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2026 China NMPA Bluebook is here:
The NMPA National Institutes for Food and Drug Control released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing
NMPA Center for Food and Drug Inspection issued the “Notice of Unannounced Inspections Results in 2nd batch of 2025” on August 15, 2025. The unannounced
The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7,
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC,
NMPA Center for Medical Device Standardization Administration released “Drug-Device Combination Products Classification Results (June 2024 to May 2025) on July 7. The document identifies 7
NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The new guideline
The NMPA granted innovation approvals to Inari Medical’s FlowTriever Retrieval/ Aspiration System and issued a review report. The published review reports like this one serve
NMPA published a draft document “Implementation Guideline for the Self-Testing Requirements of Medical Device Registration” on June 26, 2025 for feedback. Feedbacks need to be
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2025. These updates are presented by China
What Devices Received HUD Designation As examples, the following devices, categorized by indications, have been designated HUD status: Indication Device Manufacturers Year of HUD Designated
FDA’s Humanitarian Use Device (HUD) program offers a crucial lifeline to patients with rare conditions who might otherwise be left behind in the march of
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents” on June 24, 2025, which exempts 445 IVDs from clinical trials, including 27