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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
To respond to the emerging trend of adopting software in health care, China has told its regulators what to look for when approving software and how evaluating its quality and
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
AI Guidelines 2023 The NMPA (National Medical Products Administration) affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform has provided a comprehensive summary of six pivotal AI-related guidelines released in 2023.
NMPA released the “Clinical Evaluation Guideline on Artificial Intelligence-assisted Detection Medical Devices (Software)” on November 7, 2023. The guideline refers to FDA guidance of “Computer-Assisted Detection Devices Applied to Radiology
The NMPA published four guidelines for AI software on July 10, 2023, propelling China to be the leader in the AI applications. Full List of Guidelines for AI Software The
The NMPA published the “Key Points of Ultrasound Imaging Artificial Intelligence Software (Process Optimization)” on July 10, 2023, to direct related manufacturers for type testing, clinical evaluation, and regulatory submission.
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