Tag Archives: Medicaldevices

PMA dossier for the 3rd class medical devices.

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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Premarketing approval for III Class medical devices.

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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Amendment Regulation of the Government of the Russian Federation of September 30, 2015 N 1042

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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Pre-Submission Process for IVDs.

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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IVD regulatory approval process in European Union.

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 medical devices for fast track registration – increased by Government

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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The first list of type codes under Decree No. 552 has been published

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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