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Is an annual review required for 2A class medical device registration in Russia with RZN?
Release time：2024-12-03 16:08:57 The author: source:
No, an annual review is not required for Class 2A medical device registration in Russia with Roszdravnadzor (RZN). Once the Registration Certificate is issued, it is typically valid indefinitely unless specific circumstances arise that necessitate a review or update.

No, an annual review is not required for Class 2A medical device registration in Russia with Roszdravnadzor (RZN). Once the Registration Certificate is issued, it is typically valid indefinitely unless specific circumstances arise that necessitate a review or update. However, there are obligations and considerations manufacturers must keep in mind post-registration:

Post-Registration Obligations

1. Notification of Changes

Manufacturers or their authorized representatives must notify RZN in case of:

  • Design Changes: Modifications to the device's design or intended use.
  • Manufacturing Process Changes: Updates to the production process or facility.
  • Labeling or IFU Updates: Changes to the labeling or Instructions for Use (IFU).
  • Ownership Changes: Transfer of the registration holder's rights.

Failure to notify RZN of significant changes can result in penalties or suspension of the registration.

2. Post-Market Surveillance (PMS)

  • Conduct ongoing post-market surveillance to ensure the device continues to meet safety and performance standards.
  • Report any adverse events or safety concerns to RZN as part of vigilance requirements.

3. Periodic Reassessment for Compliance

While the certificate does not require an annual review, RZN or other regulatory bodies may conduct periodic audits or inspections to:

  • Verify compliance with regulatory standards.
  • Confirm that the device operates as intended and is free from safety issues.

4. Renewal or Re-Registration

Although the registration is indefinite, you may need to renew or re-register the device in the following scenarios:

  • Regulatory updates from RZN or the EAEU.
  • Introduction of new technical standards or testing requirements.
  • Re-certification requests due to changes in the device.

Conclusion

No formal annual review is mandated for Class 2A medical devices in Russia. However, manufacturers must maintain vigilance in complying with post-market obligations, notify RZN of significant changes, and prepare for potential audits or reassessments when required.

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