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- 2024-08-21Adherence to Regulations: Ensure that the device continues to meet all applicable Russian regulations and standards.
- GOST Standards: The Russian system of technical standards includes GOST R standards that are applicable to medical devices. Relevant GOST standards may cover areas such as safety, performance, and quality control.
- 2024-08-21Detailed Description: Outline the device’s design, function, and intended use.
- Description: Gathering and preparing the necessary documentation, including technical specifications, clinical data, and compliance evidence.
- 2024-08-21Your device must meet Russian regulatory requirements, which may include specific safety, performance, and quality standards.
- Technical Documentation: Device description, technical specifications, user instructions, and other relevant details.
- Device Description: Detailed description, including design, function, and intended use.
- Gather all necessary documentation and ensure compliance with Russian regulations and standards.
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