Class III medical device fast expiration management requirements

Advance planning, device evaluation.

1, advance planning: assessment and planning begins at least six months before the expiration date of medical devices to ensure that there is sufficient time to deal with the replacement or continuation procedures.

2, equipment assessment: the upcoming expiration of the medical device performance, safety and suitability assessment, to determine the need to update or continue to use. Consider the device's frequency of use, maintenance records, failure rate and impact on clinical services.