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Is annual review required for RZN certification of Class I medical devices?
Release time：2024-08-20 11:17:21 The author: source:
Ongoing Compliance: Ensure continuous adherence to safety, performance, and quality standards as required by Roszdravnadzor.

For Class I medical devices, an annual review is not typically required for RZN certification. However, you must maintain compliance with Russian regulations and standards throughout the device's lifecycle. Key points include:

  1. Ongoing Compliance: Ensure continuous adherence to safety, performance, and quality standards as required by Roszdravnadzor.

  2. Post-Market Surveillance: Implement post-market monitoring and report any issues or adverse events.

  3. Document Updates: Keep technical documentation and labeling up-to-date with any changes in regulations or device modifications.

  4. Certification Renewal: Be aware of the certification's validity period and prepare for renewal if necessary.

Regularly reviewing and updating your compliance practices helps ensure that your device remains in good standing with Roszdravnadzor requirements.

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