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2026 China NMPA Bluebook is here:
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
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
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,
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
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 Guidelines The guidelines are prepared
3. Clinical Evaluation Strategies Clinical studies are the decisive point for the registration of innovative Class III devices. The NMPA reports provide clear examples of two major pathways: 3.1 Superiority
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 indicate that more than 80%
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 partner in Chinese market access.
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 effective on May 1, 2026.
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 Guidelines The guidelines are prepared
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 regulatory submissions. The standards will
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. Referenced to ISO 13485, EU