Regulatory Affairs in Russia

• Product registration – full process (product documentation for registration submission to Federal Service for 

  Surveillance in Health Care and Social Development (Roszdravndazor), translation of registration dossier,
  identification of registration agents, distributor, establishing product standard, application for sample-product    
 import permission for registration test, coordination of obtaining GOST R Certificate in Federal Agency for Technical  
 Regulation and Metrology (former Gosstandard), coordination of all related activities)

• Translation of technical documents into Russian
• Courses on Russian regulations of medical devices and IVD devices
• Coordination between you and your partner in Russia