Vitebsk enterprise "Simurg" will switch to CE marking of all manufactured medical devices in 2010

January 29, Vitebsk / Sergey Kochetov - BELTA /. CJSC "Medical Enterprise Simurg" (Vitebsk) plans to expand the scope of CE marking to all manufactured medical devices in 2010, Deputy Director of the enterprise Oleg Akhtanin told a BELTA correspondent. Currently, about 60% of the enterprise's product types have CE marking, confirming their compliance with the requirements of the European Union directive on safety and quality of medical devices. To expand the scope of such marking, the enterprise is preparing to undergo certification of its quality management system for compliance with the requirements of the ISO 13485 standard in an authorized EU body. "This is a specialized standard for medical devices, the implementation of which will allow us to cover the entire range of manufactured products with marking and increase the export potential of the enterprise in the highly competitive Western European market," said Oleg Akhtanin. In addition, in 2009, Simurg underwent recertification of its quality management system for compliance with the requirements of the ISO 9001:2009 standard. The enterprise exports about 70% of its manufactured products, and according to the results of 2009, the volume of export supplies increased by 35% compared to 2008. Simurg's export geography covers more than 10 countries, including Russia, Kazakhstan, Moldova, Ukraine, as well as Central Asian countries. "These are traditional markets for us, our products have a stable reputation for European quality medical devices, which allows us to constantly increase the volume of supplies, including new types of products," noted Oleg Akhtanin. Medical devices manufactured in Vitebsk are also supplied to Poland, Romania, and Cyprus. In 2010, the enterprise is preparing to enter the markets of Hungary and the Czech Republic, where Simurg's products are undergoing registration with national ministries of health. Simurg considers the markets of the Middle and Far East as promising areas for export expansion. CJSC "Medical Enterprise Simurg" was founded in 1991 and specializes in the production of medical devices for obstetrics, gynecology, and urology, including intrauterine contraceptives, probes, and other instruments. Currently, the enterprise has mastered the production of 45 modifications of products of all three classes of potential risk of use according to the classification of the European Union applicable to medical devices. In its innovation activities, the company actively cooperates with the Vitebsk State Medical University and the Institute of Technical Acoustics of the National Academy of Sciences of Belarus. -0-