After applying for RZN certification of Class I medical devices, you must adhere to the following regulations and requirements:

1. Compliance with Russian Regulations: Ensure ongoing compliance with Russian Technical Regulations, such as TR TS 020/2011, which governs medical device safety and performance.

2. Post-Market Surveillance: Implement and maintain a post-market surveillance system to monitor the device’s performance, report adverse events, and address any issues that arise.

3. Record Keeping: Maintain accurate and up-to-date records of the device’s manufacturing, testing, and compliance status.

4. Quality Management System: Continually uphold the quality management system standards, like ISO 13485, and perform regular internal audits.

5. Product Updates: Notify Roszdravnadzor of any significant changes to the device, its design, or its manufacturing process that could affect its compliance.

6. Labeling and Documentation: Ensure that all labeling and documentation remain accurate and comply with Russian requirements throughout the device’s lifecycle.

7. Renewal and Compliance Checks: Be aware of the certification’s validity period and prepare for renewal. Stay updated on regulatory changes that may affect your certification.

Adhering to these requirements helps maintain the validity of your RZN certification and ensures continued compliance with Russian regulations.

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