Category Archives: MD regulation

The procedure for the import of medical devices for the purposes of registration in 2023.

On May 2, 2023, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for the purposes of state registration. According to Order No. 201n, the applicant must notify Roszdravnadzor of the intention to import medical devices in the electronic form for the purposes of state registration. The notification procedure for the import of unregistered

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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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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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