruments in the pockets and “holster” of the gown, reducing the need to transfer or change instruments during surgery, while promoting potential time savings and physician self-sufficiency.
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