Overview of Regulatory Medical Device
Medical Device Authority (MDA) is a statutory body under the Ministry of Health Malaysia which was established under the Medical Device Authority Act 2012 (Act 738) to control, regulate medical device, its industry and activities as well as to enforce medical device law under Medical Device Act 2012 (Act 737).
Our regulatory role is mainly to:
1. Facilitate trade and industry
2. Ensure public health and safety
Thus, MDA’s core competent includes:
• Licensed of Establishment
‐ Manufacturer
‐ Authorised representative
‐ Importer
‐ Distributor
• Registration of Conformity Assessment Body (CAB)
‐ Quality Systems Certification
‐ Products Testing
• Registration of Medical Device
‐ Class A
‐ Class B
‐ Class C
‐ Class D
• Notification for medical devices for:
‐ The purpose of demonstration for marketing
‐ The purpose of education
‐ The purpose of clinical research or performance evaluation of medical device
‐ A Custom-Made Medical Device
‐ A Special Access Medical Device
• Lists of licensed establishments
• Lists of registered products
• Usage
‐ Registration of Competent personnel
› Maintenance
› Disposal
‐ Permit of Designated Device
• Export permit
• Advertisement of Medical Device
• Adoption of harmonised regulation
• Adoption of International Standards
• Post-market Surveillance and Vigilance
• Enforcement
