The NMPA conducted a “fly inspection”, also known as an unannounced inspection, on Chenfang Sichuang Technology Co., Ltd. According to the notice published on April 17, 2023, the inspection found that the quality management system of the enterprise mainly has the following defects:
Institution and Personnel
The management representative of the enterprise failed to identify the relevant requirements of the “Independent Software of the Appendix of the Medical Device Quality Management Specification” and improve the quality management system in accordance with the actual situation of the company’s products, which does not meet the requirements of the management representative in the “Medical Device Production Good Management Specification”.
The enterprise inspectors failed to answer the questions on-site, on voltage tolerance test and leakage current test.
Design and Development
On March 19, 2021, the company replaced the KF-2412P product screen of the long-term Holter recording and analysis system with a color LCD screen, and on October 10, 2019, the data line interface was changed from miniUSB to Type-c. Although the design development change control process was initiated, the product quality risks that may be brought by it were not identified and fully verified.
The enterprise cannot provide and open the software configuration management tool on site, cannot provide the software update control file and software update development plan, software defect management tool and its records, and only provides the “Description of Software Version”.
The product, marked in warehouse as “dynamic blood pressure recording and analysis system”, with specification model of “CF3001”, serial number of “AXM090426”, and the version number of “Release: V6, Complete: V6.8.25”, is inconsistent with the technical requirements of the product which is marked “126.96.36.199 Embedded Software (ie, logger-side software) Software Identification – Software Version: Release Version is V6.08”.
The enterprise can resume production only after completing all project rectification and passing the review and reinspection.
If you have any questions on “Good Manufacturing Practice for Medical Devices” and the “Good Manufacturing Practice for Independent Software” or what happens during an NMPA unannounced inspection, please contact us at our email info@ChinaMedDevice.com.