News Digest 07.02.2025 — 14.02.2025
Regulators
The Russian Ministry of Health has cancelled documents explaining the rules for state registration of medical devices, which will cease to be effective at the beginning of March
The regulator's decisions affect the order of the Ministry of Health from May 16, 2013 No. 300n "On approval of requirements for medical organizations conducting clinical trials of medical devices, and the procedure for establishing compliance of medical organizations with these requirements", as well as the order of the department from February 8, 2013 No. 58n "On approval of the Regulation on the Ethics Council in the Sphere of Circulation of Medical Devices".
Both legal acts will cease to be effective on March 1, 2025, on this day the new Rules for state registration of medical devices will come into force. The document was approved at the end of November 2024. The updated rules, in particular, introduce a one-stage procedure for registering domestically produced medical devices, subject to technical and toxicological testing at the All-Russian Research and Testing Institute of Medical Equipment (VNIIIMT) of Roszdravnadzor, and clinical trials at federal medical centers (NMIC) accredited by the Ministry of Health.
Source: http://publication.pravo.gov.ru/document/0001202502130013
The Ministry of Health will change the requirements for technical and operational documentation of medical devices
The Ministry of Health of the Russian Federation has developed a draft order with requirements for technical and operational documentation of medical device manufacturers. Similar aspects are recorded in the version of the order valid until September 1, 2025 - if approved, the new document will come into force on the same date and will be relevant until 2031. Among other things, the developers propose to include in the documentation for medical devices information about their clinical trials, history of circulation in international markets, recorded adverse situations during use, as well as other information. Thus, the authors of the document intend to expand the list of data on medical devices concerning their safety and the possibility of verification. According to the draft order, manufacturers of medical devices must indicate in the technical documentation information about the name and purpose of the medical device, information allowing its identification (model number, brand, etc.), the type of product according to the nomenclature classification. However, in addition to these provisions, which are also in the current version of the document, the authors of the changes propose to include in the documentation data related to the explanation of the properties and characteristics of the medical device, a description of its main functional elements (diagrams, photographs and drawings demonstrating the main parts of the product), information about the presence or absence of a history of circulation of the medical device in international markets, cases of adverse events as a result of its use, a description of corrective actions taken in response to such situations. In addition, if the draft document is approved, manufacturers of medical devices will indicate in the technical documentation a brief description of their previous and similar modifications in circulation in the countries of the Eurasian Economic Union (EAEU), as well as on international markets, information on the identification of production sites where such products are manufactured, on the verification and validation of software in the design of the medical device, a report on its clinical efficacy and safety (including detailed information on the clinical trials conducted).
In the operational documentation, the developers of the order also propose to indicate the summarized results of clinical trials conducted for the purpose of its registration, information on the limitations or incompatibility of any drugs or biological materials with the medical device, information on the need to send messages to the manufacturer about adverse events resulting from the use of the product.
The number of regulatory entities that, if approved, will be affected by the new procedure, according to the consolidated report, exceeds 2.5 thousand. The costs of implementing mandatory requirements for six years from the expected date of entry into force of the draft order will amount to between 300 million and 3 billion rubles. The financial and economic justification for the draft order states that its implementation will not require additional federal budget funds.
In early December 2024, the Russian Government approved new Rules for the Registration of Medical Devices, which will be in effect from March 1 to December 31, 2025, until the transition to the EAEU rules. Thus, a one-stage procedure for registering domestically produced medical devices will be in effect in Russia, subject to technical and toxicological testing at the All-Russian Research and Testing Institute of Medical Equipment of Roszdravnadzor, and clinical trials at federal medical centers accredited by the Ministry of Health.
In January 2025, the Ministry of Health presented a draft federal law, according to which the regulation of the circulation of medical devices in Russia is proposed to be transferred to the acts of the EAEU. If the document is approved, it will come into force on January 1, 2027. According to the explanatory note, the purpose of the bill is to eliminate state duties for the actions taken by the authorized federal executive body when registering medical devices.
The list of alcohol-containing medical devices includes 13 more items
The Government of the Russian Federation has approved an updated list of products that contain alcohol and are not subject to regulation by the Federal Service for Control of Alcohol and Tobacco Markets (Rosalkogoltobakkontrol, RATK). Thus, the list includes 13 medical devices, 39 items are excluded from the list.
Three of the 13 medical devices included in the list are kits for DNA/RNA extraction from biomaterial "AmpliTest", and two more are reagent kits for the detection and quantitative determination of SARS-CoV-2 RNA, as well as for in vitro diagnostics "AmpliSens". The list includes the reagent for fixation of cytological preparations "MLT-Fixator-spray", two sets of reagents for detection of hepatitis A virus (HAV) RNA in clinical material and environmental objects by PCR with electrophoretic detection of amplification products in agarose gel "AmpliSens", sets of reagents for extraction of RNA/DNA from clinical material "RIBO-prep" in forms 1 and 2, a set of reagents for detection of aplele 5701 of locus B of the human major histocompatibility complex (HLA B*5701) in clinical material by PCR with hybridization-fluorescence detection in real time "AmpliSens", as well as sets of reagents for detection of Gardnerella vaginalis and Varicella-Zoster virus DNA in clinical material by PCR with hybridization-fluorescence detection "AmpliSens". Two medical products that had been on the list since January 2023 were excluded from the list - reagent kits for isolating RNA/DNA from RIBO-prep clinical material in forms 1 and 2. The remaining 37 excluded products are reagent kits for detecting Mycoplasma genitalium DNA, hepatitis B virus, Chlamydia trachomatis and hepatitis C virus RNA in AmpliSens clinical material, RNA of influenza A and influenza B viruses in AmpliSens biomaterial, RNA/DNA of pathogens transmitted by ixodid ticks in AmpliSens biomaterial. Four years ago, the Russian Ministry of Health developed and approved specialized Rules for the formation of a list of alcohol-containing medical products, the production, manufacturing and circulation of which are not covered by the federal law "On state regulation of the production and circulation of ethyl alcohol, alcoholic and alcohol-containing products and on limiting the consumption (drinking) of alcoholic products" and which are not subject to the control of the Russian Alcohol and Drug Control Commission. In particular, all alcohol-containing medical products fell under regulation, regardless of the proportion of ethanol in them. Now, in order not to fall under the law, a manufacturer of medical products must include their products in a special list, confirming that the products meet one of the criteria. In addition, manufacturers of medical products are required to record and declare the volume of production, supply and use of ethanol and transfer data to the EGAIS. The authority to form the list is vested in a commission consisting of representatives of the Ministry of Health, the Ministry of Industry and Trade, Rospotrebnadzor, Roszdravnadzor, RATK, FAS, representatives of the NMIC and industry associations, in particular, Delovaya Rossiya. In October 2024, the Roszdravnadzor Commission for the Formation of Alcohol-Containing Medical Products updated the list, including 11 medical products. These are mainly reagents for PCR studies and DNA/RNA extraction developed and manufactured by the Central Research Institute of Epidemiology of Rospotrebnadzor. Another eight products are recommended to be excluded.
Market news
The Government of the Ivanovo Region will sell Medtekhnika JSC
The Government of the Ivanovo Region approved the "Forecast plan for the privatization of property owned by the Ivanovo Region for 2025". It is planned to sell 100% of the shares of Medtekhnika JSC, the company is engaged in the trade of medical equipment and machinery.
According to Rusprofile, Medtekhnika JSC is owned by the regional government. The company's revenue in 2023 amounted to 10 million rubles, the loss was 767 thousand rubles. The regional government noted that Medtekhnika JSC is a consistently unprofitable enterprise.
According to the audit report, a large number of violations were found in the company's operations and reporting, including the distortion of financial performance indicators.
Source: https://ivanovolive.ru/news/22738
Russian Red Cross to receive 49.8 million rubles to purchase medical equipment for hospital in Ethiopia
The Russian government has ordered the Ministry of Health to allocate budgetary allocations of up to 49.8 million rubles to provide a subsidy to the All-Russian public organization "Russian Red Cross" (RRC). The funding will be used to purchase medical equipment for the Dejazmatch Balchi Hospital in Addis Ababa (Ethiopia).
The list for purchase includes 15 items. Thus, the Russian Red Cross will purchase two anesthesia and respiratory devices and the same number of portable X-ray machines with mains power supply for its hospital, as well as two pieces of each - portable ultrasound systems, ventilators, portable transport ventilators, biochemical automatic analyzers, operating lamps, sterilization devices, autoclaves and bedside monitors. In a single quantity, they plan to purchase a syringe pump, a laparoscopic stand, a defibrillator, a washer-disinfector, a hematology analyzer.
The government order notes that the Ministry of Finance of the Russian Federation should ensure funding for expenses, the Federal Customs Service of Russia - the implementation of customs operations on a priority basis, and the Ministry of Foreign Affairs of the Russian Federation should assist in resolving issues of delivery and transfer of medical equipment to hospital representatives.
The charitable organization "Russian Red Cross" has been operating since 1867. It has five federal areas of activity and 85 regional branches. In June 2018, the RCC managed to raise 161 million rubles to provide assistance to victims of the fire in the Zimnyaya Vishnya shopping center. In May 2021, the RCC raised 73.2 million rubles in donations for the families affected by the shooting at Kazan Gymnasium No. 175. Since 2013, the question of determining the legal status of the organization has been raised. The RCC did not have a legal status, but was an independent organization that cooperates with the state and performs a number of functions on its behalf. In May 2021, the Ministry of Health developed a draft federal law "On the Russian Red Cross", designed to eliminate the legal gap in the organization's activities. At that time, the explanatory note noted that the uncertain legal status of the RCC "creates additional difficulties for the society's activities and does not correspond to the established world practice on this issue." No decision was made on the bill. Three years later, in July 2024, the same department presented a draft federal law "On the All-Russian Public Organization "Russian Red Cross". The draft sets out the legal status of the RRC, the fundamental principles of its activities, the property of the organization, the goals and objectives of its activities, and the forms of support for the RRC from state authorities and local governments. The document was eventually approved.
Other
A bill on artificial intelligence (AI) prescription of drugs has been submitted to the US House of Representatives
A bill has been submitted to the US House of Representatives that would allow "AI and machine learning technologies to independently prescribe drugs approved by the Food and Drug Administration (FDA)," Mobihealthnews reports.
If the initiative is approved, the law will recognize AI as a "practicing specialist who has a legal license to use drugs." That is, in fact, the actions of AI will be equated to the actions of a person.
Source: https://www.mobihealthnews.com/news/proposed-legislation-paves-way-ai-prescribe-drugs
Newly registered medical devices
We publish a list of new medical devices registered from 02/07/2025 to 02/14/2025
Link to the list: [see table in the attachment]
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