The requirements for the standardization of medical devices for in vitro diagnostics in the Russian Federation are established by the National Standard of the Russian Federation — GOST R 51088-2013. Medical devices for in vitro diagnostics. Reagents, reagent kits, test systems, control materials, nutrient media. Requirements for products and supporting documentation" (approved and put into effect by the Order of Rosstandart dated 08.11.2013 N 1483-st).
The technical and operational documentation of NPO RENAM for its products has been developed taking into account this GOST, as well as other state standards of the Russian Federation in the field of circulation of medical devices.
The presence of a valid ISO certificate of compliance, which is mandatory for the circulation of medical devices in the EAEU (Eurasian Economic Union) market, confirms that our quality management system in relation to the development, production and sale of our products meets the requirements of GOST R ISO 9001-20151 (ISO 9001-2015) and GOST ISO 13485-2017 (ISO 13485-2016).
Organizations that establish requirements for the standardization of laboratory tests: CE (Directive of the European Parliament of the Council of Europe), ROSSTANDART (Federal Agency for Technical Regulation and Metrology).
The presence of registration certificates issued by Roszdravnadzor confirms the compliance of our products with state regulatory requirements for the quality and safety of medical devices put into circulation on the territory of the Russian Federation. There is a valid certificate of origin ST-1 and a declaration of the country of origin of the goods.
We also received a letter from the Chamber of Commerce and Industry, which indicates that there is no need for us to obtain an Examination Certificate for the purposes of procurement for state and municipal needs.
Our kits and individual reagents used in veterinary medicine are not subject to state registration with the Rosselkhoznadzor, as they are not medicinal products for veterinary use. A letter from VNIIS:
• General
• Renamplastin and Reachrome ATIII
