Policies
NMPA Final Inspection Guideline for Medical Device GMP: 39 Critical Items Overseas Manufacturers Must Address
The NMPA issued the “Guideline for Inspection under the Medical Device Good Manufacturing Practices” on September 15, 2026, which will take effect on November 1, 2026. The final guideline follows the June 9, 2026 draft and marks a further step toward risk-based, lifecycle-oriented regulation of medical device manufacturing in China.
The document converts the China new GMP into 200 inspection items: 39 critical items (***), 88 major items (**), and 73 general items (*). Manufacturers should conduct gap analyses against the final requirements, update their quality management systems (QMS), and prepare for both manufacturing license inspections and post-market surveillance inspections.
For our comprehensive analysis, please click HERE
China Issued Two AI Medical Device Draft Guidelines
The NMPA released the Draft Guideline on Artificial Intelligence Medical Devices and Draft Guideline on Clinical Evaluation of Artificial Intelligence Multi-Disease Auxiliary Decision-Making Medical Device on September 14 and 15 respectively. Together, they mark an important step in China’s AI medical device regulation. They show that China is moving from general AI software principles toward a more layered system: a horizontal lifecycle and algorithm framework, plus vertical clinical evaluation rules for complex AI products.
For key points of the two guidelines and the implications on foreign manufacturers, click HERE
Guidelines & Standards
NMPA published 130 medical devices draft guidelines on September 1, 2026 for feedback. Feedbacks need to be submitted by October 8, 2026. Among them are 16 IVDs, 55 non-active, and 59 active devices. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission. Click HERE for the full list of guidelines
GMP & GVP
China’s 2026 New GMP: Will Your Quality System Pass the NMPA Inspection?
The revised China Medical Device Good Manufacturing Practices (GMP), published in November 2025, will take effect on October 1, 2026. Following the release, NMPA has issued comprehensive suite of GMP and GVP (Good Vigilance Practices) documents, moving China’s post-market oversight from a reactive, issue-based approach to a continuous and rigorous inspection system.
For our comprehensive analysis on inspection results, inspection guideline, GVP guidelines and annual AE report, please click HERE
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.