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2026 China NMPA Bluebook is here:
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
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 “Implementation Rules for the Priority Approval Review of Medical Devices” on April 18, 2025. The document is based on the “Medical Devices
In recent years, active devices based on laser, ultrasound, and radiofrequency technologies have gained significant popularity in the field of aesthetic medicine due to their
NMPA Regulations for AM Medical Devices NMPA places high importance on the regulation of 3D-printed medical devices. Custom AM implants typically fall under Class III
Additive Manufacturing (AM), or 3D printing technology, is triggering a profound technological revolution in the global orthopedic field. With its personalized, precise, and rapid manufacturing
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