News Digest 09.08.2023 - 11.08.2023
Regulators
Localization scoring system introduced for 18 types of medical equipment
The Government of the Russian Federation has approved a point system for determining the country of origin for 18 types of medical equipment. Under the tightening of localization rules, ventilators, computed tomographs, mammographs, x-ray equipment, sterilizers, ultrasound and laboratory equipment for working with PCR fell. Now, in order to be recognized as domestic and receive preferences, companies will have to confirm the implementation of a minimum volume of technological operations, and the threshold of points will increase until 2025.
Points will be awarded for compliance with four procedures - the use of Russian raw materials, the use of domestic components, the performance of technological operations during assembly, and the volume of research work, which will be proportional to the amount of revenue. Mandatory requirements will also be introduced for the availability of technical documentation, R&D, a quality management system (QMS), the availability of production facilities and minimum technological operations - points will not be awarded for them.
The number of points required to recognize products as domestic will increase from 2023 to 2025 and will approach the bar of 100–120 points for a number of products.
In November, it became known that the Ministry of Industry and Trade plans to extend the point system for assessing the level of localization to medical equipment in 2023.
The Circle of Kindness Foundation was simplified the import of unregistered medicines and medical devices
The government has simplified the import of unregistered medicines and medical devices by the Circle of Good. So, for this it will be enough to provide a copy of the extract from the decision of the expert council.
The government has amended the rules for the import of unregistered medicines and medical devices by the Circle of Good. Such resolution No. 1316 of August 10, 2023 was published on the legal information portal.
Changes have been made to the Rules for the Importation of Medicinal Products for Medical Use, approved by Decree of the Government of the Russian Federation No. 1590 dated 09/22/2021.
To obtain the appropriate permit, the Fund will only need to attach a copy of the extract from the decision of the expert council to the application for the issuance of an import permit. Previously, for example, it was necessary to provide a copy of this decision.
The list of indicators has been updated to assess the effectiveness of the work of state bodies on labeling
The government has approved a list of indicators that will be used to evaluate the effectiveness of the work of federal executive authorities in labeling a number of products. We are talking about dietary supplements, wheelchairs, water and mineral water.
In turn, the Ministry of Labor will study such indicators as a decrease in the share of wheelchairs provided to people with disabilities in the order of early replacement by decision of the medical and technical commission, as well as a decrease in the volume of their secondary turnover.
Market news
Motorika will place bonds for 300 million rubles in autumn 2023
The Russian developer of functional bionic prostheses Motorika intends to enter the debt market in the fall of 2023. The company will issue bonds for a total amount of 300 million rubles. The placement will be handled by IB Sinara and IC Dialot. The funds will be used to increase the production of existing products, develop and launch new products and enter new foreign markets.
Motorik expects to bring lower limb prostheses and neurostimulators to the market in 2024 to combat chronic pain, parkinsonism, multiple sclerosis and epilepsy. In addition, the company intends to move towards the development of assistive technologies.
Motorika is a developer of products using artificial intelligence technologies. Since 2015, the company has been creating and manufacturing functional hand prostheses with an individual design.
Source: https://vademec.ru/news/2023/08/10/motorika-osenyu-2023-goda-razmestit-obligatsii-na-300-mln-rubley/
Other
Moscow scientists create artificial skin for medical training models
A training model with imitation of skin - an artificial material that is similar in elasticity and visual qualities to real human skin - was created by employees of the Center for Diagnostics and Telemedicine of the Moscow Department of Health. With the help of phantoms, specialists will be able to hone their skills in ultrasound diagnosis of aneurysms and thrombosis of cerebral vessels, neoplasms and tumor foci in the mammary and thyroid glands, improve measurement accuracy and learn manipulations under ultrasound navigation.
Source: http://www.t.me/vademecum_live/10956
The government redistributed subsidies to the regions for the construction of medical facilities
The government redistributed subsidies to the regions in 2023-2024 to co-finance capital investments in medical facilities. We are talking about those institutions that should be built as part of the federal projects "Fight against cancer", "Development of children's healthcare" and "Development of healthcare infrastructure", follows from a document published on the official website.
General subsidies in 2023 increased - instead of 38.8 billion rubles. it is planned to send almost 40 billion rubles to the regions. The difference (1.1 billion rubles) will be covered by a deduction from subsidies for 2024: instead of 18.7 billion rubles. only 17.6 billion will be sent.
New registered medical devices
We publish a list of new medical devices registered from 08/04/2023 to 08/11/2023
https://asiamc.ru/uploads/blogs/2023-08-11/medregs_20230811.pdfNews
