Register for Upcoming Webinar on DEC. 8 @ 11AM

2024 China NMPA Bluebook is here:

Seven IVD Guidelines Ask for Feedback


The NMPA issued seven IVDs draft guidelines on December 2, 2022, soliciting public opinions. Feedbacks need to be submitted by December 16, 2022.

  • 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

NMPA also lists the corresponding emails and contact numbers for each of the IVDs draft guidelines. For an English copy of any guideline with its correspondents, please contact us by email We charge nominal fees for the translation.

About China Med Device

China Med Device provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.

Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, IVDs draft guidelines, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

Have Questions?

Related Services


Recent Events

Related Posts


Get Updated

Receive Updates in Your Inbox