Medical Certification & Registration Process

Our Services

Medical

• Advising 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 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