Category Archives: medicaldevices

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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Lasers used in cosmetology

The invention of the laser became one of the most important and significant achievements of the twentieth century. Currently laser technologies are used in almost all spheres of life: science, armaments, industry, etc. Lasers are also widely used in medicine, one of the areas of which is cosmetology. A laser is a device that converts pumping energy (light, electrical, thermal,

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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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Triclosan in the composition of medical products

Not so long ago on our site there were published several articles devoted to the most sensational categories of substances, which are often included in cosmetics and medicines, as well as in medical devices and raise disputes among consumers, manufacturers, environmentalists and other communities. (Read more about this in the articles about parabens and silicons). Triclozan is also the subject

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Medical devices that include components of animal origin

 An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs as part of MD have been published more than once (here and here). However, in addition to medicinal substances, various components of animal origin can be included in MD. Product overview Among the MD, which

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Medical devices and telemedicine

After implementation of Federal Law, No 242-FZ dated 07.29.2017 “On the implementation of changes in certain legislative acts of the Russian Federation regarding the application of information technologies in healthcare” (also known as “the Telemedicine Act”), the question may emerge (and for many it has long since emerged): what is the proper definition for the term “telemedicinal device”. There are

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Special aspects of import of medical devices, which include precursors of narcotic substances

In the medical device market, there is a large number of products that contain various chemicals in the composition – active pharmaceutical substances, ancillary substances, as well as precursors of narcotic substances. This article is devoted to the peculiarities of the import of such devices. What are narcotic substances and their precursors? According to Federal Law No. 3 “On Narcotic

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Import of medical device samples for the registration on the territory of Russian Federation

Order № 633 “On the introduction of amendments to the Rules of state registration of medical devices” came into force in June 2018. This normative document introduced the amendments to the range of important processes, including the confirmation of sample import. According to the Order, from now on the registration dossier should contain the hard copy of the sample import

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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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