According to a Decree of the Government of the Russian Federation No. 894, dated 31 May, 2023, the Rules are set out for the labelling of certain types of medical devices using identification means. This Decree establishes that the parties involved in the circulation of certain types of medical devices shall submit an application to the State Information System for
Read moreOn 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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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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