News Digest 10.06.2024 — 13.06.2024
Regulators
Rospotrebnadzor has developed a form for assessing a license applicant for disinfection services
Rospotrebnadzor has developed a form of an assessment sheet, according to which an applicant for a license is assessed for the requirements for the provision of disinfection, disinsection and deratization services. The corresponding draft order is at the public discussion stage until June 24.
The assessment sheet proposed for approval must indicate:
- the form of the assessment of the applicant's compliance with licensing requirements;
- the registration number and date of registration of the application for a license;
- the status of the person being assessed (applicant or licensee);
- the name, organizational and legal form, address within the location of the legal entity or full name of an individual entrepreneur and the address of registration at the place of residence;
- OGRN, OGRNIP, registration number of the record of the creation of a legal entity (IP), INN and other documents;
- the address (addresses) of the place of implementation of the licensed type of activity;
- the name of the type of work and services constituting the licensed type of activity;
- location of the assessment of compliance with license requirements with the completion of the assessment sheet;
- details of the decision to conduct the assessment of compliance with the requirements, made by the authorized official of Rospotrebnadzor;
- position and full name of the official of Rospotrebnadzor conducting the assessment of compliance with the requirements and filling out the assessment sheet;
- a list of control questions, the answers to which must indicate compliance (non-compliance) of the license applicant or licensee with the licensing requirements.
If approved, the document will enter into force on September 1 and will be valid until September 1, 2030.
Earlier, Rospotrebnadzor approved the form of the industrial control program, which is necessary for the provision of disinfection, disinsection and deratization services. The corresponding order will enter into force on September 1 and will be valid until September 1, 2030.
Market news
Primorsky Krai to Launch Production of Glucometer Test Strips under Offset Contract
The Primorsky Krai State Procurement Center has summed up the results of the competition for the conclusion of an offset contract for the localization of production of Gmate Life glucometer test strips in the region. The winner was MedTechService LLC, with which a contract worth more than 1.37 billion rubles was concluded, the Pharmaceutical Bulletin reported with reference to data from the state procurement website.
The company has undertaken to create and master the production of reagents, investing at least 300 million rubles in it. From 2025 to 2033, 85 million test strips for Gmate Life analyzers are planned to be purchased under the contract. Already in 2025, 5 million test strips will be delivered, then 10 million annually for eight years. MedTechService launched the Hilart plant for the production of test strips for glucometers in the Irkutsk region in 2018. The company could not obtain a registration certificate from Roszdravnadzor for a year and a half. Immediately after it was issued on August 5, the plant began to participate in tenders. In 2019, the company signed its first government contract.
The situation with the availability of continuous glucose monitoring (CGM) devices for patients with diabetes remains tense in Russia. The issue was raised at a meeting of the head of state with members of the government in September 2023, MV reported. Disruptions in the supply of CGM systems for children arose after the US authorities added components for them manufactured by Medtronic to the list of dual-use products.
A company close to ELS-Med will invest 2 billion rubles in the production of medical equipment near Tula
The Ilmes company has signed a cooperation agreement on the construction of a plant for the production of diagnostic equipment in the Uzlovaya special economic zone (SEZ) in the Tula region. The volume of investments in the project is estimated at 2 billion rubles. Earlier, in 2022, another company close to ELS-Med, Sonder LLC, signed an agreement on the localization of "heavy" medical equipment in the SEZ. The project is in the implementation stage and is in the process of obtaining registration certificates for medical devices.
The new document was signed by Deputy Governor of the Tula Region Sergey Egorov and Executive Director of Ilmes LLC Yulia Kandaurova. The company will be able to take advantage of tax and customs preferences of a SEZ resident. It is expected that 65 jobs will be created at the plant.
According to SPARK-Interfax, Ilmes LLC is 100% owned by Evgeny Khripko, the beneficiary of the distributor MSN and co-owner of the medical equipment production company ELS-Med.
The ELS-Med company became a resident of the Dubna SEZ in the Moscow Region in September 2019. As company representative Sergey Vlasov told Vademecum, the project was founded as an import-substituting production by people from companies that distribute medical equipment. The founders of ELS-Med are Timur Khairulin and Evgeny Khripko. In 2023, the company earned 490 million rubles, net profit amounted to 49.7 million rubles. In December 2021, the production of expert-class ultrasound scanners was localized at the Dubna plant - Russian versions were released under the ELS-500, ELS-500T and ELS-500 Mini brands. After reaching full production capacity, the company expects to occupy up to 10% of the X-ray and ultrasound equipment market in Russia.
In June 2022, an agreement was signed on the establishment of a production facility for medical diagnostic equipment in the Uzlovaya SEZ between representatives of Sonder LLC and the Governor of the Tula Region Alexey Dyumin at the St. Petersburg International Economic Forum. According to SPARK-Interfax, Sonder LLC was registered in May 2022 and belongs to the CEO of the ELS trading house, Layla Sitdikova. The investment volume in the project was estimated at 1.5 billion rubles. The plant plans to assemble 1.5T and 3T MRI, 16, 32, 64, 128 and 256-slice CT, 2- and 3-workstation X-ray machines and mammographs. The plant's capacity will be 50-100 MRI and CT per year, 200 units of each type of X-ray machine and 400 mammographs. In addition, the plant will produce high- and expert-class stationary and portable ultrasound machines - up to 2 thousand units per year of each type, as well as about 5 thousand expert-class ventilators. The project is currently in the implementation stage, localization of production and obtaining registration certificates for the equipment.
The first specialized cardio-oncology center will be created in Moscow
The Moscow Department of Health has approved an order to organize the City Cardio-Oncology Center on the basis of the S.S. Yudin City Clinical Hospital. It should be formed by June 15, 2024. The center will unite the consultative and diagnostic department, the functional diagnostics department, the expert department and the organizational and methodological office of the hospital.
It is planned that the center will employ 12 cardiologists in the consultative and diagnostic department, eight specialists in functional diagnostics in the specialized department and at least eight cardiologists in the expert department.
Other
Moscow outpatient clinics to be equipped with psychological relief rooms for medical staff
Psychological relief rooms have opened in 220 Moscow outpatient clinics, the mayor's office press service reported. Another 180 primary health care institutions in the city will be equipped with such rooms later, said Deputy Mayor of the capital Anastasia Rakova.
It is planned that this will help prevent professional burnout and reduce stress among medical workers. In the relief rooms, medical specialists can relax, rest in a massage chair, watch TV, listen to music, or "just enjoy the silence before and after the work day, as well as during technological breaks and lunch."
AI service for detecting thoracic aortic aneurysm registered
IRA Labs received the registration certificate for the Multi-IRA product. This is the 33rd registered MI with AI, and the first for analyzing CT scans of abdominal organs and detecting thoracic aortic aneurysm.
Source: https://t.me/delotom/417
Newly registered medical devices
We publish a list of new medical devices registered from 06/07/2024 to 06/13/2024
Link to the list: [see table in the attachment]
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