Toxicology tests for medical devices intended for in vitro diagnostics are to be performed in order to determine any possible harmful effect of a material or device on the human body, caused by a toxicity factor. These tests have to be performed for medical devices intended for immediate contact with the human body, when used as per the intended indications
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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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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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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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A medical device for in vitro diagnostics is any medical device intended by the manufacturer to study samples of human biological material without contact with a patient in separate application or in combination with other medical devices, only for the purpose of obtaining regarding physiological or pathological condition, and (or) fetal development problems, and (or) monitoring therapeutic interventions, and (or)
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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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The reliability and accuracy of the sample results in clinical laboratory tests are influenced by many factors, such as the preanalytical factor, sampling, transportation, storage of samples, as well as the presence of interfering substances in the biomaterial samples. Interfering substances are one of the most common errors in clinical laboratory measurements. The presence of these substances in the samples
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Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG). Autoimmune mechanisms are at the heart of many organo-specific and systemic diseases. These diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, ulcerative colitis and other less known diseases. The resulting autoimmune process is usually chronic and
Read moreSeminar for Korean manufacturers contains information about: how to be prepared for technical and toxicological trials (preclinical trials) during Russian registration? what is main feature? does Russian Government have list of applied standards for medical devices nowadays? how to provide trials of IVD? How registration process is provided and what is the place of trials in this process.
Read moreIn Roszdravnadzor the seminar for domestic producers on the questions of the pre-qualification requirements of WHO to medical products for invitro diagnostics has taken place.
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