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APPENDIX D Checklist for Medical Devices Is the BUT considered Life Supporting or Online Supporting Equipment? Please provide a document that defines the essential performance of the BUT. Essential
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Medical devices in a refer to instruments, machines, implants, or any other similar article that is used for medical purposes, such as diagnosis, prevention, monitoring, and treatment of diseases or conditions.
Manufacturers and importers of medical devices are typically required to file medical devices in a with the relevant regulatory authorities.
To fill out medical devices in a, one must provide specific information about the device, including its intended use, technical specifications, and compliance with safety standards, and submit the required documentation to the regulatory authority.
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Information that must be reported includes device identification, intended use, labeling, manufacturing details, safety data, clinical data, and risk management information.
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