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Single uses medical devices: UK guidance on remanufacturing June 2016Contents 1Executive summary ......................................................................................32Introduction
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Single-use medical devices are products that are intended for one-time use on a single patient and are not designed to be reprocessed or reused on another patient.
Manufacturers, importers, and distributors of single-use medical devices are required to file reports with the appropriate regulatory authorities.
Single-use medical devices reports can be filled out electronically through the designated regulatory authority's online portal or submitted via mail.
The purpose of single-use medical devices is to prevent the spread of infections between patients by ensuring that each device used in a medical setting is sterile and free from contamination.
Information that must be reported on single-use medical devices includes product identification, manufacturing details, sterilization methods, and any adverse events that occur during use.
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