Medical devices are regulated by the Medical Device Authority under the Ministry of Health. CLASSIFICATION SYSTEM:
Devices are classified according to risk into Classes A, B, C, and D. TIMEFRAME:
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. LICENSE VALIDITY:
Licenses are valid for five years. AUTHORIZED REPRESENTATIVE:
An authorized representative is required to register medical devices in Malaysia.
Last updated on January 29 2015.
ARE YOU INTERESTED IN REGISTRATION IN MALAYSIA? REQUEST A FREE QUOTE>
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