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2025 China NMPA Bluebook is here:
Quantitative tumor marker testing reagents encompass a wide variety of products with numerous applications. The revised Guideline on Quantitative Tumor Marker Testing Reagents, released on January 3, 2024, serves as
The NMPA Medical Device Standardization Administration issued the “Third Batch of Medical Device Classification Results for 2024” on November 20, 2024. The document identifies 268 IVD reagents. It is the
The NMPA Center for Medical Device Evaluation (CMDE) published an article on pediatric In vitro diagnostic (IVD) on October 21, 2024. According to the definition in Clinical Pediatrics, the scope
PD-L1, a transmembrane protein, binds to PD-1 to transmit inhibitory signals, helping tumor cells evade T-cell attack. Blocking the PD-1/PD-L1 pathway is effective in cancer treatment. PD-L1 expression levels predict
The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013 with two supplemental updates in 2017 and 2020 respectively. NMPA issued the “Draft Classification
NMPA published the four IVD-related guidelines on January 18, 2024. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process. Significance of Guidelines The guidelines
NMPA published the “Guideline on Core Raw Materials of In Vitro Diagnostic Reagents” on January 3, 2024, along with eleven IVD related guidance. It comes as the File No.1 released
The NMPA issued the “Draft Guideline on Modification Registration IVD of In Vitro Diagnostic Reagent” on May 31, 2023, for feedback. Feedbacks need to be submitted by June 30, 2023.
The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013, with two supplemental updates in 2017 and 2020 respectively. NMPA issued the “Draft Classification
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
The NMPA issued the “Guideline on Instructions for Use of In Vitro Diagnostic Reagents (draft)” for feedback. The guideline stipulates drug information such as the intended use, test methods, interpretation
The NMPA officially published the first guideline specifically for CDx reagents, the “Guideline for Technical Review and IFU Update for Oncology CDx Based on the Same Group of Therapeutic Drugs”
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