Dongyang Hengdian Town checked special custom-made dentures

 Custom dentures in direct contact with the human oral cavity, security issues have also been highly valued. Hengdian Town, Dongyang City in order to conduct a serious investigation dental clinic eligibility medical environment, the dentures Class II medical devices and other purchase channels, such as whether legal, the Food and Drug Administration (FATF) law enforcement officers launched a special inspection of the oral institutions within the jurisdiction of custom-made dentures. It is reported that the inspection object set including three dental medical institutions, 19 Dental Clinic (Health Room).

  This, the Food and Drug Administration in Hengdian focus on examination of custom oral dentures use units from legitimate production (business) enterprises to customize or purchased whether audit corporate certificates of qualification and filing retention, product quality acceptance, use management system, relevant records whether a true and complete audit and retained for future reference; whether the use of oral dentures "medical device product registration card"; purchased drugs and Medical Devices whether to save the negotiable instruments and do the inspection records exists from illegal the channels purchase behavior of the medical devices and other content.

Law enforcement officers on the spot unable to to provide dentures producers "Medical Device Manufacturing Enterprise License", units of the product registration card, and ordered its rectification, and medical institutions must be collected and retained in the supply unit and the legal qualification of the products, the establishment of a true and complete the use of record, the record shall contain the patient's name and contact information, physician name, custom type, custom time, product lot number. Requirements Contact customized dentures salesman to further regulate the the dentures production enterprise custom single batch custom dentures product package labels or brochures, etc., to establish a true and complete file, to ensure the traceability of such products, the prevention the black processing point or undocumented enterprise products into the market, to ensure that people with mechanical safe and effective.  

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