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2024 China NMPA Bluebook is here:

NMPA: Six IVD Guidelines Published in One Day


NMPA In Vitro Diagnostic Reagents

NMPA In Vitro Diagnostic Reagents

The NMPA In vitro diagnostic reagents issued 6 guidelines on September 28, 2022:

  • Guideline on Qualitative Detection In Vitro Diagnostic Reagent Analysis Performance Evaluation
  • Guideline on In Vitro Diagnostic Reagent Reference Range Determination
  • Guideline on Quality Control Product – Quality Control Product Assignment
  • Guideline on Hepatitis E Virus IgM/IgG Antibody Detection Reagents
  • Guideline on Human Immunodeficiency Virus Antigen and Antibody Detection Reagents Preclinical Trial
  • Guideline on EBV Antibody Detection Reagents

For an English copy of any NMPA In Vitro Diagnostic Reagents guideline above, please contact us or email We charge nominal fees for the translation.

About China Med Device, LLC

China Med Device, LLC ( 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, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

Which Services We Can Support You With

CMD has offices in both Boston and Beijing to give our clients quick access to a local, bilingual and bicultural team. Count on CMD as your partner throughout the complete product life cycle. Here are our key services and areas of expertise:


Registration, renewal and modification
Local type testing coordination
Quality Management System (QMS)
Post-market surveillance/Local Agent representation

Clinical Research Organization (CRO)

Clinical trial management / CER
Overseas clinical data acceptance
Real-World Data / Evidence (RWD/E)

Business & Commercialization

China market assessment and due diligence
Reimbursement analysis

Device Types

Class I – III, active/passive, implants software/SaMD, combination products
IVD/Diagnostics: reagents, CDx, systems, test kits, assays
Clinical indications: orthopedics, ophthalmology, cardiovascular, IVF, oncology, radiology, imaging

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