News Digest 07.03.2025 — 14.03.2025
Regulators
In 2024, Roszdravnadzor conducted 559 unscheduled inspections in the field of circulation of medical devices
Roszdravnadzor presented a report on state control in the field of circulation of medical devices for 2024. The number of unscheduled control (supervisory) activities was 559, including random control (374), inspection visit (37), documentary verification (20), on-site inspection (128). Based on the results of the activities, the regulator carried out 3,008 control actions. Source:
The procedure for maintaining the register of operators of the medical waste disposal market has been presented
The Union of Medical Workers of the Chuvash Republic has posted for public discussion the draft Rules for posting information on persons providing services for the transportation and disinfection of medical waste, as well as on their facilities, on the official websites of territorial departments of Rospotrebnadzor, prepared by the Ministry of Health of the Russian Federation. The document also includes a list of data on such organizations, which the regulator will enter into the register. If adopted, the government decree will be valid from September 1, 2026 to September 1, 2032.
The Ministry of Health has finalized the requirements for the transportation and disinfection of medical waste
The Ministry of Health of the Russian Federation has updated the draft requirements for the Procedure for the provision of services for the transportation and disposal of medical waste of classes "B", "C" and "G" (with the exception of waste similar in composition to extremely and highly hazardous waste). During the discussion of the first version of the document, the developers received 11 proposals, of which they fully took into account eight and partially one. The thematic order was prepared in connection with the enshrining in legislation in August 2024 of the terms "handling of medical waste", their "accumulation", "disinfection" and "neutralization". The requirements currently being developed by the Ministry of Health, if approved, will come into force on September 1, 2026 and will be valid until August 2032.
The rules for forming the initial maximum contract price (IMCP) for public procurement of medical devices have been updated since March 11
Changes regarding the procedure for determining the initial maximum contract price (IMCP) for the procurement of medical devices came into force on March 11, 2025. Thus, to determine the average weighted price, customers will be able to include in the calculation contracts concluded in neighboring regions or in entities located within the same federal district. If no suitable contracts are found, at least three prices of contracts signed within three years and executed in any other region of the Russian Federation may be taken into account during the procurement.
Market news
The Agency for Technological Development has issued 2 billion rubles for the development of medical devices
The Agency for Technological Development (ATD) has increased its portfolio of projects in the field of medical devices and rehabilitation, having issued a total of 2 billion rubles in the form of grants for reverse engineering and component programs. In 2025, it is planned to further expand the number of supported projects.
This was announced by Vladimir Pastukhov, CEO of the ADT. According to him, in 2025 the agency will launch new competitions for the development of medical components.
Among the projects supported by ATP in the field of medical devices is the reverse engineering of a hip joint endoprosthesis and a polycentric knee module, which was implemented by the company "Anatomika". The project has already entered the final stage. Currently, the facilities are being prepared for the launch of their serial production. "Gemogenix" developed an electromagnetic valve for automatic blood extraction, "Reabilitik" performed the reverse engineering of a control unit for medical beds, the company "Karfidov Lab" has advanced in the development of motor-reducers for biomechanical prostheses. In addition, the agency issued grants for the creation of Russian bone cement, a two-channel neuromodulator, a bone marrow biopsy needle, a bone vibrator for a hearing aid, a two-channel neuromodulator necessary to minimize phantom pain in the wounded, and other projects. In February 2022, the Russian Government established grants of up to 100 million rubles for the development of design documentation for key components of various equipment, including medical equipment. Grants can compensate up to 100% of the cost of expenses. The terms of support are defined by government decrees No. 208 of February 18, 2022 and No. 522 of March 31, 2022. The ANO "Agency for Technological Development" has been appointed as the grant distribution provider. The support measure is designed to localize the production of important products and increase the technological independence Russia in critically needed components for key sectors - oil and gas, energy, heavy engineering, machine tool, medical, chemical industries.
Russian manufacturers and legal entities with a foreign ownership share of no more than 50%, no debts or outstanding penalties, and not in the process of reorganization or liquidation can apply for grants. The maximum grant amount will not exceed 100 million rubles, it will be provided for a two-year period under a special agreement, under which compensation for up to 80% of the costs of paying for design documentation development services is possible.
In total, the government planned to allocate at least 3.6 billion rubles for grants from 2022 to 2024. In 2022, 108 reverse engineering projects were financed, the average size of one grant was 36.5 million rubles. In July 2023, the government allocated another 2 billion rubles for grants to create design documentation for domestic production of components, including for the needs of the pharmaceutical and medical industries.
ANO "Agency for Technological Development" was founded in 2016 as a development institute of the VEB.RF group, subordinate to the Ministry of Industry and Trade of Russia. The company's financial indicators are not disclosed.
The Vice-Rector of PIMU is suspected of fraud in the purchase of medical equipment
The Investigative Committee of the Russian Federation for the Nizhny Novgorod Region has opened a criminal case on suspicion of fraud in the purchase of medical equipment for rehabilitation by employees of the Privolzhsky Research Medical University (PIMU) of the Ministry of Health of the Russian Federation for a total of 7 million rubles. The first vice-rector, the head of the contract service of PIMU and the head of the distributor have been detained.
Rostec to invest 120 million rubles in the Center for High-Tech Prosthetics in Arkhangelsk
The clinic will become a branch of the Center for Innovative Technologies in Orthopedics (CITO) of the Rostec state corporation and will specialize in the production of high-tech prostheses, prosthetics and rehabilitation of patients, including participants of the SVO from the Arkhangelsk region and neighboring regions of the Northwestern Federal District. The center's capacity will be 170 beds, in total it will be able to accept up to 3 thousand patients per year. The volume of investment in the project is estimated at 120 million rubles.
It is assumed that the center will be created on the basis of the Arkhangelsk hospital for war veterans. It will manufacture high-tech prostheses for military personnel, conduct rehabilitation and train patients in the use of prostheses. The medical facility will also provide maintenance and repair of the supplied products.
The structure of the prosthetics center will include six departments. In the therapeutic department, military personnel will be able to receive inpatient treatment, as well as undergo examination to register a disability. Palliative beds will be located in the neurology department. In addition, patients will have access to preventive examinations, consultations with specialist doctors, diagnostic examinations and high-tech medical care.
Currently, the regional administration is carrying out repairs in the premises provided for the center. The total funding for the project is more than 120 million rubles. The opening of the prosthetics center is scheduled for the third quarter of 2025. Patients will be able to receive primary and repeated prosthetics every two years.
Specialists from Sechenov University and ITEB raised 135 million rubles for the development of implants
Junior research fellow at the Institute of Cluster Oncology of the First Moscow State Medical University named after I.M. Sechenov Mark Gabriyanchik and employees of the Institute of Theoretical and Experimental Biophysics (ITEB) of the Russian Academy of Sciences Igor Kanev and Olga Antonova received 135 million rubles from Axiopharm to implement the Neurograft project to develop implants (conduits) for the restoration of peripheral nerves after injuries based on nylon nanofibers. The funds will be used to register the medical device and open production at the Neuroconduit company (a subsidiary of Axiopharm). The new product is planned to enter the Russian market in 2027, and three years are allocated for the project implementation.
Other
A man in Sydney lived with a metal heart for 105 days
In early February, a 40-year-old Australian became the first person in the world to be discharged from the hospital with a heart made of metal, Science Alert reports.
For 105 days, a titanium pump the size of a fist “beat” in the patient’s chest and pumped blood into the man’s lungs while he was doing his usual business.
On March 6, a donor heart finally arrived and the titanium organ was replaced with a real one.
With his real heart, the man could only walk 10-15 meters without experiencing shortness of breath. Doctors say the patient would have died if he had not received the titanium organ in time.
According to the surgeon operating on the patient, “over the next decade, we will see how the artificial heart will become an alternative for patients who cannot wait for a donor heart or when one is simply not available”
Source: https://t.me/medicalksu/5556
New registered medical devices
We publish a list of new medical devices registered from 03.07.2025 to 03.14.2025
Link to the list: [see table in the attachment]
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