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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
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 Class II devices. Implementing risk-based
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 “Implementation Rules for the Priority Approval Review of Medical Devices” on April 18, 2025. The document is based on the “Medical Devices Priority Approval Review Procedures” effective
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 remarkable effectiveness and diverse applications.
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 high-risk devices and are subject
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 capabilities, 3D printing is now
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 Devices Review Procedures” issued in
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