Vitebsk enterprise "Simurg" has mastered the production of two import-substituting contraceptives

May 7, Vitebsk / Sergey Kochetov - BELTA /. Closed Joint Stock Company "Medical Enterprise" Simurg "has mastered the production of two new modifications of intrauterine contraceptive devices, which have no analogues in the post-Soviet space. This was reported to a BELTA correspondent by Deputy Director of the enterprise Oleg Akhtanin. The new models "Yunona Bio Multi (with a copper coil) and" Yunona Bio Multi Ag "(with a bimetallic wire" copper-silver ") were developed by the enterprise's specialists and are domestic analogues of the popular foreign contraceptive model Multiload. The developments have been registered with the Ministry of Health of Belarus, and from June 2009, Simurg intends to begin active sales of the products in the country. The new contraceptives, in terms of their characteristics, are not inferior to foreign analogues and will be cheaper than imported products. In parallel, the new models are undergoing registration in Russia, Ukraine, and Kazakhstan, and after obtaining registration certificates, Simurg will begin exporting the products to these countries. In addition, the enterprise has developed and patented an intrauterine contraceptive that uses nitinol wire as an active element - a metal with a shape memory effect. The development was carried out jointly with scientists from the Institute of Technical Acoustics of the National Academy of Sciences of Belarus and has a number of advantages, including ease of use and increased contraceptive effect, noted Oleg Akhtanin. Currently, the enterprise is working on introducing the new device into production. "This process is quite labor-intensive and involves a large number of tests, so it is difficult to predict the start of mass production of the new development," noted Oleg Akhtanin. The product belongs to the third class of potential risk of use according to the European Union classification for medical devices. To allow the model into medical practice, a multi-stage verification system must be completed, including technical and toxicological tests, and biological safety tests. The final stage is clinical trials, upon successful completion of which and obtaining a registration certificate from the Ministry of Health, the product can be launched into serial production and brought to market. The Vitebsk medical enterprise has been developing and producing intrauterine contraceptives under the "Yunona" trademark since 1991. During this time, the production of 9 modifications of these products has been mastered through the full technological cycle - from production to sterilization and packaging. 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. Simurg's quality management system is certified according to the requirements of the international standard ISO 9001:2000. The enterprise has CE certificates for almost the entire range of products, confirming their compliance with the requirements of the EU Directives on safety and quality. About 60% of the products are exported to 12 countries, mainly in the CIS and Europe, and work is underway to enter the markets of Southeast Asian countries. CJC "Medical Enterprise" Simurg "was founded in 1991 and specializes in the production of medical devices for obstetrics and gynecology. Today, the enterprise has mastered the production of more than 30 modifications of products of all three classes of potential risk of use according to the European Union classification for medical devices. The enterprise employs more than 150 people. -0-