MDA was formed as a statutory body under the Ministry of Health Malaysia that is responsible for the implementation and enforcement of Medical Device Act 2012 (Act 737) following the gazettement of the Medical Device Authority Act (Act 738). Implementation of regulatory control under the medical device law is of great benefit to the Malaysian public, as all medical devices that to be placed in our market must demonstrate compliance with safety and performance requirements as stipulated under the Act 737. The regulatory framework provides appropriate control for ensuring public health and safety by ensuring access to safe and effective medical devices while preventing substandard, unsafe, and ineffective devices from reaching the market.
MDA is providing opportunities for Sabah medical device industry players to participate in face-to-face engagement session that serves as a strategic platform to:
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