5 docs tagged with "guidance"

NMPA guidance on clinical evaluation — equivalent device, literature evidence, and clinical data requirements.

NMPA inspection preparation guidance and GMP audit checklists for medical device manufacturers.

NMPA and CMDE technical guidance indexed by topic for medical device registration in China.

CMDE registration dossier checklists, review guidelines, and common deficiency guidance.

NMPA standalone software and AI/ML algorithm change protocol guidance documents.