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- Choose a Certification Body: Select an accredited Certification Body (CB) authorized by Roszdravnadzor (Federal Service for Surveillance in Healthcare). The CB will handle the certification process.
- Typically range from $2,000 to $5,000 USD. This includes the administrative costs of processing the application.
- 2024-08-21Technical Documentation:Detailed device description and specifications.
- Device Information: Technical description, intended use, and design details.
- Prepare Documentation: Collect necessary documents such as technical specifications, clinical data, and manufacturing details.
- Prepare Documentation: Gather required documents, including technical documentation, device description, and evidence of compliance with standards.
- Preparation Time: Gathering and preparing all necessary documentation.
- Ongoing Compliance: Ensure continuous adherence to safety, performance, and quality standards as required by Roszdravnadzor.
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