In order to further standardize the order of medical device manufacturers in Harbin, strengthen the supervision and management of the source of medical device production, and severely crack down on violations of laws and regulations, Harbin Food and Drug Administration will carry out special inspections of medical device manufacturers from April 5. The special inspection will continue until the end of October. If the public finds that the medical device manufacturer violates the rules, they can call 12331 to report the complaint.
It is understood that this special action focuses on checking whether medical device manufacturers establish a quality management system based on the "Quality Management Standards for Medical Device Production"; whether the quality management system is in place; whether the procurement, production, inspection, and sales records are complete; inspection instruments and Whether the equipment, product inspection and other aspects meet the standards. Comprehensively check the quality risks and safety hazards in the production process, standardize production behaviors, focus on solving current problems, investigate and deal with violations of laws and regulations, and improve the quality and safety of medical devices. This centralized inspection will investigate and deal with violations of laws and regulations, smash a batch of illegal production of "black dens" and expose a group of illegal enterprises. The bureau will supervise the inspection team from time to time to supervise the inspection of the production enterprises under the jurisdiction of the district, county (city) bureau and development division bureau, and summarize and evaluate the inspections of the district, county (city) bureaus and development division bureaus. The results were included in the year-end evaluation of medical device supervision work.
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