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The Technical Evaluation Division

FUNCTIONS OF 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.

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  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 
  mdb@mda.gov.my