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2026 China NMPA Bluebook is here:
NMPA issued the draft standard “Medical Devices – Part 1: Application of Usability Engineering to Medical Devices” on August 28, 2025 for feedback. Feedbacks need
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2025. These updates are presented by China Med
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local
NMPA Center for Medical Device Standardization Administration released “Drug-Device Combination Products Classification Results (June 2024 to May 2025) on July 7. The document identifies 7
Thirty-six medical devices standards will take effect in July 2025, including three national standards for cardiovascular implants. These newly established or revised standards are aimed
II. Regulatory Landscape and Global Market Integration NMPA The NMPA classifies punctal plugs as Class III medical devices under the code 16-07-05, denoting the highest
Dry eye disease (DED) is a prevalent and chronic ocular condition characterized by tear film instability, ocular discomfort, and visual disturbances. With the increasing use
NMPA published the “2025 Medical Device Guidelines Revisions Plan” on May 7, 2025, in which 55 guidelines for Class III and 55 for Class II
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 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