What Should Be Noticed In The Shelf Life Verification Of Non-active Implantable Devices With Sterilized Packaging?

In addition to the contents mentioned in the “Guidelines for the Registration Application Dossiers of Shelf Life of Non-active Implantable Medical Devices”, the shelf life verification of non­active implantable device products should ensure that the verified packaging materials, packaging methods and sample are consistent or representable with the final products released from the factory. During the design and development of the product, any changes to the above content should lead to re-verification. The shelf life of the product should be determined in consideration of the longest time that the product itself can maintain stable performance and the longest time that the package can maintain stable performance of the sterile barrier and packaging. In the quality system control, the product packaging materials, especially the primary packaging materials, should be controlled for microbial and particulate contamination.