The registration period for a Class 2A medical device in Russia with Roszdravnadzor (RZN) can vary depending on the complexity of the device, the completeness of the application, and whether additional testing or local clinical trials are required. On average, the process takes 6 to 12 months.

Factors That May Extend the Timeline

1. Incomplete Documentation: Missing or incorrect documents can lead to delays as RZN requests additional information.
2. Local Clinical Trials: If the clinical data does not meet Russian requirements, additional trials can significantly extend the timeline.
3. Complex Devices: Devices with more complex designs or higher risk levels may require more extensive testing.
4. RZN Backlog: Delays can occur due to high volumes of applications being processed.

Validity of the Registration Certificate

Once issued, the Registration Certificate for a Class 2A medical device is generally valid indefinitely in Russia unless:

• The device is modified significantly.
• Regulatory standards change.
• The registration is revoked due to non-compliance or safety concerns.

By proactively addressing all regulatory requirements and ensuring a complete submission, manufacturers can minimize delays and expedite the registration process.

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