Objectives

Our Objectives:

  • To regulate, control, and monitor of all matters related to medical devices, stakeholders and Conformity Assessment Bodies.
  • To be responsible for assessment and approval of application for medical devices registration, licensing of medical device establishment and CABs.
  • To identify and determine the standards for compliance with conformity assessment procedures of medical devices
  • To control, supervise and monitor contents and materials used in advertisement of medical devices.
  • To control, supervise and monitor distribution records of medical devices.
  • To supervise and monitor post-market surveillance and vigilance system.
  • To control, monitor and investigate complaints and mandatory adverse event reporting of medical devices.
  • To control, supervise and monitor field corrective action of medical devices.
  • To control, supervise and monitor recalls of medical devices.
  • To control, supervise and monitor calibration, maintenance, operation, decommissioning and disposal of medical devices.
  • Control of usage and operation of designated medical devices.
  • To communicate authoritative and reliable information and advice to improve public and professional awareness.
  • To encourage technical innovation and technology transfer for the advancement of medical devices technology.
  • To encourage and facilitate trade liberalization of medical devices with other countries.
  • To promote cooperation and establish Mutual Recognition Agreement amongst countries on medical devices regulation.
  • To monitor and impose fee for medical devices registration, licensing of establishment involved with marketing of medical devices and operational and usage permits for designated devices.

 

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