When classifying devices as medical in the Russian Federation, the Federal Service for Overseeing Healthcare (hereinafter Roszdravnadzor) is guided primarily by the definition of medical devices as specified in Clause 1 of Article 38 of Federal Law No. 323-FZ dated 21 November 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter Federal Law No. 323-FZ) and in Clause 2 of Decree No. 1416Read more
Category Archives: MD regulation
Fast track regulation (so called, COVID-19 fast track registration) is prolongated (list of products under regulation). Order of Russian Government 430 from 3rd of April 2020 in action until 2025 (amendments are done). Link to Government source: http://government.ru/news/44084/#Read more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 1113n).
In the previous article devoted to the update regarding safety monitoring, we considered Order 980n “On Approval of the Procedure for Safety Monitoring of Medical Devices” . In this small review, we would like to refer to Order 1113n, which will replace the Order 12n on January 1, 2021 and will be valid until January 1, 2027. Before talking aboutRead more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 980n).
With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety monitoring of medical devices. From January 1, 2021, two legislative acts (Order No. 980n from 15th Sept 2020 (monitoring system) and Order No. 1113n) come into force, which significantly details the procedure for interaction betweenRead more
During the COVID-19 pandemic, sectors of the economy such as education and health are particularly digitalized. Of course, it cannot be said that the current situation was a reason for the development of information technologies, but significantly contributed to the involvement of a large number of people in the transition to remote format of work. In this regard, telemedicine technologiesRead more
With the development of technologies and the integration of “physics” and “chemistry” a variety of products , which are no longer drugs in the form of classic dosage forms (tablets, ointments, etc.), but the whole systems of delivery of a medicinal substance come into the pharmaceutical market. Such systems involve the use of auxiliary elements that may prove to beRead more
Fast track registration – Order of Russian Government 430 (as well as 804) – is prolongated until 2022. Already issued registration certificates should be renewed.Read more
Electromagnetic compatibility (EMC) is the modern concept that combines such popular electromagnetic phenomena as radio interference, effects on the network, overvoltage, voltage fluctuations in the network, electromagnetic influences, grounding effects, etc. In recent decades, there has been a rapid growth in the development of medical electrical products and systems. EMC for medical devices (MD) can be defined as “the abilityRead more
We face both “complex” and “simple” products in the course of work. Let’s clarify what we mean by these concepts. A “complex” product is: – a product incorporating many elements, each of which requires a detailed description in the technical and operational documentation; – highly engineered product; – a product in compliance with international safety standards, possibly even widely distributedRead more
Features of increasing the shelf life of a medical device in case of making amendments to the registration documents
Introduction The shelf life of a medical device determines the period during which the product retains its functional properties and technical specifications established by the manufacturer. After the state registration of a medical device in the territory of the Russian Federation, the established value of the shelf life can be changed in accordance with the Decree of the Government ofRead more