News Digest 02.10.2023-04.10.2023

Regulators

Simplified registration of medical devices will be transferred to electronic form

The Ministry of Health of the Russian Federation has developed amendments to government decree No. 552 of April 1, 2022, regulating the accelerated registration of potentially defective medical devices. In the proposed version, documents for registration can be submitted through the functionality of the government services portal, and the rules will be linked not to the paper registration dossier, but to the register entry.

The development of an electronic account for submitting documents by the applicant is planned as part of the departmental digital transformation program of Roszdravnadzor for 2024. The amendments, if approved, will come into force on April 1, 2024.

Source: https://vademec.ru/news/2023/10/03/uproshchennuyu-registratsiyu-medizdeliy-perevedut-v-elektronnyy-vid/

 A list of medical products for equipping regional vascular centers has been approved

The Ministry of Health has determined what medical products are needed to equip, re-equip or retrofit regional vascular centers and primary vascular departments in medical organizations subordinate to the authorities of the constituent entities of the Russian Federation or local governments. The document comes into force on January 1, 2024.

The list contains 31 names of medical products.

Source: https://www.consultant.ru/legalnews/23454/?utm_source=yxnews&utm_medium=desktop&utm_referrer=https%3A%2F%2Fdzen.ru%2Fnews%2Fsearch%3Ftext%3D

Market news

In Krasnodar, the production of disposable catheters will be launched for 184 million rubles

The Industrial Development Fund (IDF) of the Krasnodar Territory will finance the organization of the production of disposable catheters. The April company will receive a loan in the amount of 184 million rubles to launch the plant. The decision, according to the regional government, will cover part of the needs of medical institutions and partially abandon imported products.

The products are included in the import substitution action plan in the Russian medical industry, therefore, according to company representatives, they will be in high demand.

Source: https://vademec.ru/news/2023/10/03/v-krasnodare-za-184-mln-rubley-zapustyat-proizvodstvo-odnorazovykh-kateterov/

Other

Scientists have proven the effectiveness of bone implants made from Russian polymers

The possibility of practical use of bone implants made from domestic biodegradable polymer was experimentally demonstrated by scientists from the Siberian Federal University.

Scientists are working to create biodegradable polymer materials for 3D printing of tissue matrices. Such products are needed for structural remodeling of bone tissue, when the body’s own resources are insufficient and it is necessary to fill the volume of the defect using implants.

Source: https://ria.ru/20230925/nauka-1898041482.html