Malaysia MDA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: Medical Device Authority (MDA), under the Ministry of Health Malaysia
Key Legislation:
- Medical Device Act 2012 (Act 737)
- Medical Device Regulations 2012
- Medical Device (Conformity Assessment) Regulations 2022
- ASEAN Medical Device Directive (AMDD) signatory
Classification: Risk-based, 4 classes (aligned with ASEAN AMDD):
- Class A (low risk) | Class B (low-medium risk) | Class C (medium-high risk) | Class D (high risk)
Registration Pathway:
- Establishment registration with MDA
- Device registration via MeDC@St (Medical Device Conformity Assessment System)
- Class A: registration notification
- Class B/C/D: conformity assessment with Conformity Assessment Body (CAB)
- Manufacturing site audit for higher-risk devices
Key Requirements:
- Device registration mandatory before marketing (all classes)
- Establishment License required for manufacturers, importers, distributors
- CSDT (Common Submission Dossier Template) format documentation
- Malay and/or English labeling
- ISO 13485 for manufacturing quality management
- Post-market surveillance and adverse event reporting
- Registration validity: 5 years
Current Key Guidance:
Latest Updates
No recent updates available. Please check back later.