韓国MFDS：医療機器登録

Which MFDS route fits your device? South Korea sorts devices into four risk classes, and the class decides who reviews your file, how long it takes, and what it costs. Class I devices are notified, on a five-day clock. Most Class II devices are certified by NIDS after a technical document review. Class III and IV need MFDS approval: 65 days for technical documents, or 80 with clinical data, not counting weekends or public holidays. For a foreign maker, the license sits with a Korean importer, who must hold an import business license. You also need a Korean GMP certificate, valid three years, Korean labeling, and renewal every five years. And renewal is not automatic. If a device was not made or imported during those five years, its license cannot be renewed, except in a few listed cases. Start with three things. One: confirm the class under MFDS rules. Two: choose your Korean importer before you file. Three: file each renewal at least 180 days before expiry. Classify early, then mind the clock. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.