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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
The FDA handed Siemens Healthcare Diagnostics a Form 483 for violations including inadequate documentation of corrective actions and substandard complaint-handling procedures. Read More
Devicemakers doing business in the Czech Republic face a steeper regulatory burden than before, thanks to regulations that took effect April 1. The new law requires devicemakers, importers and distributors to archive product safety documentation for five years and subject products to regular validation testing. Read More
A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter. Read More
Manufacturers planning to participate in the Medical Device Single Audit Program should first study up on Australian and Brazilian regulations, an official at the first company to go through a MDSAP audit tells GMP. Read More
The Indian government is developing a medical device postmarket surveillance system, following a series of high-profile incidents in which faulty products harmed patients. Read More
The FDA handed Encompas Unlimited a warning letter for failures in quality control, implementation of medical device reporting procedures and incomplete device history records.
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