CMD Blogs

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