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.