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2026 China NMPA Bluebook is here:
NMPA published the “Implementation Rules for the Special Review of Innovative Medical Devices” on April 18, 2025. The document is based on the “Innovative Medical
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
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
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in April 2025. These updates are presented by China Med
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,
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
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
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
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
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in March 2025. These updates are presented by China Med
Devices and Equipment for Cataract Treatment The success of cataract surgeries hinges on the use of advanced surgical equipment. The main technology driving cataract surgeries
Introduction China’s healthcare market, one of the largest and most rapidly growing in the world, presents numerous opportunities for foreign manufacturers, particularly in specialized fields