Author Archives: beawire

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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Nowadays the market for biomedical cell products (BMCP or BCP) is a rapidly growing branch of the global economy. This is due to the fact that this type of product provides a fundamentally new approach to the treatment of many diseases: malignant neoplasms, cardiovascular diseases, diseases of the nervous system and musculoskeletal system, as well as diabetes mellitus. BMCP is

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На сегодняшний день рынок биомедицинских клеточных продуктов (БМКП) является быстро развивающейся отраслью глобальной экономики. Это связано с тем, что данный вид продукта обеспечивает принципиально новый подход к лечению многих заболеваний: злокачественных новообразований, сердечно-сосудистых заболеваний, болезней нервной системы и опорно-двигательного аппарата, а также сахарного диабета. БМКП также активно применяются в области эстетической медицины для борьбы с возрастными изменениями кожи. Две коммерческие

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The manufacturer was fined 500 thousand roubles for supplying unregistered medical oxygen to a medical institution in Rostov

During a scheduled inspection the Territorial Division of Roszdravnadzor for Rostov region revealed that for a year Kislorod LLC had been supplying medical oxygen not included in the State Register of Medicines to one of the medical institutions of the region. After examining the materials of the case, the Arbitration Court of Rostov region passed a ruling to institute administrative

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The number of stomatology material samples for biocompatibility studies

In one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials). Current article is about necessary number of stomatology (dental) material samples for toxicological testing. The standard regulated this quantity in Russia is GOST 31576. And its actual version is GOST 31576-2012. The 3rd section of these standards contain the table, regulating the necessary number

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