Medical Device Authority (MDA)

What is Malaysia’s MDA? 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). It implements and enforces the Medical Device Act 2012 (Act 737), overseeing the control and regulation of medical devices across the country. What does the MDA do? 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 licences to local manufacturers, authorised representatives, importers, and distributors, and registering Conformity Assessment Bodies (CABs) responsible for evaluating product documentation and quality systems. The authority classifies devices into Classes A through D by risk level and manages conformity assessment accordingly, with lower-risk devices exempt from CAB review and higher-risk devices requiring full conformity certification. Additionally, MDA oversees pre-market authorization of devices, regulates advertising, monitors post-market vigilance, and enforces compliance—including import/export permits, recall actions, and product labelling under Malaysia’s single‑licence policy.