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.
