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Medical Device Authority (Medical Device Act 737 (2012) :fountain_pen:…
Medical Device Authority
Objectives :star:
To identify and determine the standards for compliance with conformity assessment procedures of medical devices.
To be responsible for assessment and approval of application for medical devices registration, licensing of medical device establishment and CABs
To control, supervise and monitor contents and materials used in advertisement of medical devices.
To regulate, control, and monitor of all matters related to medical devices, stakeholders and Conformity Assessment Bodies.
To control, supervise and monitor distribution records of medical devices.
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Mission :check:
To provide regulatory control of medical device industry in Malaysia, through compliance of act by ensuring safety and performance to protect public towards excellence customer satisfaction.
Core Values :smiley:
Integrity, Effective, Professional
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