News Digest 06.07.2023 - 07.07.2023

Regulators

For specific patients will be able to purchase Russian MI with the indication of the trademark

The Ministry of Health of the Russian Federation has submitted a draft Procedure for the formation of a list of medical devices and specialized therapeutic food products for the procurement of which the indication of a trademark is permitted if they are purchased for the needs of a particular patient. This may be based on individual intolerance or vital indications, and the decision must be confirmed by a medical commission. The list may include medical products registered in Russia.

Source: https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=139769


Market News

The first domestic NGS device enters the market

The Institute of Analytical Instrumentation of the Russian Academy of Sciences in cooperation with Syntol has completed the development of a domestic sequencer for mass parallel DNA sequencing. The device is called "Nanofor SPS" and operates on the principle of sequencing by synthesis using domestic reagent compatible with Illumina reagents.

Source: https://www.syntol.ru/news/pervyy-otechestvennyy-pribor-dlya-ngs-vykhodit-na-rynok.html?sphrase_id=72266

In Kerch City Hospital No. 1 named after N.I. Pirogov in the framework of the national project "Health Care" purchased modern equipment.

According to the territorial body of Roszdravnadzor for the Republic of Crimea and the city of federal significance Sevastopol, Zaporozhye region and Kherson region, in the department of radiosurgical methods of diagnosis and treatment of the State Budgetary Institution of the Republic of Crimea "Kerch City Hospital No. 1 named after N. I. Pirogov. Pirogov" commissioned an expert-class diagnostic complex for ultrasound studies with the ability to study brachiocephalic vessels, aorta, inferior vena cava, transcarnial studies, transthoracic and transesophageal echocardiography.

Source: https://t.me/roszdravnadzor_official/1576


Other

Russia has created a prototype of a medical device for online examination of patients

Students of the Moscow Institute of Physics and Technology have developed a prototype of a medical device that combines the functions of eight diagnostic devices, including a stethoscope, glucometer and tonometer. The press service of the National Technological Initiative (NTI) Platform told TASS that the development can be used at in-person and online appointments in medical organizations.

Source: https://nauka.tass.ru/nauka/18202993

News

News Digest 11.06.2026 — 19.06.2026
19.06.2026
Roskachestvo has identified issues with the registration and accuracy of blood pressure monitors; The Russian Ministry of Health has developed new instructions on how to handle citizen appeals; Revenue threshold for transition to VAT will be frozen until 2029
More
News Digest 05.06.2026 — 11.06.2026
11.06.2026
The Russian Government has amended the rules for maintaining the state register of medical devices; The Russian Ministry of Health has increased the number of medical specialties to 155; The Russian Government will allocate an additional 5 billion rubles for the purchase of glucose monitoring systems
More
News Digest 29.05.2026 — 05.06.2026
05.06.2026
The rule regarding the cancellation of registration of medical devices without an authorized representative is proposed to be postponed for a year; The Russian Ministry of Health has updated its procedures for monitoring the safety of medical devices and assessing their conformity; Amendments have been made to the Medical Device Safety Monitoring Procedure
More