During the COVID-19 pandemic, sectors of the economy such as education and health are particularly digitalized. Of course, it cannot be said that the current situation was a reason for the development of information technologies, but significantly contributed to the involvement of a large number of people in the transition to remote format of work. In this regard, telemedicine technologies
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With the development of technologies and the integration of “physics” and “chemistry” a variety of products , which are no longer drugs in the form of classic dosage forms (tablets, ointments, etc.), but the whole systems of delivery of a medicinal substance come into the pharmaceutical market. Such systems involve the use of auxiliary elements that may prove to be
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Fast track registration – Order of Russian Government 430 (as well as 804) – is prolongated until 2022. Already issued registration certificates should be renewed.
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Electromagnetic compatibility (EMC) is the modern concept that combines such popular electromagnetic phenomena as radio interference, effects on the network, overvoltage, voltage fluctuations in the network, electromagnetic influences, grounding effects, etc. In recent decades, there has been a rapid growth in the development of medical electrical products and systems. EMC for medical devices (MD) can be defined as “the ability
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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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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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Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products: medical devices with 1 risk class are included in this list (for example, gloves), “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate
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Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot or so called factory audit for testing) are not applicable. Introduction Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January 2014 “On Approval
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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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Technical testing and toxicological testing of medical devices should be carried out in a testing laboratory with the appropriate scope of accreditation. Information on the accreditation of the laboratory can be found in the general access on the website of the Federal Service for Accreditation (RusAccreditation). How to check the scope of laboratory accreditation: Visit the RusAccreditation website in the
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