To ensure public safety in the use of medical devices and crack down on illegal activities in the sector, the Yuehu District Market Supervision Bureau in Yingtan, Jiangxi, has launched a comprehensive quality and safety risk inspection campaign targeting medical device enterprises. The inspection focuses on four key areas to ensure thorough and detailed oversight.
First, the bureau verifies business premises and operational qualifications, checking whether the registered addresses of stores and warehouses match licensing records, confirming legal business credentials, identifying any unauthorized operations, and ensuring quality management personnel are fulfilling their duties.
Second, the inspection scrutinizes sales compliance, particularly for medical devices classified as "for medical institution use only" or labeled "not for consumer self-use" in the Medical Device Classification Catalog, to prevent illegal direct sales to individuals.
Third, the bureau examines procurement and sales records, assessing the authenticity, completeness, and traceability of transaction documentation, and verifying consistency between invoices, accounts, and inventory to ensure legal sourcing and clear distribution channels.
Fourth, product information is verified, including the validity of registration certificates, filing documents, and compliance of labels and instructions to eliminate false or misleading advertising.
Statistics show that, so far this year, the bureau has inspected 79 medical device enterprises, deployed 178 enforcement personnel, identified 34 issues, and issued 28 corrective notices. Moving forward, the bureau will focus on rectification follow-ups, conducting re-inspections while encouraging self-correction by enterprises alongside regulatory spot checks. This dual approach aims to enhance operational standards in the sector.
Additionally, regular risk inspections and public awareness campaigns will be conducted to strengthen corporate responsibility and public safety awareness, ensuring sustained market order and reinforcing medical device safety in the region.