The Federal Agency for Technical Regulation and Metrology (Rosstandart) passed five new national GOST standards for devices for in-vitro medical diagnostics. The certification is made on a voluntary basis. All these documents are to enter into force on November 1, 2016.
The new GOST standards for in-vitro diagnostic devices are unified rules on the marking of these devices and reagents as well as rules for the preparation of the technical documentation.
The GOST standards have been developed by the "Head Center for Hygiene and Epidemiology" of the Federal Medical and Biological Agency at the Sechenov Research Institute for Public Health.