Regulatory Body

Medical Device Authority (MDA)

The authority regulating the medical device industry to ensure public safety under the Medical Device Act 2012.

About the MDA

The Medical Device Authority (MDA) is a statutory body under the Ministry of Health Malaysia. It controls and regulates medical devices, the industry, and their activities enforcing the Medical Device Act 2012 (Act 737).

Core Regulatory Frameworks

Establishment Licensing

Mandatory for all manufacturers, Authorized Representatives (AR), importers, and distributors.

GDPMD Certification

Good Distribution Practice for Medical Devices is a prerequisite for the establishment license.

Device Registration

All medical devices (Class A, B, C, D) must be registered via the MeDC@St 2.0+ system.

Visit Official MDA Website

Device Risk Classification

Devices are categorized based on risk to the human body. Higher risk classes usually require Conformity Assessment Body (CAB) review.

A
Class A - Low Risk Bandages, Wheelchairs
B
Class B - Low-Moderate Hypodermic Needles, Suction Catheters
C
Class C - Mod-High Ventilators, Orthopedic Implants
D
Class D - High Risk Heart Valves, Pacemakers
Our Registration Services