List of type codes dated June 28, 2022 based on the results of a meeting of the interdepartmental commission on the formation of a list of types of medical devices subject to circulation in accordance with the Peculiarities of circulation, including state registration features of medical devices in the event of their defectiveness or the risk of defectiveness in connection
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Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our comparison below: No. Item National system EAEU 1 Main document Decree of the Government of the Russian Federation No. 135 dated 09.02.2022 “On approval of the Rules for arranging and conducting inspections of the production
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National registration system for medical devices in Russia (general registration by Order 1416 from 27/12/2012) is prolongated until the end of 2022 as well as national systems of other Members
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With the entry into force of the EAEU registration rules, the classification of drugs has changed significantly, as we wrote in the article “NOMENCLATURE OF MEDICINES WITHIN THE FRAMEWORK OF REGISTRATION ACCORDING TO THE RULES OF THE EAEU”. (https://beawire.com/ru/2020/09/16/nomenclature-of-medicines-within-the-framework-of-registration-according-to-the-rules-of-the-eaeu/). However, the existing classification does not quite clearly describe such category of drugs as FDC-FPP. It is worth noting that its
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When classifying devices as medical in the Russian Federation, the Federal Service for Overseeing Healthcare (hereinafter Roszdravnadzor) is guided primarily by the definition of medical devices as specified in Clause 1 of Article 38 of Federal Law No. 323-FZ dated 21 November 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter Federal Law No. 323-FZ) and in Clause 2 of Decree No. 1416
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Fast track regulation (so called, COVID-19 fast track registration) is prolongated (list of products under regulation). Order of Russian Government 430 from 3rd of April 2020 in action until 2025 (amendments are done). Link to Government source: http://government.ru/news/44084/#
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In early October, the State Register of Medicines (GRLS) revealed the suspension of a number of ranitidine drugs intended to treat peptic ulcer disease. The reason for the mass suspension was the conclusion of FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation which was based on information on the presence
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The covid-19 pandemic was a catastrophe of the 21st century, not only for humanity, but for planet Earth as a whole. Due to the epidemiological situation, people in many countries are still obliged to observe a mask regime. As a result, in Russia alone, about 10 million disposable masks are now being sent to the trash every day, and it
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Humanity now uses a huge number of biotech drugs without thinking about their origin and production process. Such drugs include, for example, insulin, hormonal drugs, vaccines, etc. Biotechnology (BT) drugs account for 29% of sales in Russia. BT drugs are expected to account for 35% by 2026. What does a “biotech” drug mean? What is its difference from “chemical” and
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Often, food advertisements have the following phrases: “enriched with probiotic” or “contains prebiotics.” These two words differ in only one letter, but is there any meaning behind this different spelling? According to WHO definition probiotics are nonpathogenic to human bacteria that have antagonistic activity against pathogenic and opportunistic bacteria and restoring normal microflora. It appears from the definition that probiotics
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