News Digest 16.02.2024 — 19.02.2024
Regulators
Roszdravnadzor has updated the regulations for obtaining permits for the export of medical equipment
Roszdravnadzor has re-approved the procedure for issuing permits for the export of medical equipment from Russia. The previously effective order No. 2744 dated May 2, 2023, became invalid at the end of last year. The export of medical equipment has been limited since March 2022; previously the measure was extended until December 31, 2025.
The new version of the regulations concerns medical equipment, the export of which is limited by Decree of the Government of the Russian Federation No. 312 of March 9, 2022.
To export medical equipment, the applicant must submit an application to Roszdravnadzor in paper form or through the department’s AIS indicating information about the applicant, model, characteristics of the medical equipment, and registration dossier data. The application must be accompanied by information about the recipient, the purpose of export, transit countries and an agreement for the supply of medical equipment.
The package of documents will include information confirming the absence of a critical shortage of medical products in Russia. The regulator must examine the documents within five working days; if there is a suspicion of a critical shortage of goods, it can extend the consideration of the application for up to 15 days.
Roszdravnadzor will issue an export permit separately for each shipment in one contract. The regulation will be valid until December 31, 2025.
A temporary ban on the export of medical equipment produced in countries that have decided to introduce “restrictive measures of an economic nature” against Russia, and previously imported from the territory of such countries, was introduced in March 2022. The rules and list of medical equipment are regulated by relevant government regulations No. 311 and No. 312.
In November 2022, the Russian Government extended until December 31, 2023 the restriction on the export of medical equipment abroad. The list of products and equipment compiled in the spring of 2022 has been left unchanged; the export of products is limited to all countries, with the exception of the states of the Eurasian Economic Union.
At the end of December 2023, the Cabinet of Ministers extended the framework ban on the export of medical products from the country until December 31, 2025. The new version of the regulations provided an exception for samples of medical devices previously imported into Russia for the state registration procedure. It became possible to export them subject to the provision of documents verified by Roszdravnadzor and confirming the results of tests or studies of medical devices during the registration procedure.
Market news
Construction of a plant for the production of “smart” syringes has resumed in Astrakhan
In the Astrakhan region, the construction of a plant for the production of medical devices, which was frozen even before the COVID-19 pandemic due to a lack of funds, is being resumed, local publication Astrakhan 24 reported. We are talking about the company "Medintech". Production is planned to start in 2025.
The plant will produce “smart” auto-disable syringes. Their feature, as the manufacturer explained, is that the needle is automatically retracted into the syringe after use, which avoids accidental injuries and infections. The project was estimated at 800 million rubles. with a capacity of 200 million syringes per year.
A clinic with a PET/CT center and a cyclotron will appear in Syktyvkar for 10 billion rubles
Deputy Chairman of the Government of the Komi Republic Anton Vinogradov spoke about the development of a public-private project to build a clinic in Lesozavod (Syktyvkar microdistrict) with an approximate cost of 10 billion rubles. The multidisciplinary medical center will have a PET/CT center and a cyclotron for the production of radiopharmaceuticals. Now the regional authorities, together with an unnamed investor, are selecting a site for construction and developing design and estimate documentation.
In the Perm Territory, the removal of medical waste will be centralized for 277 million rubles
The authorities of the Perm region have announced an auction to find a contractor for the removal of class B and C medical waste from regional medical institutions. In total, the contract provides for servicing 76 clinics at more than 130 addresses. The initial maximum contract price is set at 276.8 million rubles.
Other
Look at it from all sides. The developer presented an application with a 3-D heart for Apple Vision Pro
3D medical animation company Anima Res says the Insight Heart app for Apple Vision Pro will make learning about the heart more fun for medical students and consumers alike.
The 3-D heart image can be controlled using gestures or voice. The high-resolution projection can be rotated and zoomed while monitoring your heartbeat in real time. The developers also added “impressive” visual effects for myocardial infarction, arterial hypertension and atrial fibrillation.
Source: https://t.me/vademecum_live/13144
Samsung Electronics gets approval for sleep apnea detection feature for smartwatches
This order was issued by the US Food and Drug Administration (FDA). The regulator classified the new technology as a Class II product (products the use of which may cause harm to health) under the general name “over-the-counter sleep apnea risk assessment device.” FDA approval is characterized as De Novo, meaning approval for a first-of-its-kind product. This means that in the future, manufacturers of similar devices will have to prove that their product is no more dangerous than Samsung's.
According to Samsung, the function will be used in the Galaxy Watch series. With its help, users over 22 years of age will be able to detect signs of moderate to severe obstructive sleep apnea over a two-day period of wearing the gadget.
Medtechdive emphasizes that the FDA's decision will allow Samsung to compete with Apple in the healthcare market.
In 2023, Bloomberg wrote that Apple planned to seriously expand the list of functions in its devices that are responsible for user health in 2024. Thus, the company wanted to add apnea detection and high blood pressure detection functions to the Apple Watch, a feature that turns headphones into over-the-counter hearing aids to AirPods, and to develop apps for anxiety relief and training for the recently released Vision Pro glasses. Also, according to the publication, Apple is creating a digital paid service to provide users with individual recommendations on maintaining health.
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