MDA (Medical Device Authority)

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.

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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)