Support services for importing medical devices for Russia
Commonwealth of Independent States Certification

Safety & EMC Certification & Registration Process

  • Advisory services for classification and product range grouping to different classes of medical devices
  • Testing services (toxicology, safety tests, EMC and clinical trials) are performed by authorized institutions in Russia and exclusive testing partners
  • Translation services
  • Preparation of complete and sufficient Design Dossier (submittal package - Technical File) for successful registration
  • Coordination services for application submission, testing and receipt of Registration Certificate
  • Certificate and Declaration of Conformity (GOST R) and Custom Union Technical Regulation

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