MDA (Medical Device Authority)
The Medical Device Authority (MDA) is the authority that regulates medical devices and IVDs sold in Malaysia. It is a statutory body operating under Malaysia’s Ministry of Health, established under the Medical Device Authority Act 2012 (Act 738).
Video guide
Malaysia MDA: Medical Device Regulation
An overview of Malaysia's Medical Device Authority, device registration, local representation and Class A fees.
Open video pageTranscript (English)
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.
The Medical Device Authority (MDA) is the authority that regulates medical devices and IVDs sold in Malaysia under the Ministry of Health. MDA ensures that medical devices on the Malaysian market meet required safety and quality standards from pre-market through post-market phases. Its activities include granting establishment licenses to local manufacturers, authorized representatives, importers, and distributors, and registering Conformity Assessment Bodies (CABs) responsible for evaluating product documentation and quality systems. MDA oversees pre-market authorization of devices, regulates advertising, monitors post-market vigilance, and enforces compliance, including import/export permits, recall actions, and product labeling. MDA executes most of its operations via the online system, MeDC@St.
When was the MDA established?
MDA was established in 2012 under the Medical Device Authority Act (Act 738).
What key medical device regulations does MDA enforce?
MDA enforces key medical device regulations such as Medical Device Act 2012 (Act 737), Medical Device Authority Act 2012 (Act 738), and Medical Device Regulations 2012, and oversees the control and regulation of medical devices across the country.
Does MDA charge fees for medical device regulatory activities?
Yes, MDA charges applications and registration fees for devices and establishment application and licensing fees for all parties requiring establishment licenses. Device application and registration fees apply across all classes (application and registration fees for Class I devices went into effect in January 2026) and increase with device risk.
How can I contact the Malaysia MDA?
Malaysia MDA can be contacted via their Feedback Management System (FEMES) or via their website (chatbot is available for basic inquiries). They can also be contacted by phone +603 - 8230 0300 .
Website: MDA
Address: Level 6, Prima 9, Prima Avenue II,Block 3547, Persiaran APEC,63000 Cyberjaya, Selangor, MALAYSIA
Phone: +603 - 8230 0300
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