No, annual renewal is not required for the registration of Class I medical devices with Roszdravnadzor (RZN) in Russia.

For Class I medical devices, once the registration is approved and the registration certificate is issued, it is typically perpetual, meaning it remains valid as long as there are no significant changes to the product or its specifications. There is no need for yearly renewals, unlike higher-risk devices (Class II, Class III), which may require periodic renewal and re-certification.

Important Considerations for Class I Registration:

1. Changes to the Device: If there are changes in the device’s design, intended use, or manufacturer, you may need to submit an update or new application to RZN. Significant modifications could lead to the re-evaluation of the device, potentially affecting the validity of the existing registration.

2. Post-Market Surveillance: While there is no annual renewal requirement, manufacturers are still obligated to monitor the performance and safety of their devices on the market. They must report any adverse events or issues related to the device to RZN, as part of the post-market surveillance requirements.

3. Compliance with New Regulations: If there are updates to Russian regulations or standards (e.g., technical regulations or industry guidelines), you may need to ensure that your device complies with the new rules. While this doesn't require a full renewal, you should stay informed about changes that might impact your product's registration status.

Summary:

Once a Class I medical device is registered with Roszdravnadzor, it does not require annual renewal. However, manufacturers must ensure that their device remains compliant with regulatory standards and report any significant changes to RZN if needed.

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