01
/ Question/
How to conduct research on the shelf life evaluation of in vitro diagnostic instruments? Can the evaluation of the shelf life of only the core components replace the evaluation of the product’s shelf life?
02
/ Answer/
According to the requirements of the “Technical Review Guidelines for Shelf Life Registration of Active Medical Devices,” the shelf life evaluation research of in vitro diagnostic instruments should be conducted. The shelf life evaluation should be a complete device evaluation, and all components of the product must be included in the evaluation. If certain components do not affect the shelf life of the complete device, reasons should be provided along with supporting documentation. The evaluation of the shelf life of core components cannot replace the complete device evaluation but can serve as supporting evidence for the complete evaluation.
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