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Ten IVD Guidelines Issued in One Day

Date:

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.

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