NMPA Conducts Surprise Inspections on 10 Medical Device Firms, Identifies 106 Quality Management Deficiencies Ahead of IPO Filing

Jan 03, 2024 17:58 CST Updated 17:58

Instrument Family

Medical Device Media Reporting Pioneer

Share Professional Medical Device Knowledge

Source:NMPA

Notice on the Status of Unannounced Inspections of Medical Devices (No. 5, 2023)

To strengthen the supervision and management of medical devices and ensure their safety and effectiveness, based on the "Regulations on the Supervision and Administration of Medical Devices," the "Measures for the Supervision and Administration of Medical Device Production," the "Measures for Unannounced Inspections of Drugs and Medical Devices," the "Medical Device Production Quality Management Standard" and its related annexes, as well as the "Notice of the China Food and Drug Administration on Issuing the Guiding Principles for On-site Inspection of the Medical Device Production Quality Management Standard and Other Four Guiding Principles" (CFDA [2015] No. 218), and in accordance with the 2023 medical device inspection work plan of the National Medical Products Administration, the Verification Center conducted unannounced inspections of medical device manufacturers from April to November 2023. It was found that ten enterprises, including Hunan Haipuming Technology Co., Ltd., did not comply with the requirements of the "Medical Device Production Quality Management Standard" and its related annexes. For details, see the attached table.

Regarding the non-conformities identified during the inspection, the relevant provincial, autonomous region, and municipal drug administration bureaus should urge the companies to rectify within a specified timeframe. The companies are required to assess the safety risks of their products, and for those with identified safety risks, recall the relevant products in accordance with the "Measures for the Administration of Medical Device Recalls." After the companies complete the rectification, the relevant provincial drug administration bureaus should promptly organize confirmation of the rectification status and report the confirmation results to the Center for Food and Drug Inspection and Verification of the National Medical Products Administration.

Attachment:Summary of the Third Batch of Medical Device Flight Inspections by the Verification Center in 2023

National Medical Products Administration Inspection Center

December 25, 2023