🩺 Medical Device Registration in Malaysia
In Malaysia, all medical devices must be registered with the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737) before they can be imported, exported, or marketed.
Who Needs to Register?
• Manufacturers – Companies producing medical devices locally.
• Importers – Businesses bringing medical devices from overseas into Malaysia.
• Distributors – Entities supplying medical devices in the Malaysian market.
All must first obtain an
Establishment License from the MDA before proceeding with device registration.
Classification of Medical Devices
Devices are classified based on risk level (aligned with GHTF/IMDRF guidelines):
• Class A – Low risk (e.g., stethoscopes, bandages)
• Class B – Low-moderate risk (e.g., suction equipment, hypodermic needles)
• Class C – Moderate-high risk (e.g., ventilators, infusion pumps)
• Class D – High risk (e.g., pacemakers, implantable devices)
Registration Process
1. Apply for Establishment License (EL):
• Obtain GDPMD Certification (Good Distribution Practice for Medical Devices).
• Apply online via the MeDC@St system (MDA portal).
2. Appoint a Local Authorised Representative (LAR):
• Required if the manufacturer is based overseas.
3. Prepare Technical Documentation:
• Device description, intended use, risk classification.
• Clinical evidence, performance data, safety reports.
• Labelling, instructions for use, packaging details.
4. Submit Application via MeDC@St:
• Fill in product details, upload documents, and pay registration fees.
5. Conformity Assessment Body (CAB) Review:
• CAB reviews technical documentation and issues a Conformity Assessment Report (CAR).
6. MDA Approval & Device Registration:
• Upon approval, the device will be listed in the MDA Register of Medical Devices.
• Registration is valid for 5 years, subject to renewal.