The NMPA issued an inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System.
NMPA organized a remote inspection of KARL STORZ. 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. The products present potential quality and safety risks. The comprehensive assessment concludes that the company does not comply with the requirements of China’s “Medical Device Production Quality Management Standard”.
As a result, the NMPA has decided to suspend the import, distribution, and use of the High-frequency Surgery System with immediate effect, based on the Decree 739 Regulation on Supervision and Management of Medical Devices.
In September 2023, a Korean manufacturer Prestige Medicare’s pelvic organ prolapse repair system was found with defects in remote inspection. The actual production process of this product is inconsistent with that of production process flow chart, and testing is not carried out in accordance with the registered PTR (product technical requirement). The penalty was also the suspension of the import, distribution, and use.
For other inspection results, please click HERE
China Med Device Cited by RAPS on NMPA Overseas Inspection. Click HERE for the article
Click HERE for the list of devices mentioned in the 2023 National Inspection Plan