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.

 

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Kemaskini Terakhir: 08 Oktober 2020.
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Ministry of Health Malaysia
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