The Medical Device Division of the Market Supervision and Administration Bureau in Yuci District, Jinzhong City, Shanxi Province, recently conducted special inspections on five local in vitro diagnostic reagent distributors. This initiative was designed to strictly enforce medical device regulatory requirements, standardize business practices in the area, prevent quality safety risks, and protect public medical device safety.
The inspections comprehensively examined potential operational hazards and reinforced the primary responsibility of companies for product quality. Investigators utilized on-site verifications, document reviews, ledger checks, and personnel interviews to scrutinize critical links throughout the distribution process. Key areas of focus included the completeness and standardization of business licenses, initial supplier reviews, and purchase and sales records. The team also evaluated warehouse layouts, product classification, and labeling systems, with particular attention given to cold chain equipment operations, temperature and humidity monitoring logs, and equipment maintenance and testing.
Regulators strictly checked the configuration of cold chain transport equipment, temperature control measures, and handover records to eliminate improper transportation practices. Personnel qualifications, training, and on-the-job performance were assessed, along with the implementation of quality management systems for procurement, acceptance, storage, maintenance, and cold chain control. For any issues discovered, authorities provided on-site feedback, explained regulatory standards, and set clear rectification requirements and deadlines. All five companies received corrective notices, with follow-up managed through a checklist-based, closed-loop system.
The core goal of regulation is to compel these enterprises to fully assume their responsibilities, correct each identified problem, address management weaknesses, improve documentation, and standardize storage, cold chain, and personnel procedures. They are also required to establish routine self-inspection mechanisms to proactively identify and resolve operational risks, thereby continuously standardizing their business conduct. Moving forward, the Yuci District Bureau will maintain strict oversight of medical device quality safety, closely monitor the implementation of corrective actions from this inspection, and conduct timely follow-up checks to ensure all issues are resolved permanently without recurrence.
At the same time, the agency plans to intensify routine patrols and random inspections, focusing on key risks such as cold chain management, product traceability, and ledger standardization. Regular legal education and awareness campaigns will also be conducted to further regulate the local in vitro diagnostic reagent market and safeguard the safety and effectiveness of medical devices for the public.