What are the specific requirements for the management of sterile medical devices

The management of single-use sterile medical devices is mainly reflected in the supervision of the production process, the reference documents are as follows:

Supervision and Management of Single-Use Sterile Medical Devices (Interim)

"On the issuance of the quality management standard for the production of medical devices and sterile medical devices implementation rules and standards for the inspection and evaluation of the notice (for trial implementation)"

State Food and Drug Administration Mech. [2009] No. 835