Bio News
The Ministry of Food and Drug Safety published three guidelines to support South Korean medical device manufacturers seeking to expand overseas. The guidelines outline the audit criteria and response methods needed to obtain certification for manufacturers of general-purpose electrosurgical units, biomaterials for tissue repair, and general-purpose ultrasonic imaging diagnostic devices. MFDS said it expects the materials to strengthen domestic manufacturers’ ability to respond to audits and help them enter overseas markets.
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biobookmedia@biobook.co.krRoche’s New Drug for Uveitic Macular Edema Faces FDA Decision in July 2027
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