News Digest 31.07.2023 - 02.08.2023

Regulators

The State Duma proposed to control the work of foreign analytical companies

A number of deputies of the State Duma of the Russian Federation introduced a draft law aimed at regulating the work of analytical companies, primarily foreign ones, researching, among other things, the pharmaceutical and medical markets of Russia. It is proposed to introduce a register of such organizations, as well as to allow only operators that are 80% owned by Russian companies and store data on domestic servers to work.

The document amends No. 381-FZ "On the basics of state regulation of trading activities in the Russian Federation".

The explanatory note to the document notes that for the past 20 years in Russia, a number of Western companies, including those from unfriendly countries, have been conducting research and collecting data on Russian commodity markets, including the processing of data on public health, pharmacies and medicines. At the same time, domestic companies use such data, which requires additional legislative regulation of analytical activities.

Source: https://sozd.duma.gov.ru/bill/412669-8#bh_note

Officials will be fined for inaccurate statistics in the Uniform State Health Information System

Russian President Vladimir Putin approved a law developed by the Ministry of Health, which provides for the introduction of punishment for officials of relevant regional departments for providing inaccurate statistics to the Unified State Health Information System (EGISZ). We are talking about fines and suspension from work. Industry experts note that regional officials often embellish the real state of affairs and enter either unreliable or incomplete statistics into the Unified State Health Information System.

Source: https://vademec.ru/news/2023/05/29/v-gosdumu-vnesen-zakonoproekt-o-nakazanii-chinovnikov-za-nedostovernuyu-statistiku-v-egisz/


Market news

The former CEO of Philips Russia and the CIS headed Johnson&Johnson

Maxim Kuznetsov has been with the Russian office of Johnson & Johnson since 2022 as Managing Director of Medical Technology. Kuznetsov replaced Ekaterina Pogodina as CEO of the company, who has held this position since 2019.

From 2005 to 2022 Maxim Kuznetsov was an employee of Philips. In 2017, he became CEO of the company in Russia and the CIS.

Source: https://t.me/ssecretzdrav/41

Unim signed a contract with the Nizhny Novgorod Regional Clinical Dispensary

The cooperation of the parties involves the introduction of software (Unim platform) for morphological diagnostics in the region. It is planned to pass the materials of 5,000 patients through the system. At the moment, the license for this is estimated at 10 million rubles.

In 2022, Unim was bought out by the Tashir Medica company, which is part of the Tashir Group of Companies Samvel Karapetyan.

Source: https://t.me/ssecretzdrav/42

R-Pharm has found a replacement for the American manufacturer of equipment for genetic testing

R-Pharm (supplied Illumina products to Russia before it left the country through Albiogen) began negotiations with a potential partner, the Chinese BGI Group.

The share of Illumina in the Russian market was estimated at about 80%. Both state medical institutions and private laboratories work on its equipment. The most obvious contender for the vacant niche is BGI. Illumina and BGI have been suing each other in the US over the past three years over patent infringement.

Source: https://www.vedomosti.ru/business/articles/2023/07/28/987327-r-farm-nashel-zamenu-amerikanskomu-proizvoditelyu-oborudovaniya-dlya-geneticheskih-testov


Other

The head physician of the Mordovian hospital was suspected of embezzlement in the purchase of ventilators

In Mordovia, investigators suspected the head physician of the republican clinical hospital of embezzling 9.5 million rubles. when purchasing ventilators. He bought them at an inflated price. The criminal case has been sent to court.

The Investigative Committee of Mordovia completed the investigation of the criminal case against the chief physician of the Republican Clinical Hospital named after V.I. S.V. Katkova. He was charged with embezzlement of funds (part 4 of article 160 of the Criminal Code of the Russian Federation) and illegal manufacture of technical means for surveillance (article 138.1 of the Criminal Code of the Russian Federation). Investigators have not released the name of the suspect. According to local media, we are talking about Vyacheslav Shchapov.

According to the investigation, in 2020, the head physician concluded two state contracts for the supply of artificial lung ventilation devices to a medical institution at an inflated cost, without conducting a mandatory market analysis for this. In the first case, when purchasing two devices, the cost of each medical device was overstated by more than 700 thousand rubles. In the second case, when purchasing four drugs - for 2 million rubles. Thus, more than 9.5 million rubles were spent in total.

Source: https:/ /pharmvestnik.ru/content/news/Glavracha-mordovskoi-bolnicy-zapodozrili-v-rastrate-pri-zakupkah-apparatov-IVL.html? utm_source=main

Genetico has registered a test for the detection of genetic abnormalities in the fetus by maternal blood

Genetico has received permission from Roszdravnadzor to use the Prenetix test, which is designed to identify the risk of developing fetal genetic abnormalities in the blood of a pregnant woman. Now medical institutions will be able to legally provide prenatal screening services with its help.

Prenetix became the third test approved for use in Russia. In addition to it, NIPT technology in the country is represented by two more registered medical devices, both developed by the American Illumina. The first certificate is owned by R-Pharm, the other by DNA-Technology.

Source: https://medvestnik.ru/content/news/Genetico-zaregistrirovala-test-dlya-vyyavleniya-geneticheskih-otklonenii-u-ploda-po-krovi-materi.html

Privolzhsky Research Medical University (PIMU) has developed a platform for remote rehabilitation of patients after prosthetics

The video library of the platform contains 522 videos with physical exercises designed for the patient to perform at home. In addition, there are tests, questionnaires and scales for evaluating results, as well as additional information materials.

Now the first ten patients who are undergoing rehabilitation after arthroplasty at the PIMU University Clinic are connected to the platform.

Source: https://t.me/vademecum_live/10868

News

News Digest 26.12.2025 — 16.01.2026
16.01.2026
Russia Extends Simplified Procedure for Registration of Medicines and Medical Devices; Transition to a single market for medical devices in the EAEU has been postponed for two years; Special Procedure for Circulating Medicines in Foreign Packaging Extended Until the End of 2027
More
News Digest 19.12.2025 — 26.12.2025
26.12.2025
ELTA Wins Lawsuit Against Roszdravnadzor Over Destruction of 17,000 Glucometers; A list of equipment for the modernization of radiology centers has been approved; Diakon-DS to Raise 332 Million Rubles for Import-Substituting Reagent Production
More
News Digest 12.12.2025 — 19.12.2025
19.12.2025
Russia Extends Special Regime for Importing Medicines and Medical Devices Until the End of 2027; Roszdravnadzor has developed regulations for the state registration of medical devices; The Russian Ministry of Industry and Trade has proposed changing the rules for labeling medical devices, effective June 1
More