When A Non-active Medical Device Changes, Under What Circumstances Should Re-evaluation Of Its Safety Be Considered?

When a non-active medical device changes, re-evaluation of its safety should be considered under circumstances:

Changes in the raw materials or technical indicators used for the product;

Changes in the product’s formula, production process, primary packaging or sterilization process;

Changes in the final product during the shelf life of the product, such as changes in storage or transportation conditions;

Changes in the intended use of the product;

Evidence present showing that the product can cause adverse events when used in humans.