News Digest 24.01.2024 — 26.01.2024
Regulators
Roszdravnadzor has updated the checklist for licensing the maintenance of medical devices
Roszdravnadzor published an order according to which the checklist for licensing the maintenance of medical devices has been updated. The supervisory authority excluded one of the control questions from the form of the assessment sheet - about attics and basements.
Roszdravnadzor has updated the checklist for licensing the technical maintenance of medical devices. The corresponding order No. 9379 dated December 19, 2023 was published the day before on the legal information portal. The supervisory authority developed the document in November 2023.
According to the document, one of the control questions has been excluded, the answers to which should indicate compliance (non-compliance) with licensing requirements. We are talking about the question “Does the license applicant, licensee use attics, technical, basement and ground floors, undergrounds, ventilation chambers and other technical premises to carry out the licensed type of activity for the maintenance of medical devices.”
Fire safety requirements are excluded from the checklist for servicing medical equipment
Roszdravnadzor excluded from the assessment sheet for compliance with licensing requirements for the maintenance of medical devices the item that determines compliance with fire safety standards. The changes were approved by departmental order No. 9379 dated December 19, 2023 (registered by the Ministry of Justice on January 24, 2024).
Market news
The shareholder of VSMPO-Avisma intends to invest in the production of titanium medical products in Moscow
The Industrial Investments company of the main shareholder of the Russian industrial giant VSMPO-Avisma, Mikhail Shelkov, established the Medical Titan LLC (Medti) company in the capital at the end of December 2023. The main specialization is the production of medical devices. Details of the project are not disclosed; the company's authorized capital is 1 million rubles.
Russian chemists proposed patches and films instead of injections and tablets
Institute of Fine Chemical Technologies named after. Lomonosov RTU MIREA presented two new products that make it easier to administer vaccines and take medications, Izvestia reports. The institute's specialists approached the process of administering vaccines in a new way - they developed a patch equipped with pyramids, 0.6 mm high, which act as needles. These pyramids pass through the stratum corneum of the skin, but do not touch the nerve endings, and therefore the procedure is painless for the patient. Having penetrated the skin, they dissolve over a certain time, depending on the drug administered. University specialists believe that patches equipped with “pyramids” will replace the usual injections. These patches can be used for different vaccines. For some, this form of drug administration allows the use of a lower dosage of antigens than with the injection method. The proposed method is psychologically more comfortable, especially for children.
Other
High-resolution ultrasound for regenerative medicine
At the Institute of Biochemical Physics named after. N.M. Emanuel RAS, together with colleagues, developed a new ultrasound imaging method to study the degradation of PLGA polymers in vivo. The use of a high-frequency acoustic microscope has made it possible to non-invasively examine small laboratory animals and visualize in detail the processes inside tissues. • The results of the work were published in the European Polymer Journal, details are given in the article “Sound that Sees” in the publication “Kommersant” (“L-Science”) authored by senior researcher. IBCP RAS, Ph.D. Egor Morokov. and The study showed asynchronous degradation of PLGA polymer in vitro and in vivo, with a lag of two weeks for implanted samples, which is associated with different access to fluid and formation of a fibrous capsule.
Source: https://www.sciencedirect.com/science/article/abs/pii/S0014305723004317?via%3Dihub
New registered medical devices
We publish a list of new medical devices registered from 01/19/2024 to 01/26/2024
Link to the list: [see. table in attachment]
News
