Guidelines For Stability Studies Of Non-active Implantable Medical Devices (March 16, 2022 Revision)

The Guidelines are intended to guide the applicants in the preparation of stability study and registration application dossier of non-active implantable medical devices and to provide the reviewers a reference for the technical review.

These guidelines provide the general requirements for the stability study on non-active implantable medical devices. The applicant shall determine whether the contents in these guidelines are applicable according to the specific characteristics of product. If not applicable, specific reason and corresponding scientific evidences should be provided, and contents of registration dossier should be enriched and refined according to specific features of the product.