Our Core Business

To protect the public health and safety, the MDB strives to ensure that medical devices in Malaysia are of high quality, effective and safe.  In doing this, we play an important role and contribute to the quality of the healthcare system in the country.  Scrutinising and thoroughly assessing medical devices involves identifying new risks and rapidly taking safety measures.  We inform medical professionals and the consumers, the patients, about specific issues and new discoveries in the medical device sector.  It is therefore a prerequisite of our work to constantly adapt our know-how and processes to the current state of scientific knowledge and technology so that we can assess new types of products, procedures and applications.

Our core competent includes :
       -  registering medical devices (all classes)
       -  issuing licences to manufacturer, distributor, importer, exporter, 
       -  inspecting facilities (establishments)
       -  monitoring medical devices already on the market
       -  monitoring operation and usage of medical devices, including disposal
       -  (laboratory testing)
       -  drafting laws and standards