The Policy and Strategic Planning Division of MDA plays a vital role in formulating and coordinating policies and strategies related to the regulation of medical devices in Malaysia. The functions of this division include:

Technology Assessment & Evaluation Unit

  • Conducts regulatory studies and technology assessments to enhance the control of medical devices.

Guidance Document Unit

  • Plans, coordinates, and publishes guidance documents to ensure understanding and compliance with regulations.

Policy & Regulatory Unit

  • Plans and coordinates policy amendments and regulatory implementation strategies under Act 737.

Strategic Planning Coordination Unit

  • Monitors the achievement of MDA’s strategic plans and coordinates planning and certification activities.

Usage & Healthcare Facility Unit

  • Develops competency programs, conducts inspections of healthcare facilities, and manages medical device permits.

Inter-Agency & Collaboration Unit

  • Manages strategic collaborations with agencies within and outside the Ministry, and coordinates partnerships with stakeholders.

 

Prepared by: Policy and Strategic Planning Division 

Uploaded by: Corporate Communication Division 

Date of upload: 12/11/2025