Creation of Medical Device Authority A separate regulatory move, The Medical Device Authority Act,

Creation of Medical Device Authority
A separate regulatory move, The Medical Device Authority Act, also was passed by Malaysia’s Ministry of Health in February. The act creates a regulatory body called the Medical Device Authority that will oversee the new mandatory registration of medical devices and related establishments. Previously, the Medical Devices Bureau—a division within the Ministry of Health—was responsible for overseeing the voluntary regulation and development of Malaysia’s medical device industry.

The newly formed authority will be charged with the responsibility to enforce the new regulations on medical devices stipulated in the Medical Device Act 2012. This regulatory body also will be solely responsible for promoting the further development of the medical device industry in Malaysia.

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These two acts—the Medical Device Act of 2012 and the Medical Device Authority Act—will have far-reaching effects on the Malaysian medical device market. The mandatory registration of medical devices, as well as a new regulatory body, will serve to improve the quality and compliance of medical devices. Additionally, the acts will grant legal protection for medical devices under patent law, thus encouraging foreign investment in Malaysia’s growing medical device market.