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Other Documents and Permissions

 
 Exemption Letter

 License of Use for Medical Devices and Equipment, Ministry of Health

 License of Registration and Use for Measurement Devices


Exemption Letter


Exemption Letter is a document obtained for the products exported to Russian Federation for which a GOST-R Quality Certificate is inapplicable. VNIIS Institute in Moscow is authorized to issue this document.

Exemption Letter is an official letter written to the firm in question and directly to the Russian Federation Customs.


License of Use for Medical Devices and Equipment, Ministry of Health

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.
 

License of Registration and Use for Measurement Devices

Some Measurement Devices are subject to the control and registration by “Federal Institute of Technical Regulations and Metrology” depending on the purpose and types thereof.

The primary products that are subject to this process are as follows :

 Measurement and Weighing Devices used by local markets
 Industrial measurement devices
 Measurement devices related with geodetic and hydrology activities
 Measurement devices related with environmental health
 Measurement devices related with labor and labor health
 Measurement devices related with state-owned enterprises and national security
 Measurement devices related with sports


An application should be filed at "Federal Institute of Technical Regulations and Metrology" with a sample device and GOST-R Quality Certificate in order to obtain License of Use and Registration.

 
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