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Medical registration

I. Overview

• Medical device registration certificate is required for the sale and use of medical devices in Russia

II. Main process

• 1. Preparation of technical documentation
• 2. Notarization of documents
• 3. Evaluation of technical documents
• 4. Organization of delivery of test samples to Moscow
• 5. Evaluation of the document, review, addition
• 6. Submitting an application and getting approval
• 7. Examination and review of documents (stage I)
• 8. Clinical trials (defined by the product)
• 9. Examination of documents (stage II)
• 10. The Russian registration certificate of a medical device was received

III. List of technical documents

• 1. Power of attorney
• 2. Application
• 3. Manufacturer's details (exact company name in Chinese and English, address, contact person and contact information, etc., if the registered address is different from the actual production address, please check separately)
• 4. Appropriate manufacturer's qualifications (valid business license, organization code certificate, tax registration certificate, trademark certificate, patent certificate, export license / certificate of free sale, etc.)
• 5. Medical device CE certificate and EU declaration
• 6. ISO13485 certificate (during the validity period)
• 7. Product information (exact product name in English and Russian, model, spare parts list, customs code, etc.)
• 8. Product brochures
• 9. Product manual (in English or Russian, including the intended use of the product, requirements for use, requirements for disinfection and sterilization, etc.)
• 10. Product drawings (circuit diagram, electrical drawing, packaging drawing)
• 11. Map of product labels (in English or Russian)
• 12. Product test report (functionality, toxicology, clinical report, CE test report, etc.)
• 13. Risk analysis
• 14. Others