News Digest 24.05.2024 — 27.05.2024

Regulators

The experiment on marking syringes, fillers and condoms will begin in September

The government approved Resolution No. 620 of May 17, 2024 on conducting an experiment on labeling certain types of medical products, including condoms, syringes, fillers, infusion systems, test tubes and medical masks. The experiment will begin on September 1, 2024 and will last until August 31, 2025.

The list of medical products that participate in the pilot project in the approved resolution completely coincides with the draft document. It included those categories of goods in which there is a high proportion of illegal trafficking, violations, or an additional tool for government control is needed. Thanks to the experiment, Roszdravnadzor will have access to traceability of the entire range of goods, which will help assess their quality and the staffing of medical institutions.

Source: https://pharmvestnik.ru/content/news/Eksperiment-po-markirovke-shpricev-filerov-i-prezervativov-nachnetsya-v-sentyabre.html


Market news

A domestic test system for personal identification has been developed in Crimea

At the Research Engineering Center “Genetic and Cellular Biotechnologies” of the Crimean Federal University. Vernadsky developed a test system for laboratory research on personal identification. Experts say that domestic technology has every chance to occupy its niche in the market, where at the moment there are practically no similar solutions, Izvestia writes.

The test system is based on the well-known method of molecular biology, where analysis is performed using polymerase chain reaction (PCR). A distinctive feature of this development is the use of more accessible and cheaper components and reagents compared to foreign analogues. In addition, the system is highly accurate due to the analysis of 25 individualizing markers of human DNA, while imported products use from 13 to 18 markers. A study using the proposed test system takes from 7 to 10 days and is based on the analysis of short tandem repeats in human DNA.

Source: https://pharmmedprom.ru/news/v-krimu-uchenie-razrabotali-otechestvennuyu-test-sistemu-dlya-identifikatsii-lichnosti/


Other

Russia will expand an experiment on remote monitoring of pregnant women

The Ministry of Economic Development plans to conduct an experiment on remote monitoring of pregnant women using a cardiotocograph - a device that will record electrical impulses of the fetal heart and will allow monitoring its vital activity, as well as the tone of the uterus.

The draft government decree introduces changes to the Program of the experimental legal regime in the field of digital innovations in the field of medical activities using technologies for collecting and processing information on the health status and diagnoses of citizens in relation to the implementation of the socio-economic development initiative of the Russian Federation “Personal Medical Assistants” (Government Decree RF No. 2276 dated 12/09/2022).

Source: https://medvestnik.ru/content/news/V-Rossii-provedut-eksperiment-po-distancionnomu-nabludeniu-za-beremennymi.html

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