Policies
As China Overhauls GMP, KARL STORZ’s High-frequency Surgery System Faces Import Suspension Over QMS Failures
The NMPA issued a remote inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System. It was found that the company “has deficiencies in its quality management system regarding product software version control, analysis and handling of adverse events, and performance of the management representative. As a result, the NMPA has decided to suspend the import, distribution, and use of the High-frequency Surgery System with immediate effect.
The suspension of KARL STORZ’s product comes at a critical juncture as China transitions to its revised Good Manufacturing Practice (GMP) for Medical Devices (Announcement No. 107, 2025), which will fully replace the 2014 framework starting November 1, 2026.
For our comprehensive analysis, please click HERE
Twenty-five Pilot Hospitals in Guangdong: Strengthening Synergy with the GBA Urgent Use Policy
The Health Commission of Guangdong Province, together with the provincial healthcare security and medical products authorities, has jointly announced the first batch of pilot hospitals for international medical services. A total of 25 hospitals has been selected. This milestone marks the official implementation of Guangdong’s international medical service pilot program.
The selected hospitals represent a diverse mix of top-tier public hospitals, renowned traditional Chinese medicine institutions, regional leaders, and high-quality private hospitals. For the list of hospitals and the key initiatives taken by them, please click HERE
2026 National Inspection Plan Released: Pay Attention to Your Device Standards
The plan covers 76 medical devices and IVDs. NMPA lists the inspection items for each product. For the devices list, click HERE
Guidelines & Standards
On March 24, 2026, NMPA published draft versions of registration review key points drafts for 18 medical devices. Once finalized, the documents aim to provide manufacturers with clearer guidance on testing, clinical evaluation and registration requirements.
This marks the second time that feedback has been sought for the key points concerning tumor gene variation detection reagents. For more information, please click HERE
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.