WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

“…In adopting a policy on the reprocessing of SUMDs, the regulatory authority should consider the following: reprocessing of a SUMD as labelled by its manufacturer is not permitted unless the reprocessed SUMD meets the same initial standards as those of the original manufacturer. To allow their reuse, the entity that reprocesses and distributes medical devices labelled by their original manufacturer for single-use only will be subject to the same requirements of safety, quality and performance as manufacturers of new devices (64–67).”