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 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 Greater Bay Area centers. This move is designed to improve regulatory efficiency, consistency, and predictability for manufacturers, including overseas companies entering the Chinese market. For more information, click HERE
NMPA Device Classification: A Rapidly Searchable and Updated Catalogue Available Now
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 Med Device, LLC has consolidated the catalogs and results to a Rapidly Searchable Classification Catalogue. Covering thousands of device entries, the Excel-based catalogue consolidates official classification information released by NMPA and presents it in a format that is optimized for fast retrieval, comparison, and decision-making. For more information, click HERE
Guidelines & Standards
NMPA published 39 medical devices final guidelines on December 1, 2025. Covering a broad spectrum of medical devices—from cardiovascular monitors, endoscopic and laparoscopic instruments, and physical therapy equipment to ophthalmic analyzers, obstetrical and gynecological devices, and immunoassay reagents, they are aimed to facilitate manufacturers with clarity in registration process. For the full list please click HERE
Featured Article
Clinical Applications of Optical Coherence Tomography (OCT) in Ophthalmology: with MIOCT and Ocular Injection in Focus
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. For our comprehensive review on two major technologies of OCT and the manufacturers, please click HERE
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.