• English
  • Русский
8 (800) 505-34-91
(звонок из регионов бесплатный)
TUV SUD in EEU countries
150 years of inspiring trust
 

Registration of Medical Devices

We offer services on the execution and issuance of registration certificates for medical products, as well as medical equipment. The certificate confirms the fact of registration of medical equipment. Medical devices cannot be used for healthcare purposes without the registration in the Ministry of Healthcare and Social Development of Russian Federation.

 

The Russian legislation on medical devices:

   

2006/10/30

"On the approval of Administrative Regulations of the Federal Service for Supervision of Health and Social Development for the fulfillment of state functions for the registration of medical devices“, came into force 2006/12/29

2008/12/16

“On the methodical recommendations for preparing documents for registration of medical products" N 01И-809/08 (Roszdravnadzor)

2009/12/01

Resolution “On replacement certification by declaration of conformity for majority of medical devices”№ 982, came into force 2010/02/15

2011/11/21

Federal Law №323-FL “On healthcare of citizens in the RF”

2012/06/15

Resolution №7-N of the Russian Ministry of Health “On import of medical equipment on the territory of the RF for registration purpose”

 

Documents required for registration of medical equipment:

  • Specifications for goods with technical parameters
  • Protocols of works’ test reports (if available)
  • Application instruction
  • Sample
  • A picture of the medical device / equipment

GOST R Inquiry form (Request for quotation) [ DOC 2260 kB ]

On-line Inquiry form (Request for quotation)

NEW SERVICES:

Certification of Conformity to Standards of RUSSIA, KAZAKHSTAN, BELARUS (Customs Union)