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The Technical Evaluation Division


  • Plan, develop and coordinate regulatory activities for medical devices that are exempt from registration requirements under Act 737;
  • Plan, develop and coordinate evaluation activities of notification applications for exemption of medical device from registration requirements;
  • Plan, develop, coordinate and manage research to provide relevant evidence/facts to support policy/policy setting for regulatory control of medical devices;
  • Plan and develop the Register system for access to medical device information under Section 67 of Act 737;
  • Plan and develop a medical device regulatory resource center;
  • Plan and coordinate the establishment and function of technical and scientific committees related to medical devices that are exempt from registration requirements
  • Carry out activities/technical advisory services on the safety and efficacy issues of medical devices;
  • Carry out ICT strategic planning and management activities as follows:- 

i - Manage and coordinate ICT project development based on PBPP ICT Strategic Plan;

ii- Plan and manage infrastructure requirements (hardware, software, networking, application systems), ICT services and security;

iii- Plan and manage ICT training and development programs according to the needs of the organization; and

iv- Managing and providing ICT expertise in accordance with the needs of parts or units.


  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200