Category Archives: Beawire

Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 1113n).

In the previous article devoted to the update regarding safety monitoring, we considered Order 980n “On Approval of the Procedure for Safety Monitoring of Medical Devices” . In this small review, we would like to refer to Order 1113n, which will replace the Order 12n on January 1, 2021 and will be valid until January 1, 2027. Before talking about

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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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In vitro diagnosis of autoimmune diseases

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

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Orphan diseases

According to the All-Russian Society of Orphan Diseases, about 30 million patients with rare diseases were registered in the European Union. This means that every 15th European suffers from one or another orphan disease. The figures are impressive, given that the synonym for orphan diseases is “rare diseases”. Federal Law 323 states that orphan disease is a disease the prevalence

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CAR-T therapy

 In the section devoted to biomedical cell products, much attention was paid mainly to the legal aspects of the circulation of this type of product, as well as to the basic procedures that make up the life cycle of BMCP. However, this article is devoted directly to BMCP – the newest and promising method of treatment of cancer, in particular

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Telemedicine in Russia – review

Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for connection healthcare specialists and patients. We started special topic about this: Why telemedicine is important as healthcare service? How it is regulated by government? Which products is considered to be medical devices for telemedicine? This is not full range of

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Medical device labeling

Today we speak about some easy but necessary rules in Russia – labeling, marking of medical devices must comply with in order to medical device could be registered in Russian Federation. Should be noticed, that all the labeling rules (except the electrotechnical symbols) are regulated by 3 standards: GOST R 50444, GOST R ISO 15223 and GOST 14192. The last

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