[The State Food and Drug Administration issued the "Guiding Principles for Medical Device Good Manufacturing Practice Independent Software Inspection"] On October 30, the State Food and Drug Administration organized the revision of the "Medical Device Good Manufacturing Practice Independent Software On-site Inspection Guiding Principles" (Food and Drug Administration Comprehensive Equipment Administration [2020] No. 57) to form the "Medical Device Good Manufacturing Practice Independent Software Inspection Guiding Principles", which is now issued. The "Guiding Principles for Independent Software Inspection" will be implemented from November 1, 2026, and the "Guiding Principles for Independent Software On-site Inspection of Medical Device Production Quality Management Standards" (Drug Supervision Comprehensive Equipment Management [2020] No. 57) will be abolished at the same time. Starting from November 1, 2026, the drug regulatory department will carry out production license verification and post-market surveillance inspections of independent software medical devices, and determine the results in accordance with the "Guiding Principles for Independent Software Inspection". Checks related to software components are performed according to the instructions.