Licensing - Speakers
ESTABLISHMENT LICENSING UNIT
The Establishment Licensing Unit within the Pre-Market Control Division, Medical Device Authority (MDA) responsible for overseeing the licensing of establishments involved in the importation, distribution, and placement of medical devices in the Malaysian market. This includes manufacturers, authorized representatives, importers, and distributors.
The unit ensures that all establishments comply with the requirements set out under the Medical Device Act 2012 (Act 737) and its subsidiary regulations. Its core functions include processing license applications and evaluating supporting documentation. By facilitating a structured licensing process, the unit supports MDA’s mission to safeguard public health through the regulation of medical devices in Malaysia.
