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- Prepare Documentation: Gather all necessary documents, including the application form, technical documentation, quality management system details, and proof of compliance.
- Application Form: Completed and signed, available from Roszdravnadzor.
- Prepare Documentation: Gather all necessary documents, including product specifications, technical descriptions, and quality management system information.
- Register with Roszdravnadzor: Begin by contacting Roszdravnadzor, the Russian Federal Service for Surveillance in Healthcare. You can visit their official website or local office to obtain the necessary forms and detailed instructions.
- Costs: Generally, fees include application processing, testing, and potential inspection costs. These can range from a few thousand to several thousand USD, depending on the complexity of the device and additional services required.
- Technical Documentation: Include detailed product specifications, technical descriptions, and labeling information.
- Prepare Documentation: Compile necessary documents including product specifications, technical descriptions, quality management system details, and conformity with Russian standards.
- Document Preparation: Prepare technical documentation, product specifications, quality management system details, and evidence of compliance with applicable standards.
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