RZN certification in Russia is a mandatory process for ensuring that medical devices, including Class I devices, comply with Russian safety and efficacy standards.

To apply:

1. Document Preparation: Prepare technical documentation, product specifications, quality management system details, and evidence of compliance with applicable standards.
2. Submit Application: File your application with Roszdravnadzor, the Russian regulatory authority, providing all required documents.

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4. Review Process: Roszdravnadzor will review the application and may request additional information or conduct an inspection.

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6. Certification Issuance: If approved, you'll receive a certification confirming that your device meets Russian regulations.

Need more specifics on any part of the process?