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Medical devices are regulated by the Medical Device Authority under the Ministry of Health.
Devices are classified according to risk into Classes A, B, C, and D.
As device registration was not mandatory in Malaysia until July 2014, it is not yet clear how long the approval process may take, but it is currently estimated to take about one year.
Licenses are valid for five years.
An authorized representative is required to register medical devices in Malaysia.
Last updated on January 29 2015.
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For more information on registration in Malaysia, check out the following articles on our blog:
Country at a Glance: Malaysia
5 Questions and Answers: Malaysia