News Digest 08.07.2024 — 10.07.2024
Regulators
Roszdravnadzor has cancelled the regulations for accepting notifications in the field of circulation of medical devices
Roszdravnadzor has declared order No. 3239 of 04/25/2019 on the approval of the administrative regulations for accepting and recording notifications about the start of activities in the field of circulation of medical devices invalid. The corresponding order No. 3430 of 06/10/2024 was published.
The cancelled regulations did not take into account the clinical trials of medical devices, their production, installation, adjustment, use, operation (including maintenance), and repair.
Earlier, the government approved Resolution No. 219 of 02/28/2024, which updated the rules for submitting notifications about the start of certain types of activities, including the circulation of medical devices. According to it, notifications must now be submitted to each new address. The document can also be submitted through the public services portal. The submitted notifications are recorded in a single registry of notifications on the platform of the single registry of types of control.
Since August 8, 2023, Roszdravnadzor, as part of simplifying control, introduced a notification procedure for the import of unregistered medical products for their registration. Now, developers of medical products for registration in the country must send notifications to the service about the import of specific samples of medical products for their registration.
The service also reported that it is no longer necessary to obtain permits stipulated by the procedure for importing medical products for the purposes of state registration (Order of the Ministry of Health of Russia No. 661n dated June 30, 2020).
Liability for causing harm when using AI solutions has been introduced
Lawmakers have provided for liability for causing harm to the life, health or property of a person or the property of a legal entity when implementing an experimental legal regime (ELR) using solutions developed using artificial intelligence (AI) technologies. Amendments have been made to the Federal Law "On experimental legal regimes in the field of digital innovation in the Russian Federation" (the document is available on "MV").
The federal law has been supplemented with an article regulating the consideration of cases of causing such harm. To this end, the regulatory body must create a commission to establish all the circumstances, including the scope and nature of the damage, including technical (technological) failures and (or) errors made during the development and implementation of these technologies, the actions (inactions) of persons that caused or could have caused such damage. Based on the commission's findings, a decision will be made on taking measures to minimize and (or) eliminate the consequences of causing damage and preventing similar cases; on changing the experimental legal regime; suspending the status of the EPR subject.
The amendments to the federal law also provide for civil liability insurance of participants in the experimental legal regime for causing harm to life, health or property of other persons, including as a result of using AI solutions, requirements for the terms of such insurance, including the minimum amount of the insured amount, a list of insurance risks and insured events. To this end, the EPR subject will have to maintain a register of persons who have entered into legal relations with it. In addition, the law provides for the possibility of extending the experimental legal regime for up to three years simultaneously with changing its terms, and also establishes the obligation of the government to submit an annual state report to the chambers of the Federal Assembly on the activities carried out within the framework of the experimental legal regimes.
The law will come into force 180 days after its official publication.
Market news
A polyclinic will be built in the Odintsovsky district of the Moscow region for 1.9 billion
The Territorial Development Fund has announced a competition for the construction of a mixed-type polyclinic in the village of Trekhgorka, Odintsovsky district, Moscow region. The starting price of the contract is 1.86 billion rubles. The region will allocate 30% of the total amount, 70% will be received from the federal budget.
The building with a total area of 9,905 sq. m are planned three buildings - six-story, eight-story and two-story with passages. The capacity of the medical institution will be 500 visits per shift. Day and round-the-clock hospitals are designed for 50 beds.
Common areas for the departments include two floors: on the first floor it is planned to locate the reception, archive and temporary storage rooms for medical waste of classes G, B, V, on the second - rooms for rehabilitation treatment for visitors, sanitary and service purposes.
Six floors will be built for the children's department. On the first floor there is an ambulance station, as well as a box for cars, emergency care and X-ray diagnostics rooms, on the second - an office for telemedicine consultations, departments radiation diagnostics, a conference hall for 50 seats.
On the third floor there will be offices of district doctors and pediatricians, ultrasound and ECG, and vaccination. In addition, the building will house offices of a traumatologist, dentists (with auxiliary rooms), a pediatric surgeon with a dressing room, a neurologist, an endocrinologist and ophthalmologist, and a urologist-andrologist. The medical institution also plans to have physiotherapy and massage rooms, and a therapeutic exercise room.
The eight-story adult department will include offices of the doctor on duty, an epidemiologist, a traumatologist-orthopedist, and a physiotherapist. The third floor will house vision protection, ECG, ultrasound, encephalogram and spirography, as well as mammography and X-ray fluorography rooms. On the fifth floor there will be two day hospital wards with six beds. The department also plans to have a foyer with a nurse's station, seven wards for a day hospital with 22 beds, a doctor's office, and dentists' offices.
The clinic is planned to be built on the site of an unfinished facility built in 2015. In October 2014, it was reported that the company "SU-55" was supposed to build a clinic with an ambulance substation under a contract, but was unable to complete the work.
In March 2017, the Odintsovo District Administration promised to begin work on the construction of the institution together with the Urban Group company within a month. In April 2022, Region-Proekt LLC announced a tender for the design and survey work for the same facility. The initial contract price was 27.9 million rubles. The winner of the competition was not specified.
Mosoblarchitecture again announced the construction of the clinic in December 2023. At that time, the project implementation dates were not scheduled.
RNC Pharma presented data on inflation in the retail market of medical devices based on the results of May
Prices for medical equipment and medical devices in the Russian retail market, including online sales, increased by 6.2% in 2023 compared to 2022 figures. At the same time, inflation rates varied significantly in different categories of medical equipment. RNC Pharma experts analyzed sales of glucometers, test strips for glucometers, nebulizers, medical thermometers and tonometers in a new review.
The price index for the reporting period never fell below zero. However, for other product groups, negative inflation rates were absolutely normal last year, analysts note. Since June 2023, the price index in the glucometer category has been significantly increasing and reached a maximum of 90.6% in April 2024. By the end of May 2024, inflation had dropped to 90.4% (Fig. 1). For most of 2023, the price index level in the online channel was significantly higher than in retail. In 2024, on the contrary, prices on marketplaces increased at a slower rate than offline. By the end of five months, the price index for glucometers was 63.5%, while in the offline channel, the inflation rate in the same period exceeded 72%. In total, in both channels, by the end of January - May 2024, the price index in this category was recorded at 78.4%. At the same time, prices for test strips for glucometers in 2023, on the contrary, decreased. This trend in this market (including online) was observed from April last year to February this year. In March 2024, the inflation rate began to increase again, and by May it reached 5.8%. In total, based on the results of five months, the price index on the market as a whole was 1.8%. At the same time, in the e-com channel, the indicator was higher - 2.6%.
Other
A device for safe thyroid surgery has been created at the NMIC of Endocrinology
Specialists from the Endocrine Biophotonics Laboratory of the NMIC of Endocrinology have developed a device for searching, identifying and determining the viability of the parathyroid glands (PTG) for safe thyroid surgery, based on the physical principles of biophotonics. It is planned to conduct clinical trials of the medical device with the participation of volunteer patients to confirm its effectiveness and safety, the press service of the center reported.
Every year, several tens of thousands of operations on the thyroid gland are performed in Russia. One of the most common complications in such interventions is hypoparathyroidism due to accidental removal, mechanical damage or devascularization of the parathyroid glands - endocrine organs that produce parathyroid hormone, which is actively involved in maintaining adequate calcium levels in the body.
The parathyroid glands are only a few millimeters in size and are located in adipose tissue, which makes it difficult to visually detect them during surgery. Previous studies have shown that the parathyroid glands have natural autofluorescence in the near infrared spectral range compared to surrounding tissues. The operation of the device is based on this property. The device helps not only to identify the parathyroid glands during surgery, but also to determine their viability. The accuracy of intraoperative identification of the parathyroid glands reaches 92%.
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