베트남 IMDA: 의료기기 등급 및 등록

What is Vietnam's IMDA? It is the Ministry of Health's medical device regulator, known in English as VIMDA. Since November 2025, it grants Class C and D registrations itself. Vietnam sorts medical devices and IVDs into four risk classes, A to D. Classes A and B are declared to a provincial Department of Health. Classes C and D need a registration number from IMDA, applied for through the Health Ministry's online portal. And once granted, that number does not expire. Under Decree 98, every Vietnamese circulation number, Class A to D, is valid indefinitely, unless it was issued as an emergency number. And government fees are halved for now. Through December 31, 2026, the review fee for a Class C or D registration is three million dong, not six million. Start with three things. One: confirm the class, A to D. Two: name a Vietnamese company or representative office as holder. Three: file C and D dossiers through the online portal. Right class, right office, right time. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.