말레이시아 MDA: 의료기기 규제

What is Malaysia's MDA? It is the Medical Device Authority. It registers devices and licenses the companies that supply them. And since January 2026, Class A registration costs more. Since January 1, 2026, a Class A application costs 500 ringgit, and a new 750 ringgit registration fee applies, for new and re-registrations alike. Until then, it was 100 ringgit to apply, and no registration fee. Use Malaysian class names, too. Every device falls into one of four risk classes, A, B, C or D, and the manufacturer is responsible for classifying it under Malaysia's own rules. There is no Class II here. Registration is only half of it. The device stays registered for five years. Every company that imports or distributes it also needs its own establishment licence, valid for three years. Start with three things. One: classify under Malaysian rules, A to D. Two: appoint a licensed authorised representative in Malaysia. Three: file re-registration as soon as it opens, a year before expiry. Register the device, license the company. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.