The NMPA recently issued seven IVDs draft guidelines on December 2, 2022. In China, IVD assay is one certificate. The assay's testing platform requires another certificate independent of whether the system platform is a closed or open.
- Draft Guideline on Submission Materials of Blood Glucose Monitoring System for Self-testing
- Draft Guideline on Registration of Detection of Gene Mutations Associated with Tumor Individualized Therapy
- Draft Guideline on Registration of Hepatitis B virus Deoxyribonucleic Acid Quantitative Detection Reagent
- Draft Guideline on Registration of Influenza Virus Antigen Detection Reagent
- Draft Guideline on Registration of Nucleic Acid Detection Reagent for Influenza Virus
- Draft Guideline on Registration of Antibodies to Toxoplasma Gondii, Rubella Virus, Cytomegalovirus, Herpes Simplex Virus, and G Type Immunoglobulin Antibody Detection Reagent
- Draft Guideline on Registration of Pathogen specific M-type immunoglobulin qualitative detection reagent
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------