As the Spring Festival approaches, the quality and safety of medical devices represent a critical line of defense in protecting public health. In recent days, the Market Supervision Authority of Ningyang County, Shandong Province, has innovated its regulatory approach by activating a three-tier coordination mechanism involving departments, enforcement teams, and local offices. This initiative involves a comprehensive special inspection of the medical device market ahead of the holiday, aiming to build a robust barrier for medical device quality and safety through precise supervision, strict law enforcement, and considerate services, ensuring the public enjoys a safe and peaceful Spring Festival.
"In previous holiday periods, there have been numerous complaints regarding household physiotherapy devices, blood pressure monitors, and similar products. This time, we are focusing our efforts precisely, targeting frequent violation types, high-incidence areas, and common product categories from past cases to conduct hazard inspections," explained Liu Hua, Head of the Medical Device Supervision and Management Department of the Ningyang County Market Supervision Authority. This special inspection breaks down barriers between departments, enforcement teams, and grassroots supervisory offices by forming joint inspection teams. It implements a regulatory model characterized by "division of labor and collaboration, vertical and horizontal coordination, and comprehensive coverage" to ensure no regulatory blind spots and no overlooked hazards.
Addressing the characteristic surge in sales of household medical devices during the Spring Festival period, the focus is on product categories with high public concern and frequent usage. These include household monitoring devices such as health smart bands/watches, electronic blood pressure monitors, and blood glucose meters; decorative contact lenses like cosmetic colored lenses; and various popular holiday medical devices such as household physiotherapy apparatus and massage equipment.
Law enforcement officers have深入 inspected key business premises within their jurisdiction, including aesthetic medical institutions, retail pharmacies, and optical stores. They conducted item-by-item checks on product procurement documentation, incoming goods inspection records, storage environmental conditions, and quality management during sales and usage. They rigorously addressed illegal activities such as operating without proper qualifications, non-standard supply channels, substandard storage conditions, and incomplete product labeling or instructions. Officers provided hands-on guidance to businesses on standardizing record-keeping and optimizing storage conditions, strictly controlling medical device quality at the source.
While supervision is stringent, services are delivered with consideration. To build a co-governance structure for medical device safety, alongside strengthening special inspections, the Ningyang County Market Supervision Authority has simultaneously streamlined complaint and reporting channels. It strictly implements a 24-hour duty system during the holiday period, ensuring the 12315 complaint platform is responsive around the clock. For any medical device quality issues or leads from public complaints and reports, the authority adheres to a "immediate handling upon receipt, rapid investigation and disposition" approach, promptly addressing public concerns and effectively safeguarding consumer rights and interests.
Concurrently, during inspections, law enforcement personnel proactively publicize laws and regulations related to medical device safety to both businesses and the public. They explain product selection techniques and usage precautions, guiding businesses towards lawful and trustworthy operation, while enhancing the public's self-protection awareness and ability to identify counterfeit products.
As of now, this operation has involved dispatching law enforcement personnel over 167 times. Inspections have covered 12 aesthetic medical institutions, 35 retail pharmacies, and 17 optical stores, identifying 8 various potential risks and hazards. Five rectification orders have been issued, all specifying clear deadlines, responsible persons, and rectification standards, forming a closed-loop management process of "inspection - rectification - follow-up review." This has effectively mitigated a batch of potential medical device safety risks during the holiday period and standardized the operational order of the medical device market within the jurisdiction.