In order to further strengthen the management of the stability research of passive implantable medical devices, the Device Audit Center of the State Food and Drug Administration organized and formulated the Guiding Principles for the Stability Research of Passive Implantable Medical Devices (Revised in 2022), which is hereby issued.

It is hereby notified.

Annex: Guidelines for stability study of passive implantable medical devices (revised in 2022) 

State Drug Administration

Medical Device Technical Evaluation Center

March 15, 2022

Source: National Drug Administration Medical Device Technical Evaluation Center