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2026 China NMPA Bluebook is here:
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2025. These updates are presented by China
What Devices Received HUD Designation As examples, the following devices, categorized by indications, have been designated HUD status: Indication Device Manufacturers Year of HUD Designated
FDA’s Humanitarian Use Device (HUD) program offers a crucial lifeline to patients with rare conditions who might otherwise be left behind in the march of
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents” on June 24, 2025, which exempts 445 IVDs from clinical trials, including 27
In recent decades, the widespread application of dental implants in the field of dentistry has significantly improved the quality of life for countless edentulous patients.
The NMPA granted innovation approvals to Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV-ICD) and issued a review report. The published review reports like this one serve
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
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in June 2026. These updates are presented by China Med
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
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices” on May 13, 2025, which newly-includes 27 medical devices, including 7 Class III and 20