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Immunochemiluminescent analysis as a diagnostic method

Currently, there are many models of automatic analyzers that differ in the method used to detect the desired substance. The main analysis methods used are: – radioimmunological (RIA); – enzyme-linked immunosorbent assay (ELISA); – Immunofluorescence; – immunochemiluminescent; – immunochromatographic; – isoserological. Let us consider in more detail immunochemiluminescent analysis. Immunochemiluminescent analysis is based on the enzyme immunoassay. The principle of

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Features of increasing the shelf life of a medical device in case of making amendments to the registration documents

Introduction The shelf life of a medical device determines the period during which the product retains its functional properties and technical specifications established by the manufacturer. After the state registration of a medical device in the territory of the Russian Federation, the established value of the shelf life can be changed in accordance with the Decree of the Government of

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Free consultations (products intended to be used for coronavirus infection diagnostics)

Since March 20, 2020, due to the need to take measures for the non-proliferation of the Coronavirus infection (2019-nCoV), the Federal Service for Surveillance in the Sphere of Health of the Russian Federation (Roszdravnadzor or RZN) introduces special rules. These rules concern consultations about the registration of medical devices intended for the diagnosis of coronavirus infection (consultations in accordance with

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Cosmeceuticals: medicinal products or perfumery and cosmetic products?

Cosmeceuticals (active cosmetics, therapeutic cosmetics) are a category of goods at the junction of medicines and cosmetic products. Cosmeceuticals include various biologically active substances that are not medicinal in certain concentrations. Cosmeceuticals have functional, measurable therapeutic and preventive properties. This is what distinguishes them from products strictly cosmetic. The term “cosmeceuticals” was proposed by Dr. Albert Kligman in 1984 while

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Technical testing of medical devices for in vitro diagnostics

According to the Government of the Russian Federation decree dated 27 December 2012 No. 1416 “On the approval of the rules state registration of medical devices” the term “technical testing” is defined as the testing to determine whether the characteristics (properties) of the medical device meet the requirements of the regulatory, technical and operational documentation of the producer (manufacturer) and

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Urgent registration process for Covid-19 tests is approved by Government

  Order of Russian Government 430 from 03th of April 2020 was published yesterday (06th of April 2020), what is inside: list of products intended to be used in special conditions (emergency, martial law and so on). In this list – IVD test for COVID-19, thermometers, artificial ventilator apparatus; registration certificate is issued on the base on series/LOTs of medical

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About us

Company BW, LLC is consulting agency for medical device and IVD product registration. Every day we develop technical documentation, which is compliant to Russian regulations and requirements. Our team supports whole cycle of registration from translation to sample import and testing arrangements. For each registration process are involved up to 7 specialists, each of the specialist is in charge of

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COVID-19. Are there any effective medicinal products?

Since December 2019, the world has been struggling with a new infectious disease COVID-19 (COrona VIrus Disease 2019). This disease is caused by a virus belonging to the Coronaviridae family. The family includes two subfamilies and five genera which bring together more than 10 species that cause lesions of respiratory organs, gastrointestinal tract, nervous system in humans and animals. On

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Fast track registration for products from special list

Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products: medical devices with 1 risk class are included in this list (for example, gloves), “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate

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