News Digest 07.03.2024 — 11.03.2024
Regulators
The Ministry of Industry and Trade proposed to label ten new types of medical products
The Ministry of Industry and Trade proposed conducting an experiment on labeling ten new types of medical products. Labeling codes are proposed to be applied to condoms, syringes and tubes, infusion systems, ventilators, incubators for newborns, medical masks, napkins (including disposable ones) and subcutaneous implants for facial contouring in the form of fillers and cosmetic threads, follows from the project government resolution published on the portal regulation.gov.ru.
The experiment will take place from September 1, 2024 to August 31, 2025. The operator of the pilot project will be Center for the Development of Advanced Technologies LLC.
According to the company, the formation of a new list for the labeling experiment took place through the joint efforts of the regulator, public organizations and market participants, including medical institutions. Categories of medical products were assessed, in which there is a high proportion of illegal trafficking, violations, or an additional tool for government control is needed.
Roszdravnadzor will have full access to the traceability of the entire range of goods included in the experiment. This will allow the regulator to assess their sufficiency and staffing of medical institutions, and in the future, block the circulation of those medical products whose quality has been questioned.
Participation in the experiment will be voluntary and free for the industry - the operator will bear all expenses.
Source: https://medvestnik.ru/content/news/Minpromtorg-predlojil-markirovat-10-novyh-tipov-medizdelii.html
Market news
Two medical institutions in the Belgorod region were allocated 182 million rubles for retrofitting
The government will allocate 182 million rubles. for the retrofitting of medical institutions in the Belgorod region, the order was published on the website of the Cabinet of Ministers on March 11. The funds were allocated from the reserve fund as part of the work under the state program “Health Development”.
It is planned to equip two clinics with medical equipment: the Belgorod Regional Clinical Hospital of St. Joasaph and the Belgorod City Clinic. An MRI machine, an angiographic complex, a set of instruments for diagnostics and surgery in otorhinolaryngology, as well as a laser device for otorhinolaryngological operations will be purchased.
A hospital will be built in the Chelyabinsk region for 884 million rubles
The Center for Public Procurement of the Chelyabinsk Region announced a tender for the construction of a regional hospital with a 24-bed hospital in the city of Minyar. The initial maximum contract price is 884.1 million rubles. Funds will be allocated from the federal and regional budgets. The commissioning date for the medical facility is scheduled for December 1, 2025.
Source: https://vademec.ru/news/2024/03/07/v-chelyabinskoy-oblasti-postroyat-bolnitsu-za-884-mln-rubley/
Other
FDA approves first over-the-counter continuous glucose monitoring system
The US Food and Drug Administration (FDA) has approved Stelo, the first continuous blood glucose monitoring (CGM) system approved for over-the-counter use, the regulator said in a press release.
The CGM is a sensor that is pierced through the skin. It monitors blood sugar levels on an ongoing basis and transmits this information to the patient's smartphone every 15 minutes. The device can be used for 15 days, after which it should be replaced.
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