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2026 China NMPA Bluebook is here:
The Guangdong Provincial Medical Products Administration and the Guangdong Provincial Health Commission issued the “Administrative Measures for the GBA Urgently Needed Hong Kong–Macao Drugs and
NMPA released the revised Good Manufacturing Practice (GMP) for Medical Devices on November 4, 2025, also referred to as the “Specification for Medical Device Production.”
The NMPA issued the “Announcement on Adjustments to Certain Items in the Medical Device Classification Catalog” on January 4, 2026. The adjustments are aimed to
NMPA issued the “2026 Medical Device Industry Standards Revisions Plan” today on January 28, 2026. One mandatory and seventy-nine recommended standards will be revised or
In the review reports released in December 2025, eight out of ten pertained to IVD reagents, reflecting the continued advancement and regulatory scrutiny in fields
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
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
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
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