NMPA published the twelve guidelines (IVD Guidelines) for in vitro diagnostic reagents-related products on January 3, 2024. It comes as File No.1 released by NMPA CMDE (Center for Medical Device Evaluation) in 2024.
Complete List
- Guideline on raw materials of in vitro diagnostic reagents
- Guideline on Brucella IgM/IgG Antibody Detection Reagents
- Guideline on Hepatitis C virus antibody detection reagent
- Guideline on Zika virus nucleic acid detection reagent
- Guideline on Aspergillus nucleic acid detection reagent
- Guideline on blood glucose monitoring system for self-testing
- Guideline on writing instructions for in vitro diagnostic reagents
- Guideline on tumor marker quantitative detection reagents
- Guideline on Influenza virus nucleic acid detection reagent
- Guideline on Influenza virus antigen detection reagent
- Guideline on pathogen-specific M-type immunoglobulin qualitative detection reagent
- Guideline on Hepatitis B virus DNA detection reagent
For our comprehensive review of “Guideline on raw materials of in vitro diagnostic reagents”, please visit HERE
IVD Guidelines
For our recorded webinar of “Understanding IVD Reagents Registration Requirements: China & US Perspectives”, please visit HERE
For IVD classification draft catalog, click HERE
For the Guideline for IVD Overseas Clinical Data Acceptance, click HERE
