GOST R Declaration of Conformity for Medical Devices
RUSTANDARD - Product Registration and Certification
GOST R, Gost Russia, Gost Standard, RTN, GGTN

GOST R Declaration of Conformity for Medical Devices

23 March 2011

From 25/01/2011 to all medical devices, with the exception of eyeglasses, and rubber of condoms, instead of the certificate of conformity GOST R is issued a declaration of conformity GOST R (only update the list of products subject to certification mandatory GOST R, resolution of the gov. No 906 of 13.11.2010). This means that the foreign manufacturer without a permanent establishment in Russia, for now, then they can not obtain a certificate of conformity for serial production. Each importer must obtain the Russian declaration of conformity GOST R for import and to enter into free circulation medical devices in Russia.

We remind, that in addition to these documents, for medical devices is also required registration certificate for the Russian Ministry of Health. It is however not yet clear which of the two documents must be obtained first. Some argue that certification bodies to import medical devices is sufficient declaration of conformity and the Ministry of Health registration can be done later. Others say the opposite. In any case, the possession of the registration certificate of the Minister of Health of Russian pressed to benefit from tax: exemption and / or reduction of customs duties and VAT.