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.
Policies
China Revised GMP: What Overseas Manufacturers Should Know About the 2025 NMPA Device Manufacturing
The NMPA published its revised “Good Manufacturing Practice Specification for Medical Device Production” on November 4, 2025, a major update to the original 2014 regulation. Referenced to ISO 13485, EU MDR, and FDA QMSR/21 CFR 820, the revised GMP reflects China’s effort to integrate international concepts such as total lifecycle control, risk-based quality management, and digital traceability. For our comprehensive analysis, please click HERE.
Regulation on Stem Cells and Gene Editing to Take Effect in May 2026: Fully Applicable to Foreign-Invested Institutions
The China State Council released the “Administrative Regulation on Clinical Research and Clinical Transformation of New Biomedical Technologies” on October 10, 2025, which will be effective on May 1, 2026. This landmark regulation was signed by China Premier Li Qiang. It establishes a unified, stringent management framework for all activities involving cutting-edge biomedical technologies within China. Importantly, it applies to all projects conducted “within the territory of China,” including those operated by foreign-invested institutions.
Click HERE for the requirements of clinical trial and key takeaways for the sponsor.
Guidelines & Standards
Seven NMPA Draft Guidelines Released in a Single Day
NMPA published seven medical devices draft guidelines on November 11, 2025. They are aimed to facilitate manufacturers with clarity in registration process.
By simultaneously issuing guidance documents across diverse product categories—from imaging components and minimally invasive surgical systems to ECMO and urological lasers—NMPA is clearly prioritizing alignment with international regulatory expectations, particularly in areas requiring high clinical and engineering rigor. Click HERE for more information
NMPA Released Fifteen Standards in a Single Day
Fifteen newly established or revised industry standards were published on October 30, 2025, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. The standards will be implemented on November 1, 2026. Click HERE for the full list
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.