News Digest 08.05.2024 — 13.05.2024
Regulators
Roszdravnadzor reminded and published on its website an explanation that at present the cancellation of registration certificates of foreign production is not carried out, applications for the cancellation of registration certificates of foreign production are not accepted
Cancellation of the state registration of a foreign-made medical device registered in accordance with the requirements of the legislation of the Russian Federation in the field of state registration of medical devices, based on the submission to the registration authority of an application from the manufacturer (manufacturer) of the medical device or an authorized representative of the manufacturer (manufacturer) of the medical device to cancel the state registration of the medical device products are not carried out.
Source: Федеральная служба по надзору в сфере здравоохранения (roszdravnadzor.gov.ru)
A scoring system has been introduced for manufacturers of culture media and wheelchairs
The government has established scoring criteria to evaluate the degree of containment of power wheelchairs and ready-made culture media for growing microorganisms. Changes were made to the Decree of the Government of the Russian Federation No. 719 dated July 17, 2015.
According to the document, for culture media it is necessary that the following operations be carried out on Russian territory:
- cooking - 30 points;
- bottling (packaging) - 20 points;
- sterilization – 30 points;
- mixing - 20 points.
In total, to confirm Russian or Eurasian localization, the manufacturer must score at least 60 points.
In addition, it is necessary that the legal entity has the rights to technical and design documentation for the production of products for a period of at least five years. It is necessary for the manufacturer to have structural units and (or) accredited laboratories responsible for checking the quality of products during the guaranteed shelf life, as well as the availability of equipment for the operations of the technological process for the production of media or a rental agreement for such equipment.
To confirm the production of electric wheelchairs in Russia, it is necessary to confirm the legality of the use of technical documentation for the products. The ratio of the use of Russian and foreign raw materials in the final cost will also be taken into account. Compliance with the percentage share of the cost of foreign raw materials used in the production of wheelchairs in 2024 should be no more than 50%, and by 2028 - no more than 40% of the price of the final product. In addition, to receive preferences, it is necessary that the registration dossier for a medical device indicate the place of its production in Russia or the EAEU.
The Ministry of Industry and Trade proposed to evaluate the localization of the production of medical products using a point system back in 2021. This was required to reduce the country’s dependence on foreign components and help the development of the medical industry.
In December 2022, the government adopted a point system for determining the country of origin for 24 medical products. Then, scoring criteria were established to assess the degree of localization of 18 types of medical equipment. In particular, the list included computed tomographs, mammographs, hardware and software systems for recording and processing X-ray images, as well as ultrasound machines.
Order of the Federal Service for Surveillance in Healthcare dated April 25, 2019 No. 3239 will no longer be in force
Roszdravnadzor has developed a draft order “On invalidating the order of the Federal Service for Surveillance in Healthcare dated April 25, 2019 No. 3239 “On approval of the administrative regulations of the Federal Service for Surveillance in Healthcare for the provision of public services for receiving and recording notifications of the start of activities in the field of circulation of medical devices (except for clinical trials of medical devices, their production, installation, adjustment, use, operation, including maintenance, and repair)" - https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=147423
Order No. 3239 is declared invalid in accordance with the Federal Law of July 24, 2023 No. 366-FZ “On Amendments to Certain Legislative Acts of the Russian Federation”, changes that are made to acts of the Government of the Russian Federation approved by the Decree of the Government of the Russian Federation dated February 28, 2024 No. 219 - http://static.government.ru/media/files/WXc7x2AjONY5ELNSMw2XJ8cUalHQQQxU.pdf
Market news
R-Pharm has already registered three CT machines from the Chinese Minfound, according to data from Roszdravnadzor. Although the group recently denied plans to import them
In April, the CT systems ScintCare CT 16, ScintCare CT 128 and QuantumEye 789 were registered. Simultaneously in March and April, the R-Pharma joint venture with Canon “Arpi Canon Medical Systems” registered two new models of CT devices from the Japanese manufacturer - Aquilion Serve (TSX- 307A) and Aquilion Lightning (TSX-036A).
Source: https://t.me/delotom/407
Other
UrFU will begin training specialists in applied AI for medicine
A new undergraduate educational program “Applied Artificial Intelligence” (AI) will appear at the Ural Federal University (UrFU) in 2024. It will train specialists for various industries, including healthcare. Graduates will be able to develop IT solutions for actually used equipment, processes and technologies.
Students will be working on AI projects from their first year. The main focus of the project work will be to evaluate the effect obtained from the implementation of a new IT or AI solution. The curriculum includes subjects that are related to the development of engineering and technological aspects of activity. This year it is planned to recruit about 100 people.
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