Russia signed an agreement with Brazil, Argentina and Mexico to share best practices and information on quality, efficacy and safety of medical products as well as adverse event information, on the first day of the International Medical ... Read More
The IMDRF’s Medical Device Clinical Evaluation Working Group, led by China, released three related consultation documents aimed at integrating regulations across regions to better evaluate clinical data and reduce redundant clinical tria... Read More
The FDA warned Inova Genomics Lab for marketing pharmacogenomic and whole gene sequencing tests without the agency’s approval or clearance. Read More
Specification developer Circulatory Technology failed to submit medical device reports within 30 days of receiving complaints that its Better Bladder device failed during use, collapsing as a result of leaks, an Aug. 22 to Sept. 26, 2018... Read More
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