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- Document Compilation: The time required to prepare and translate technical documentation, quality management system details, and other required materials can vary based on the complexity of the device and the completeness of the submission.
- RZN certification for Class 2b medical devices in Russia signifies that a device has met the regulatory requirements set by Roszdravnadzor (the Federal Service for Surveillance in Healthcare) and is authorized for use within the Russian market.
- Technical Regulation TR 020/2011: Understand the requirements outlined in the Technical Regulation on Medical Devices.
- Technical Regulation: Familiarize yourself with the Technical Regulation on Medical Devices (TR 020/2011) and other relevant Russian standards.
- Document Preparation: Preparing technical documentation, ensuring compliance with quality management standards, and translating documents into Russian.
- Research Regulations: Familiarize yourself with the Technical Regulation on Medical Devices (TR 020/2011) and any relevant Russian standards.
- Technical Regulation on Medical Devices (TR 020/2011): Continual compliance with this regulation is required. Ensure that any updates align with the technical and safety requirements outlined in TR 020/2011.
- Adherence to TR 020/2011: Ensure ongoing compliance with the Technical Regulation on Medical Devices (TR 020/2011), which outlines the safety and performance requirements for medical devices in Russia.
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