To standardize the medical device market order within its jurisdiction, enhance the quality management level of operating and using entities, and effectively guarantee the safety and efficacy of medical devices for the public, the Taocheng District Branch of the Hengshui Municipal Market Supervision and Administration Bureau in Hebei Province recently conducted comprehensive inspections of medical device distributors and users in the area. The focus was on identifying potential risks and hazards and reinforcing primary responsibility.
Law enforcement personnel strictly adhered to legal requirements, including the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Operations." They employed a combined approach of on-site verification and record review to conduct thorough and meticulous checks around key processes.
In the distribution segment, inspections prioritized verifying whether entities were engaged in operations beyond their approved scope or distributing Class III medical devices without proper licenses. Officials meticulously examined the completeness and standardization of purchase acceptance records, assessed whether storage and transportation conditions met standard requirements, and confirmed the availability and validity of product qualification documents, thereby building a robust quality and safety defense from the source.
For the usage segment, the focus was on whether user entities had established and strictly implemented management systems, including pre-use checks, regular maintenance, and procedures for scrapping and destruction. This ensures full traceability and safety control throughout the entire clinical use process of medical devices.
Concurrently, the branch investigated medical device advertising within its jurisdiction, cracking down on illegal activities such as false宣传 and misleading consumers to continuously purify the market consumption environment.
The Taocheng District Branch will use this special inspection as an opportunity to persistently intensify market supervision of medical devices. It plans to conduct irregular "look-back" reviews of problem rectifications, continuously improve the standardization level of medical device operations and usage in the area, effectively strengthen the safety防线 for public medical device use, and safeguard consumers' legitimate rights and interests according to law.