NMPA Change Registration Dossier
Source: NMPA Notice 2021-121, Attachment 7 — Change registration requirements.
Full Chinese detail: 变更注册.
Use this path for substantive changes to Class II/III registration certificates (name, PTR, models, composition, intended use, imported manufacturing site, etc.). Administrative-only changes use Change filing.
Structure (change-focused)
- Regulatory information — application, associated docs (prior certificate + past changes), pre-submission records, declarations
- Summary — change rationale + comparison tables
- Non-clinical — change-related risk management, PTR/test reports for changed parts, research
- Clinical — only if the change may affect safety/effectiveness
- IFU — before/after comparison
- QMS — adjustments for the change; inspection when design/materials/process/use changes
Do not reuse the full initial 6-chapter checklist without trimming to the change scope.