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Registration, Licensing & Enforcement Division

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FUNCTIONS OF REGISTRATION, LICENSING AND ENFORCEMENT DIVISION

  • Develop, plan, coordinate and implement activities of assessment, review and approval of application for; 

i - registration of medical devices 

ii - registration of Conformity Assessment Body (CAB)

iii - licensing of establishment

  • Coordinate and implement technical advisory activities on registration of medical devices, registration of Conformity Assessment Body (CAB) and licensing of establishment;
  • Develop, plan, coordinate and implement surveillance and vigilance activities pertaining to safety and performance of the medical devices and establishments’ obligations in the post-market phase through:-   

i -   complaints on safety and performance of medical devices

ii -  mandatory problem reportingiii - field corrective actions

iv - recall

  • Develop, plan, coordinate and implement enforcement activities including;-

i - Inspection,

ii - Intelligence and investigation,

iii - Search and seizure

iv - Prosecution

The Registration, Licensing, and Enforcement Division is divided into 2 branches namely:- 

i - Registration & Licensing Branch consisting of 3 units namely the Medical Devices Registration Unit, Compliance Assessment Agency Registration Unit and Establisment Licensing Unit,

ii - Surveillance and Enforcement Branch comprising 2 units namely the Post Market Surveillance & Vigilance Unit and Enforcement Unit

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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