Policies
New GMP Standards: Elevating Medical Device Manufacturing to Global Excellence
NMPA published the new draft “Medical Device Manufacturing Quality Management Standards” on January 15, 2025, for feedback. The proposed revision aligns more closely with the internationally recognized ISO 13485 standard, establishing risk-based GMP principles. The document expands from 82 provisions in 2014 version to 131 provisions and incorporates nearly a decade of NMPA experience in medical device GMP inspection. Also, it defines various terms more precisely, making it more practical for implementation. See our comprehensive analysis HERE
Revised Device Regulation: A Clearer Gateway for Overseas Manufacturers Seeking Market Expansion
The NMPA issued the “Regulation on the Supervision and Administration of Medical Devices” on January 7, 2025. The key changes are manifested in registration, production, operations and use, adverse events and recalls, and legal responsibilities, many of which are attractive to foreign companies. Click HERE for more information
Fast-Track Approvals
Review Report Released for Roche’s EV Virus Detection Kit
The NMPA granted innovation approval to Roche’s Elecsys EBV VCA IgG and issued a review report.
This product is intended for the in vitro qualitative detection of EB virus (EBV) IgG antibodies (including IgG antibodies against VCA, EA, and IEA antigens, without differentiation) in human serum and plasma. It is used as an aid in diagnosing infectious mononucleosis and determining the stage of EBV infection.
The review report has four sections: product overview, pre-clinical, clinical and risk-benefit analysis. For the outline of the report, please click HERE
Featured Article
Unlocking Opportunities in China’s Ophthalmology Market: Recent Developments
As one of the fastest-growing healthcare sectors in the country, ophthalmology is driven by increasing prevalence of eye diseases, advancements in surgical and diagnostic technologies, and growing consumer demand for innovative treatments. While domestic brands are expanding rapidly, international players such as Bausch + Lomb, Alcon, and Johnson & Johnson continue to hold a competitive edge in advanced technologies and product performance. This includes sophisticated surgical instruments, high-precision diagnostic equipment, and premium intraocular lenses (IOLs) for cataract refractive surgeries. Click HERE for our comprehensive analysis