Filing for class I IVD reagents

• Filing form for Class I MDs

• Safety risk analysis report

• Product technical requirements

• Test report

• Clinical evaluation data

• IFU and label design for minimum marketing unit.

• Information about production

• Certificates

• Statement of compliance

The list is based on:

CFDA circular about issues related to the filing of class I MDs (No. 26)

Registration of class II and III IVD reagents

To be determined.

Basis:

CFDA circular about registration approving work standard of domestic class III MDs and imported MDs