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2026 China NMPA Bluebook is here:
Optical Coherence Tomography (OCT) has become an indispensable imaging tool in ophthalmology, offering high-resolution, non-invasive, real-time cross-sectional visualization of ocular tissues. Since its introduction in
Accurate medical device classification is the foundation of regulatory compliance, registration strategy, clinical planning, and market access in China. NMPA Classification Catalog was published in
Starting January 1, 2026, NMPA will further expand its pre-submission technical consultation program for medical device registration. In addition to the National Center, three regional
NMPA published 39 medical devices final guidelines on December 1, 2025. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device
Cataract remains one of the most common ophthalmic diseases in China, largely driven by the country’s rapid demographic transition toward an aging society. Epidemiological reports
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your
The China State Council released the “Administrative Regulation on Clinical Research and Clinical Transformation of New Biomedical Technologies” on October 10, 2025, which will be
NMPA published seven medical devices draft guidelines on November 11, 2025. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device
Fifteen newly established or revised industry standards were released by NMPA on October 30, 2025, to guide manufacturers for type testing, pre-clinical, clinical studies, and
The NMPA published its revised “Good Manufacturing Practice Specification for Medical Device Production” on November 4, 2025, a major update to the original 2014 regulation.
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your
NMPA released the industry standard “Test method for sensing and feedback performance of the interactive neurostimulator for medical equipment using brain-computer interface technology” on September