Recently, the Market Supervision Administration of Jiangyan District in Taizhou City, Jiangsu Province, conducted a special inspection targeting medical device sales enterprises. This initiative is a significant measure to continuously deepen quality supervision across the entire supply chain and lifecycle of medical devices. By mobilizing efforts from both enterprises and regulators, the aim is to further tighten the safety net within the district's medical device sales sector.

Strengthening self-inspection and correction to solidify the foundation of primary responsibility. Following prior promotional notices issued via the bureau's official WeChat account and work groups, timely follow-up was conducted to guide and urge all units to carry out self-assessments of their medical device sales quality management systems. Problems identified during self-inspection were addressed with corrective measures, and self-assessment reports were submitted promptly. To date, 630 medical device sales enterprises in the district have completed their self-assessments. Among them, 23 enterprises have voluntarily applied to deregister their sales qualifications, and 10 have been listed in the abnormal operations directory.

Deepening compliance checks to ensure product market entry standards. Building on the enterprises' self-assessments, specialized inspections of medical device sales companies were carried out. The focus was on a comprehensive review of business qualifications, personnel allocation, warehousing and transportation, and the operational status of quality management systems. Each enterprise was verified to ensure it had legally obtained the necessary business licenses or filing certificates, that key personnel were performing their duties on-site, and that there were no instances of operating beyond permitted scopes or unauthorized changes to warehouse locations. Furthermore, a full-chain traceability inspection was conducted on procurement, acceptance, and sales processes. As of now, 24 sales enterprises have been inspected.

Implementing closed-loop problem rectification to drive continuous enterprise improvement. Regarding issues identified during this special inspection, the principle of "combining inspection with guidance, and promoting rectification alongside standardization" was upheld. Notices ordering corrections were issued individually to relevant enterprises, specifying deadlines and detailed requirements. A problem ledger was established to manage resolution tracking. Currently, 9 such correction notices have been issued. After the rectification deadlines expire, follow-up reviews will be organized at an appropriate time. Enterprises that fail to rectify issues adequately or refuse to comply will face serious legal and regulatory consequences.

Moving forward, the bureau will continue to intensify oversight, establish and improve long-term regulatory mechanisms, and strive to build a sound co-governance framework characterized by clear enterprise responsibility, effective departmental supervision, industry self-discipline, and social oversight. Through the strictest supervision and most robust measures, the administration is committed to fully safeguarding public safety in the use of medical devices.