One of the articles in the US medical device registration section was devoted to the PMA (premarketing approval) procedure. As part of this procedure, a dossier must be submitted to the FDA, consisting of two parts – administrative and technical. This article will consider the documents included in the dossier. The dossier itself is called “Premarket approval application”. The applicant
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In Russia, there is a risk of disappearance of tests for genetic breakdowns and oncological diseases. According to information from some laboratories, there is a risk of stopping the so-called FISH studies. It can happen because the American manufacturer of equipment, reagents, consumables, and software Thermo Fisher Scientific left the country. Fluorescence in situ hybridization (FISH) is a molecular cytogenetics
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With reference to the current economic situation, in April two resolutions of the Council of the Eurasian Economic Commission were adopted, namely No. 46 dated 5 April 2022 and No. 63 dated 12 April 2022, which changed the import duty rates for a particular group of goods. Pursuant to the above-mentioned resolutions, upon import of goods from the list an
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Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our comparison below: No. Item National system EAEU 1 Main document Decree of the Government of the Russian Federation No. 135 dated 09.02.2022 “On approval of the Rules for arranging and conducting inspections of the production
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Are Wearable Devices Considered Medical Devices? According to the definition of the Federal Service for Surveillance in Healthcare: Medical devices are any instruments, apparatuses, devices, equipment, materials and other items used for medical purposes individually or in conjunction, or together with other accessories necessary for the operation of the aforementioned items as per indications; this includes also specific software products;
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USA In the USA, medical device regulators consider wearable devices to be low-risk devices and therefore do not label them. For example, the U.S. Food and Drug Administration (FDA) considers such products to be “general wellness” products. The FDA believes that wearable devices pose low risks to user safety and therefore refrains from regulating them. Manufacturers either self-regulate the production and
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How to understand that this is a wearable device? In the previous article we analysed in detail the foreign and domestic definitions of the concept of a wearable device. Now we will try to summarize all the criteria to define a wearable device by emphasizing the foreign interpretation. After all, the conceptual model of this area was first developed abroad.
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Introduction So-called wearable technologies are becoming increasingly popular. This concept, however, came to us from the West. Therefore, you can find some inconsistencies in Russia when trying to explain what is meant by a “wearable device”. It seems that a couple of words are missing in such a name for the full picture. In this article we have tried to
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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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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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