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- Regulations: Familiarize yourself with the Technical Regulations of the Customs Union (TR CU 020/2011) and other applicable standards for Class C medical devices.
- Regulatory Framework: Familiarize yourself with the Technical Regulations of the Customs Union (TR CU 020/2011), which outline the safety and performance requirements for medical devices in Russia.
- Documentation Preparation: Gather and prepare all necessary documentation, including the technical file, risk management documents, and quality management system records.
- 2024-08-23Understand Requirements: Familiarize yourself with the Technical Regulations of the Customs Union (TR CU 020/2011), which outlines the safety and performance standards for medical devices in Russia.
- TR CU 020/2011: This Technical Regulation of the Customs Union outlines safety and performance requirements for medical devices. Ensure compliance with any amendments or updates to this regulation.
- Ongoing Monitoring: Continuously monitor the performance and safety of the device in the market. Collect and review data on adverse events and device performance.
- 2024-08-23Familiarize Yourself with Regulations: Review Russian regulations and the Technical Regulations of the Customs Union (TR CU 020/2011) related to medical devices. Understand the specific requirements for Class C devices.
- Monitoring and Reporting: Continuously monitor the performance and safety of the device once it’s on the market. Be prepared to report any adverse events or issues to RZN promptly.
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