Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
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 type testing or significant burden
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 drug-led combination products and 46
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 to facilitate manufacturers with local
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 level of regulatory scrutiny. Specialized
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 of digital screens, aging populations,
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 devices are affected. The revisions
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 partner in Chinese market access.
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