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The China Food and Drug Administration has unveiled long-awaited reforms to its medical device regulations, extending the life of product licenses, but imposing first-time fees for device registrations. Read More
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More
The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related tests off the market. Read More
European regulators have granted Edwards Lifesciences’ next-generation Intuity Elite valve system CE Mark approval, the Irvine, Calif., devicemaker said Friday. Read More