In the past, Malaysia has not had any medical device regulations, including product registration. In March 2012, Malaysia’s Ministry of Health (MOH) cleared legislation for two acts that will establish a new regulatory agency for medical devices and require mandatory registration of medical devices.
The Medical Device Act 2012 (Act 737) will be phased in over the next two years and effectively replace Malaysia’s current voluntary registration scheme (MeDVER). It requires all imported and locally manufactured medical devices to be registered with the Medical Device Control Division (MDCD) – the bureau within Malaysia’s MOH that is charged with regulating the country’s medical device industry. Medical devices—defined as any instrument used for the use of diagnosis, prevention, monitoring, and/or treatment of disease and injury—will be categorized into Classes A through D depending on the risks level of the product and its intended use.
The Medical Device Act 2012 also requires all medical device establishments to register and obtain licenses from the MOH. This includes manufacturers, importers, distributors, and conformity assessment bodies.
The Medical Device Authority Act 2012 (Act 738) establishes a new regulatory body charged with enforcing the regulations stipulated by the aforementioned Medical Device Act 2012. The newly established Medical Device Authority is also responsible for promoting the further development of Malaysia’s medical device industry, currently valued at about $900 million.
Malaysia’s medical device market will be significantly impacted by the enforcement of these two legislations. In particular, the Medical Device Act will ensure improved quality and compliance of medical devices. It will also legally protect the medical devices under the country’s patent law. This will hopefully encourage foreign medical device companies to invest in Malaysia’s growing medical market.