Qujiang New District Branch Conducts Compliance Inspections on Hearing Aid Businesses

Deep News
03/10

The quality and safety of hearing aids, which are critical medical devices for restoring auditory function to individuals with hearing impairments, directly impact public welfare. To improve the operational environment for Class II medical devices, the Qujiang New District Branch of the Xi'an Market Regulation Administration conducted a comprehensive compliance inspection of hearing aid businesses in its jurisdiction on March 9. The inspection focused on three key areas: First, verifying the validity of business licenses and medical device operation filing certificates. Second, reviewing product compliance, including checking whether medical device registration certificates match the actual products, ensuring supply channels are legitimate and traceable, confirming the implementation of purchase inspection and documentation systems, and validating the completeness of sales records, product certifications, instructions, and labeling. The inspection also checked for counterfeit, substandard, or expired products. Third, evaluating operational processes and management systems, such as adherence to the "Medical Device Operation Quality Management规范," appropriate storage conditions, compliance in advertising practices, and the effectiveness of after-sales service and quality management systems. During the inspection, officials emphasized a balanced approach of regulation and service, providing legal guidance on-site to help businesses enhance compliance awareness and improve quality control. Moving forward, the administration will continue to strengthen supervision of medical device operators, implement regular risk assessments and corrective measures, and take strict action against any violations to safeguard the health rights of individuals with hearing impairments.

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