Category Archives: MD regulation

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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Registration of medical devices in Tajikistan.

Currently, the pharmaceutical sector is one of the priorities for development in Tajikistan. In 2020, the government of Tajikistan issued a resolution “On the State Program for the Development of the Pharmaceutical Industry in the Republic of Tajikistan for 2021-2025”.  One of the objectives of the Program is to improve the legal framework of the Republic of Tajikistan in the

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State registration of medical devices in the Republic of Belarus.

As you know, in the near future, namely from January 1, 2022, the five countries of the Eurasian Economic Union will be united by one harmonized procedure for registration of medical devices. However, most countries of the Union have their own national registration procedures. How is the state registration of MD organized in these countries? What are its features for

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