Import, sale and use of Medical Devices and Equipment
without a GOST-R Quality Certificate are legally
forbidden in Russian Federation. In order to obtain a
GOST-R Quality Certificate for Medical Devices and
Equipment, a License of Use should be obtained from the
Ministry of Health of Russian Federation.
Procedures are as follows for this purpose :
An official application is filed for the relevant
Medical Device or Equipment.
A charge determined on the device value declared in the
application, is deposited to the Ministry of Health.
2 product samples are sent to Moscow.
One of the samples is examined on technical basis and a
“Technical Expertise Report” is issued.
The other sample is examined on medical basis and a
“Medical Expertise Report” is issued.
These two reports are combined and presented to a
commission of 5 members who gather once in 2 months. A
License of Use by Ministry of Health is issued for the
device or equipment in question for a period of 10 years
if it is found compliant.
Based on this License, a GOST-R Quality Certificate is
issued according to the normal procedures (for a period
of 3 years in general). In some cases, the GOST-R
Quality Certificate is issued by the organization that
issues the expertise report and takes part in the
commission as a member. This is an important factor that
makes the process easier.