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2026 China NMPA Bluebook is here:
The NMPA granted innovation approval to Mevion Medical System’s proton therapy system and issued a review report on December 4, 2025. The published review reports
The General Office of the State Council issued the “Opinions on Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of
NMPA Center for Food and Drug Inspection released the “Key Points for the Inspection of Real-World Studies on Medical Devices (Draft)” for feedback on December
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
Case Study: Percutaneous Coronary Intervention (PCI) The centralized procurement reforms under the DRG/DIP framework have significantly impacted the costs associated with Percutaneous Coronary Intervention (PCI)
DRG (Diagnosis-Related Group) and DIP (Diagnosis-Intervention Packet) have been introduced since 2021 as payment models implemented by the Chinese healthcare system, aiming to standardize and
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in November 2024. These updates are presented by China Med
Under China’s regulatory framework for medical devices, innovative neurosurgical devices, due to their technical complexity and high application risks, must undergo stringent approval processes. This
Thirty-four newly established or revised industry standards were released by NMPA on October 8, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and
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
The NMPA granted innovation approval to Boston Scientific Neuromodulation’s DBS directional lead and issued a review report on November 6. The published review reports like
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” on November 5, 2024, which newly-includes 387 IVDs. Feedback needs to be