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Device failures and inadequate complaint handling procedures resulted in a Form 483 for Biogenex Laboratories, a maker of automated molecular pathology workstations. Read More
Bayer Healthcare’s Essure female contraceptive is facing new FDA scrutiny in the wake of a citizen petition alleging data integrity breaches on the part of the manufacturer. Read More
While China’s year-old medical device regulations require clinical trials for Class II and Class III devices, there are some exceptions and regulators are in the process of finalizing guidance to help companies take advantage of them, an expert says Read More
The China Food and Drug Administration has issued 90 industry standards — 14 mandatory and 76 recommended — covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry. Read More
The International Medical Device Regulators Forum has issued a proposed document explaining how to use quality management systems to regulate software as medical devices. Read More