🇲🇾Malaysia Medical Device Regulations

Medical Device (Exemption) Order 2024

Exemption order effective March 5, 2024 covering personal use, demonstration, education, clinical research, performance evaluation, and export-only devices.

MDA Legislation Documents Collection

Collection of all medical device legislation including Act 737, Act 738, Medical Device Regulations 2012, and subsequent amendments.

Medical Device Registration Information

Comprehensive registration information including requirements for Class A-D devices, conformity assessment bodies, and registration pathways.

MDA Guidance Documents Collection

Collection of guidance documents to help industry comply with Medical Device Act 737 and regulations. Covers classification, registration, labeling, and QMS requirements.

Medical Device Classification Guidance

Malaysia uses ASEAN-aligned risk-based classification: Class A (low risk), Class B (low-moderate), Class C (moderate-high), Class D (high risk). Classification determines registration pathway.

Medical Device Authority Official Portal

Official MDA portal for device registration, establishment licensing, and regulatory submissions. Provides access to MDAR online registration system.

Medical Device Act 2012 - Full Legal Text

Primary legislation governing medical devices in Malaysia. Act 737 published in Gazette on February 9, 2012. Establishes MDA authority, device registration, establishment licensing, and enforcement.