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NMPA Roundup January 2026

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in January 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies China Expands Pre-Submission Technical Consultation for Device Registration: What Overseas Manufacturers Need to Know Starting January 1, 2026, NMPA will […]


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Clinical Applications of Optical Coherence Tomography (OCT) in Ophthalmology: with MIOCT and Ocular Injection in Foc...

OCT-Guided Ocular Injections Intravitreal injections are a cornerstone of modern retinal therapy, used to deliver anti-VEGF agents for AMD, diabetic macular edema, and other retinal disorders. Although the procedure is generally safe, complications such as retinal injury, vitreous hemorrhage, or uneven drug distribution remain concerns. OCT guidance can enhance injection safe...


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Clinical Applications of Optical Coherence Tomography (OCT) in Ophthalmology: with MIOCT and Ocular Injection in Foc...

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 the early 1990s, OCT has rapidly evolved and expanded its clinical applications from retinal diagnostics to surgical guidance and therapeutic monitoring. In op...


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NMPA Device Classification: A Rapidly Searchable and Updated Catalogue Available Now

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 August 2017. After the release, several modifications have been made and many classification results have been issued reflect the latest technology and regulatory changes. China Me...


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China Expands Pre-Submission Technical Consultation for Device Registration: What Overseas Manufacturers Need to Know

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 branches—Beijing-Tianjin-Hebei, Central China, and Southwest China—will provide structured pre-acceptance technical consultations, joining the already established Yangtze River Delta and Greate...


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