Since 2011, Shanxi Province Food and Drug Administration to ensure that the public around the safe and effective use of medical devices,digital thermometer enhanced the daily supervision of administrative examination and approval and production, strict quality and safety of medical devices the source of the work.
digital thermometer manufacturer Medical Devices Bureau strict approval procedures and business critical review of each product and business aspects of fraud, non-conforming firm will not be approved. Up to now, the province registered Class II Medical Device Product 8; Medical Device Manufacturing Enterprise License issued 13; Medical Device Distribution Enterprise License issued 314; advertising a medical device approval; digital blood pressure monitor off 14 medical device enterprises.
Council in accordance with medical device manufacturers routine supervision and inspection requirements of the province's medical device manufacturers often conduct supervision and inspection. As of June 15, 2011, more than 310 people out of law enforcement personnel, 86 medical equipment for manufacturers of system operation for daily supervision and inspection of the 30 problems of the enterprise made ??a rectification requirements and a deadline for rectification of the eight companies carried out for investigation.
Board that it would further strengthen the supervision of medical equipment sources, standardized medical device manufacturer producing behavior, to achieve within the jurisdiction of all medical device manufacturers 100% coverage of routine supervision and inspection, to achieve high-risk medical devices during business enterprises covered by the daily supervision and inspection rate of 100% in order to promote medical device manufacturers to continuously improve quality management level, to ensure the quality of safe and effective medical devices.