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 the previous articles under the heading of regulation of the medical device market, we looked at how the registration procedure in the United States looks like in general, and also paid attention to the classification of medical devices and the pre-market notification procedure. This article will focus on devices of the third risk class, in particular, the premarket approval
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On December 22, 2022, Regulation of the Government of the Russian Federation No. 2374 dated December 22, 2022 “On amendments to the list of medical devices, the sale of which in the Russian Federation and import into the Russian Federation and other territories under its jurisdiction, are not subject to taxation (exempted from taxation) with value added tax”, which will
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In the previous part of the article, we considered the purpose of premarket notification procedure, as well as what is meant by a substantially equivalent. In this part of the article, we will try to figure out what this notification consists of. It is worth noting that the composition of the “registration dossier” for a premarket notification is described in
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Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) premarket notification to FDA. What is it and why is it required? A 510(k) is a premarket submission made to FDA to demonstrate that the device
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A Pre-Submission includes a formal written request from a submitter for feedback from the FDA which is provided in the form of a formal written response or, if the submitter chooses, a meeting or teleconference in which the feedback is documented in meeting minutes. A Pre-Submission meeting is a meeting or teleconference in which the FDA provides its substantive feedback
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In the United States, the Food and Drug Administration (FDA) regulates medical devices (including in vitro diagnostic devices). In this article, we will consider how MD is determined in the USA (including the ones for in vitro diagnostics) and how MD can enter the US market. Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is: An
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Approaches to the regulation of in vitro diagnostic (IVD) medical devices vary by country. For example, in the United States, there is no separate classification for IVD devices, and a general regulatory system developed for medical devices is applied. If we talk about the European Union (EU), then the approach is different. For IVD products, a separate classification and a
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List of type codes dated June 28, 2022 based on the results of a meeting of the interdepartmental commission on the formation of a list of types of medical devices subject to circulation in accordance with the Peculiarities of circulation, including state registration features of medical devices in the event of their defectiveness or the risk of defectiveness in connection
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On the website of the Federal Service Rosddravnadzor, the first list of type codes to the Decree of the Government of the Russian Federation No. 552 dated 01.04.2022 has been published (On approval of the specifics of circulation, including the specifics of the state registration of medical devices in the event of their defectiveness or the risk of defectiveness in connection
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