According to a recent announcement, the Taishan District Market Supervision Bureau in Shandong Province has initiated the first round of provincial-level special sampling inspections for medical devices in 2026, adhering to a problem-oriented and targeted regulatory approach. This inspection campaign focuses specifically on medical facilities with high usage volumes, frequent consumer complaints, and significant potential risk exposures, aiming to strengthen the safety net for medical devices through precise sampling methodologies.
Emphasizing targeted oversight over broad-brush inspections, the bureau has identified key medical institutions for sampling based on historical regulatory data and complaint records. The inspection scope covers commonly used medical products with high public safety concerns, including disposable light-shielding infusion sets, disposable venous blood collection needles, and disposable sterile urinary catheters.
The inspection process follows strict standardized protocols throughout all stages. Enforcement officers meticulously verify operational licenses, product registration certificates, and procurement documentation while conducting standardized procedures for sample collection, sealing, and labeling. Detailed sampling records ensure full procedural compliance and complete traceability.
The bureau emphasizes simultaneous inspection and corrective actions, mandating immediate risk control measures such as product removal, quarantine, and recalls for any non-compliant items identified during sampling. Legal responsibilities are reinforced through regulatory education and warning sessions for medical institutions, urging strict adherence to quality control systems including procurement verification, documentation management, and product traceability.
To date, the inspection has covered three product categories—disposable light-shielding infusion sets, disposable venous blood collection needles, and disposable sterile urinary catheters—totaling 125 units sampled. Moving forward, the Taishan District Market Supervision Bureau will continue refining its targeted medical device supervision model, enhancing routine oversight of key sectors and entities to strengthen quality assurance mechanisms.
Public participation in medical device safety supervision is encouraged through reporting channels such as the 12345 government service hotline for identifying regulatory violations in medical device usage.