Medical Device Application Flow
Step 1: GDPMD Certification & Establishment License (EL)
• Companies must first obtain GDPMD Certification and apply for an Establishment License (EL) via the MeDC@St system.
Step 2: Device Classification
• Identify the correct class (A–D).
Step 3: Appoint Local Authorised Representative (if overseas manufacturer)
• A Malaysian-based LAR is mandatory.
Step 4: Prepare Technical Documentation
• Device description & intended use
• Risk classification & Essential Principles checklist
• Clinical/performance evidence
• Labelling & Instructions for Use (IFU)
• Preparing CSDT Techincal File
Step 5: Conformity Assessment (CAB)
• A Conformity Assessment Body (CAB) reviews technical documentation.
• Issues a Conformity Assessment Report (CAR) based on device class.
Step 6: Submission to MDA
• Apply via MeDC@St with device information, CAR, and fees.
Step 7: MDA Review & Approval
• MDA evaluates submission.
• Upon approval, device is listed in the MDA Register of Medical Devices.
• Registration validity: 5 years (renewable).