News Digest 18.04.2025 — 25.04.2025
Regulators
The Ministry of Health has expanded the list of risk indicators for state control over the circulation of medical devices
The Ministry of Health of the Russian Federation has introduced a new risk indicator for violation of mandatory requirements used by Roszdravnadzor to control the circulation of medical devices. Previously, there were three reasons for inspection by the supervisory service.
Now, the risk indicators include failure to receive a repeated application from the developer or manufacturer to amend the documents contained in the registration dossier for a medical device within 180 working days from the date of Roszdravnadzor's refusal to change the registration dossier. This also includes the return of the application for amendments and documents, termination of further consideration of the application, provided that there is an offer to sell such a medical device, including remotely.
In October 2024, the Ministry of Health also planned to increase the number of risk indicators for violation of mandatory requirements used by Roszdravnadzor to control the circulation of medical devices. The agency proposed to include in the reasons for inspection the presence of information about two or more deviations in the functioning of a medical device within six months of its use in a clinic, and to count deviations that did not entail a threat of harm to the health and life of citizens. However, the corresponding order has not yet been approved.
The Ministry of Health established the current criteria in the summer of 2023. Risk markers include a twofold or more increase in the number of documents on the results of clinical trials of medical devices for a calendar year compared to the previous one, the receipt of an application for a license for the maintenance of medical devices (or amendments to the relevant documents), and others.
In November 2021, the Government of Russia approved a new regulation on the licensing of the maintenance of medical devices. The document exempts from regulation the maintenance of medical devices with a low risk class, as well as legal entities or individual entrepreneurs engaged in the maintenance of their own medical equipment. The new regulation also exempts manufacturers or authorized representatives of foreign manufacturers who service only their own brand of equipment from some licensing requirements, including the availability of a quality management system, a list of equipment and measuring instruments.
The regulator will review the codes of medical devices for exemption from VAT
The Ministry of Health of the Russian Federation has developed amendments to the list of medical devices that are exempt from value added tax (VAT). The agency intends to clarify the use of codes for functional and visual diagnostics, probing instruments for medical devices and to add components and accessories to the list of OKDP2 codes. Amendments are planned to be made to the RF Government Resolution No. 1042, which regulates the exemption of medical devices from VAT upon their import and sale. In particular, a new code OKPD2 "Other plastic tubes, hoses and sleeves" will be added to the "probing instruments" position, and an additional code 26.60.12.140 - "Parts and accessories of electrodiagnostic equipment and equipment based on the use of ultraviolet or infrared radiation" will be added to the "treatment devices and apparatus" position. The OKDP2 code "Implants for exoprosthetics, orthopedic fixing systems" will be added to the "treatment devices" position. In the case of lenses, finished and semi-finished products for corrective glasses will be added to the list of benefits, and in the section of technical rehabilitation equipment, in the "clothing for the rehabilitation of disabled people" position, the use of codes will be clarified. In particular, compression hosiery with distributed pressure, such as stockings for patients with varicose veins, will be excluded from this position.
If approved, the amendments will come into force within one month from the date of official publication, but not earlier than the 1st day of the next VAT tax period.
In July 2020, the Government of the Russian Federation obliged the Ministry of Health, the Ministry of Industry and Trade and the Federal Customs Service to annually review the list of medical products exempt from or not subject to VAT, analyzing the application of the list by February 15, and then, if necessary, submitting a proposal to the Cabinet of Ministers to adjust it.
In March 2025, the government withdrew from the State Duma a bill on amendments to the Tax Code, which gives the right to manufacturers of Russian medical products to compensate for the value-added tax on components in the production of medical equipment. The amendment is intended to equalize the position of Russian and foreign vendors who could return VAT on products imported into Russia. The document was submitted to the State Duma in the fall of 2023 and recommended for adoption in the first reading by the relevant committee of the lower house of parliament.
The Ministry of Health has approved a list of medical devices to provide assistance to patients with diabetes
The Ministry of Health of the Russian Federation has approved a list of medical devices and other equipment for equipping regional, inter-district (district) centers providing medical care to patients with carbohydrate metabolism disorders and diabetes. The order was prepared in accordance with the federal project "Fight against diabetes".
The list consists of 27 items - a podiatric chair with power supply, a portable Doppler apparatus, a medical couch, a table for ophthalmological instruments with mains power, a set of trial lenses with trial frames and accessories, an automatic refractometer, a stationary slit lamp with accessories, an electric ophthalmoscope.
In addition, the list includes an automatic perimeter for kinetic, static and special types of perimetry, an automatic tonometer-tonograph, a pachymeter, a retinal camera for fluorescein angiography, an optical coherence tomograph (anterior, posterior), an endothelial microscope, an aberometer, a keratotopograph, a device for ultrasound A-B scanning with a sensor for ultrasound biometry, a complex for EFI studies, an automatic pneumotonometer, an exophthalmometer, a binocular ophthalmoscope for reverse ophthalmoscopy with head fixation, a perimeter, a laser photocoagulator with a green beam complete with a slit lamp, a YAG laser (yttrium-aluminum garnet) complete with a slit lamp, a laser for selective trabeculoplasty, lenses for iridotomy-capsulotomy and a pedicure device.
Market news
Cartel in the supply of medical equipment worth 55 million rubles was found in Bashkiria and Udmurtia
The FAS Administration for the Republic of Bashkortostan stated that BMT-Medtekhnika LLC and Nihao LLC entered into an anticompetitive agreement when supplying medical equipment to state clinics in Bashkiria and Udmurtia at auctions for a total of 55.2 million rubles. An administrative case will be initiated in the near future.
The antimonopoly agency believes that the operators colluded “with the aim of setting and maintaining prices at auctions.” Allegedly, the companies abandoned competition, systematically using a single model of behavior when participating in trading procedures.
Source: https://t.me/vademecum_live/17783
Other
AI has created synthetic models of the heart to treat atrial fibrillation. New technologies will help in personalized treatment
Scientists from Queen Mary University of London have developed a tool based on artificial intelligence (AI) that creates synthetic, but medically accurate models of fibrous heart tissue. These models will help in planning treatment for patients with atrial fibrillation (AF), which may lead to a more personalized approach in medicine.
New registered medical devices
We publish a list of new medical devices registered from 04/18/2025 to 04/25/2025
Link to the list: [see. table in attachment]
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