Medical devices are classified into Classes 1 through 4: Class 1 (一般医療機器; general medical device), Class 2 (管理医療機器; controlled medical device), Class 3 (高度管理医療機器; highly controlled medical device), and Class 4 (高度管理医療機器; highly controlled medical device). Definitions are as follows...
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LEXICON
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…




