Tag Archives: Head

What is EDC and what does it have to do with cosmetics?

EDC (Endocrine disrupting chemicals) – chemicals that destroy the endocrine system (a system of glands that make hormones). Currently, a team of European Union experts classified approximately 150 substances as EDCs. Surprisingly, representatives of this group of substances can still be part of food, plastic packaging and cosmetic products. What compounds are included in EDC? How dangerous are they? And

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What are weight-loss dietary supplements and what do they do?  

The proven ways to lose weight are cutting calories, eating healthful foods and being physically active.  But making these lifestyle changes isn’t easy. In this regard, eating weight loss supplements is a common way to combat excess weight. This article will consider the most common ingredients included in the composition of dietary supplements, as well as their benefits and harms.

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Complicated medical device

We face both “complex” and “simple” products in the course of work. Let’s clarify what we mean by these concepts. A “complex” product is: – a product incorporating many elements, each of which requires a detailed description in the technical and operational documentation; – highly engineered product; – a product in compliance with international safety standards, possibly even widely distributed

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Marketing authorization of Medical Devices for aviation in Russia

Marketing authorization of Medical Devices (MD) for aviation and the registration procedure for “conventional” medical devices are different.  The main difference is the special aspects of the technical tests. First of all, the types of medical devices should be determined that can be used on aircraft. The list of medical devices and medicinal products that can be provided to civil

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The first license for production of BMСP was obtained.

The first license for production of BMСP was obtained. Licensing of BMСP production was one of the key problems in bringing such products to the Russian market. We have published several articles covering the requirements for the applicant of the license (https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/), as well as the success of some companies in licensing the production of BMСP (https://beawire.com/ru/2019/04/08/bmcp-problems-and-prospects-of-development-in-russia/). According to the

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The procedure for entering into civil circulation of medicines for medical use.

Since November 2019, the Resolution of the Government of the Russian Federation No. 1510, which defines the new order of entry of the drugs into civil circulation, came into force. Previously, drug release required obtaining a declaration of conformity or certificate of conformity. The batch of the drug was checked for compliance with the quality indicators specified in the regulatory

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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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