Current State and Development Trends of Domestic Medical Device Market for in Vitro Diagnostics in the Segment of Diagnostic Reagents and Their Kits

Abstract

The problem of import substitution in the Russian medical device market for in vitro diagnostics (MDivd) has not been solved, despite a number of measures taken by the government of the Russian Federation since 2011. The reasons hampering this process are the lack of modern analytical equipment of domestic production and deficiencies of the current regulatory system for MDivd circulation in the market. It is proposed the transition from licensing system of MDivd registration to notification system as a radical measure to solve the problem of import substitution.

A Detection-Service-Mobile Three-Terminal Software Platform for Point-of-Care Infectious Disease Detection System

“…Instruments based on POCT [ 16 , 17 , 18 , 19 ] overcome the limitations of dedicated laboratories, and can meet the needs for timely and local testing in hospital emergencies, epidemic sites, port quarantine, and other scenarios in regards to grassroots health institutions. With the development of POCT, the number of in vitro diagnostic instruments and testing data has also increased [ 20 , 21 , 22 ]. However, the data management mode of traditional in vitro diagnostic instruments has not entirely separated from the manual state, affecting the staff’s work efficiency.…”