MDA (Medical Device Authority)

The Medical Device Authority (MDA) is the authority that regulates medical devices and IVDs sold in Malaysia. It operates under Malaysia’s Ministry of Health and was established in 2012. It 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.

The 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 executes most of its operations via the online system, MeDC@St. The authority classifies devices into Classes A through D by risk level and manages conformity assessment accordingly. 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.

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Website: MDA
Address: Level 6, Prima 9, Prima Avenue II,Block 3547, Persiaran APEC,63000 Cyberjaya, Selangor, MALAYSIA
Phone: +603 - 8230 0300
Email: Feedback Management System (FEMES)