Category: NMPA (CFDA) Updates

NMPA published the seven IVD reagents guidelines on March 31, 2025. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process: Regulatory Advancements The 2025

Cataracts remain one of the leading causes of vision impairment worldwide, particularly affecting the aging population. In China, statistics show that 27.45% of people over the age of 50 are

The NMPA released a notice “Announcement on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices in China” on 18 March, 2025. Building on the 2020

NMPA issued a notice on March 17 to solicit the content input on four registration review guidelines. “Domestic and international manufacturers, research institutions, and clinical institutions with relevant work experience

NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” on March 12, 2025. The trial version was released in June 2024. For an English copy of the Inspection

China has implemented stricter requirements over medical device manufacturing and quality systems. Analyzing China’s 2024 inspection data for overseas manufacturers reveals three key developments: heightened post-pandemic scrutiny, the growing reliance

NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” on March 12, 2025. The trial version was released in June 2024. For overseas medical device companies looking to

The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products and newly developed medical devices,

The NMPA granted innovation approvals to Medtronic’s renal denervation device and issued a review report. This is the sixth report published this year for imported devices, after those from Medtronic

The NMPA granted innovation approval to Ivantis, Inc.’ hydrus microstent and issued a review report. This is the fifth report published for overseas manufacturers, after Medtronic, CarboFix Orthopedics, Intuitive Surgical

The NMPA Medical Device Standardization Administration issued the “First Batch of Medical Device Classification Results for 2024” on April 4, 2024. The document identifies 57 Class III, 101 Class II

The NMPA granted innovation approvals to Israeli company CarboFix Orthopedics’ carbon fiber polyetheretherketone (PEEK) osteosynthesis plate system and issued a review report. These published review reports serve as important references