Medical Device Registration (MDA) | ARCI Regulatory Consultancy

Service Overview

Under the Medical Device Act 2012 (Act 737), all medical devices must be registered with the Medical Device Authority (MDA) before importation or sale. The process involves determining the correct risk classification and engaging a Conformity Assessment Body (CAB) for validation.

ARCI provides full-spectrum support, including Authorized Representative services, CSDT dossier compilation, and GDPMD (Good Distribution Practice for Medical Devices) consultancy.

Who This Is For

Medical device manufacturers (Local & Foreign).
Authorized Representatives (AR).
Importers and distributors of medical equipment.

Registration Pathway

1. Risk Classification

Classifying devices into Class A (Low), B, C, or D (High Risk) to determine the conformity assessment route.

2. CAB Assessment

Liaising with registered Conformity Assessment Bodies (CAB) for technical file audits.

3. MeDC@St Submission

Final submission via the Web-based Online Application System (MeDC@St) for MDA approval.

4. Post-Market Surveillance (PMS) Support

Advisory and operational support to Establishment License Holders in meeting post-market obligations, including:

Complaint Management System
Mandatory Problem Reporting
Field Safety Corrective Action (FSCA)

Medical Device FAQs

What is GDPMD? ▼

GDPMD (Good Distribution Practice for Medical Devices) is a mandatory certification for all parties involved in the supply chain (importers, distributors, authorized representatives) to ensure quality maintenance.

How long does the registration take? ▼

Timelines depend on risk class. Class A (Notification) can be fast, whereas Class B, C, and D require CAB audit and MDA review, often taking 6-12 months.

Do I need a local authorized representative? ▼

Yes. If the manufacturer is outside Malaysia, they must appoint a Local Authorized Representative (LAR) to hold the license and handle regulatory matters.