NMPA published ten draft guidelines for IVDs on June 23, 2022, for feedback. They are proposed to direct manufacturers for local type testing and regulatory approval.
- Guideline on Blood Glucose Monitoring System for Self-Testing
- Guideline on Tumor Marker Quantitative Detection Reagents
- Guideline on Influenza Virus Antigen Detection Reagents
- Guideline on Influenza Virus Nucleic Acid Detection Reagents
- Guideline on Pathogen-specific M-type Immunoglobulin Qualitative Detection Reagents
- Guideline on HBV DNA Quantitative Detection Reagents
- Guideline on Drug Abuse Detection Reagents
- Guideline on Gene Mutation Detection Reagents Related to Individualized Cancer Therapy
- Guideline on Toxoplasma, Rubella Virus, Cytomegalovirus, Herpes Simplex Virus Antibody and G-type Immunoglobulin Antibody Affinity Detection Reagents
- Guideline on Instruction for Use of In Vitro Diagnostic Reagents
For English version of any draft guidelines above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
