Who is a holder of registration certificate?
About holder and AR
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Labeling of active medical devices
In one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration in Russia. Today we present symbols, that must contain label of active medical devices. They are presented in the Table 1. Table 1 – Necessary symbols Power source parameters 1. Power (I or P) Consuming current or power GOST R
Read moreCMIKEE seminar 17.04.2018 about EAC MED
Main information from yesterday seminar provided by FGBU CMIKEE about EAC MED mark
Read moreMedical 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
Read moreSPRS-therapy
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
Read moreRussian manufacturer CEO received criminal term
Criminal term for manufacture and distribution of an unregistered medical device
Read moreThe 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
Read moreRoszdravnadzor’s involvement in launching a project to organise the quality control and safety of medical activities in the Republic of North Ossetia-Alania
A project to improve the quality of work of healthcare organisations has been launched in the Republic of North Ossetia-Alania.
Read moreThe 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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