News Digest 09.10.2023-13.10.2023

Regulators

The Ministry of Health has finalized the updated rules for registration of medical devices

The Ministry of Health of the Russian Federation presented a revised draft of the rules for registering medical devices, replacing the current procedure approved by government decree No. 1416. The document retains the main ideas contained in the regulations developed by the department in the spring of 2023. The expected entry into force of the government decree has been postponed to April 1, 2024.

Source: https://vademec.ru/news/2023/10/11/minzdrav-dorabotal-obnovlennye-pravila-registratsii-medizdeliy-/

Roszdravnadzor initiated the creation of a new commission on defects in medical devices

Roszdravnadzor plans to create a new special interdepartmental commission that will deal with the problem of defects in medical devices.

It is planned that the commission will determine a list of products with existing defects or risks of their occurrence, as well as other products “for which the interdepartmental commission has received proposals for the supply of medical products at a price below the market average.”

Source: https://medvestnik.ru/content/news/Roszdravnadzor-iniciiroval-sozdanie-novoi-komissii-po-defekture-medizelii.html

Market news

More than 90% of anesthesiologists spoke out against the ban on the purchase of imported ventilators

The overwhelming majority (92%) of practicing anesthesiologists and resuscitators spoke out against the ban on government procurement of imported artificial lung ventilation devices (ventilators). Such data were obtained from a survey of doctors organized by the Association of Anesthesiologists and Resuscitators of Russia (AAR), MV drew attention.

Source: https://medvestnik.ru/content/news/Bolee-90-anesteziologov-vyskazalis-protiv-zapreta-na-zakupki-importnyh-IVL.html?utm_source=TG_post&utm_medium=Group&utm_campaign=Bolee-90-anesteziologov-vyskazalis-protiv

Other

Skolkovo resident plans to install a neuroimplant that restores vision in 2025

“It is planned that in 2025 we will be able to supply a person with the first implant that restores vision,” he said at a specialized session of the Biotechmed forum in Sochi.

During the session, the CEO of the company producing robotic prosthetics "Motorika" Andrey Davidyuk said that the company itself co-invests in research projects, including with universities, because the "brightest minds" gather there.

Source: https://nauka.tass.ru/nauka/18985133

New registered medical devices

We publish a list of new medical devices registered from 10/06/2023 to 10/13/2023

https://cont.asiamc.ru/uploads/blogs/2023-10-13/65299d381406b.pdf