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
Read more
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
Read more
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
Read more
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
Read more
National registration system for medical devices in Russia (general registration by Order 1416 from 27/12/2012) is prolongated until the end of 2022 as well as national systems of other Members
Read more
Point-of-care testing devices Point-of-car (POC) diagnostics becomes increasingly popular in nowadays medicine. In Russia, there is no exactly corresponding technical article, however one can’t say that there are no similar devices available on the local market. Let’s have a look on those devices and try to understand how their manufacturing and sales are regulated. Definition Abroad The term concerned consists
Read more
The common space of the European Union allows the member states to take a more comprehensive and global approach to solving many issues, including the problem of circulation of falsified medical devices. As a result of the implementation of the global approach, regulations are being created to strengthen international cooperation, including with countries outside the EU (for example, the Convention
Read more
The circulation of counterfeit medical devices (MD) and other medical products* is a global problem that poses a risk to public health and can cause significant economic damage. In this regard, there was a need to develop a single document aimed at combating counterfeit medical products. This was the MEDICRIME Convention. The MEDICRIME Convention (Council of Europe Convention on the
Read more
The system of national marketing authorization of medical devices in the Russian Federation uses the Nomenclature Classification of Medical Devices by Type (hereinafter referred to as “NCMD”). In the system of marketing authorization of Medical Devices in the EAEU, there is a very close equivalent in content: the European Medical Device Nomenclature (hereinafter referred to as “EMDN”). According to EAEU regulatory
Read more
For the first time, the Federal Service for Surveillance in HealthCare is conducting remote inspection of medical device manufacturing located abroad. The FGBU VNIIIMT of Roszdravnadzor with the participation of Roszdravnadzor specialists began for the first time the remote inspection of medical device manufacturing located abroad (the manufacturing site, Tianjin Huahong Technology Co., Ltd, is located in the People’s Republic
Read more
You must be logged in to post a comment.