A class of imported medical devices product validation is necessary
8.10.1 should be based on product quality requirements to determine the product's initial contamination of bacteria and particulate contamination control level and the formation of documents to specify the intermediate product storage environment requirements and storage time.
Check whether the initial contamination of bacteria and particulate contamination of the product control level of the document, whether the document specifies the storage environment and storage time of intermediate products. (Validation of storage environment requirements and storage time of intermediate products)
This validation is also required by the specification
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