The time required to obtain RZN certification for Class C medical devices can vary based on several factors, including the complexity of the device, the completeness of your application, and the efficiency of the review process. Generally, the process can take several months. Here’s a breakdown of the typical timeline and review steps:

1. Preparation Phase (1-2 Months)

• Documentation Preparation: Gather and prepare all necessary documentation, including the technical file, risk management documents, and quality management system records.
• Consultation and Appointment: If needed, consult with regulatory experts and appoint a local authorized representative in Russia.

2. Application Submission (1-2 Weeks)

• Submit Application: Complete and submit the RZN application form along with all required documentation.

3. Initial Review (2-4 Weeks)

• Review by RZN: RZN will conduct an initial review of your application and documents. They may request additional information or clarification during this stage.
• Clarification and Resubmission: If RZN requests further information or clarification, address these requests promptly and resubmit the required documents.

4. Inspection and Evaluation (1-2 Months)

• Facility Inspection: RZN may perform an inspection of your manufacturing facility to verify compliance with regulatory and quality management requirements.
• Technical Evaluation: RZN will evaluate the technical documentation, clinical data, and risk management reports.

5. Certification Decision (2-4 Weeks)

• Decision-Making: After the review and inspection, RZN will make a certification decision. They will issue the certification if all requirements are met.
• Certification Issuance: Receive the certification and any accompanying documentation.

6. Post-Certification (Ongoing)

• Compliance Monitoring: Continue to monitor device performance, handle post-market surveillance, and report any adverse events to RZN.
• Prepare for Renewal: Plan for certification renewal well before the certification expires.

Review Steps

1. Documentation Check: Ensure all required documents are complete and correctly formatted.
2. Initial Review: RZN reviews the application for completeness and compliance with regulations.
3. Request for Additional Information: If necessary, provide additional information or clarification.
4. Facility Inspection: Undergo an inspection of the manufacturing facility.
5. Technical Evaluation: RZN evaluates the technical and clinical data.
6. Certification Decision: RZN makes a decision and issues the certification if the device meets all requirements.

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