NMPA Class I Filing Dossier

Source: NMPA Notice 2022-62.
Chinese: 第一类备案.

Class I uses a filing path, not the Class II/III 6-chapter registration dossier.

Core package

Filing form · associated documents · product technical requirements · full-performance test report + photos · IFU/labels · manufacturing overview · conformity declaration

Change filing adds a change description/comparison table and updated associated docs as needed.