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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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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The purpose of the medical device classification according to the requirements of US law is to obtain a seven-digit code, which in the future will determine the registration procedure. In general, the code for each medical device in the United States is as follows: 21 CFR XXX.XXXX, where 21 CFR is the Title 21 of the Code of Federal Regulations
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As already mentioned in the general article on MD regulation, in the United States there is a unified regulatory system for MD, meaning that there is no division into MD and MD for in vitro diagnostics. The same rule is applied to the MD classification. In the USA MD classification is based on two criteria: Intended use including indications for
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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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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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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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