WEF 1st July 2013, all medical devices will need to be registered within 2 years inline with the Medical Device Regulation 2012. As stipulated under Medical Device Act 2012 (Act 737), the act is to ensure all medical devices in the country are in compliance with safety and performance requirements. Medical equipment that need to be registered ranging from sophisticated clinical medical equipment to home-use medical devices and accessories, such as MRI and CT Scanner, blood pressure monitors, thermometers, nebulizers, stethoscopes, sphygmomanometers, to easily obtained bandages, condoms, etc.
The medical devices had been divided into four risk categories – low, medium, high to medium and high. Under Act 737, all medical device establishments will be given a 1 year transition period, starting 1st July 2013, to apply for licensing with the authority. The establishment licensing initiative covers manufacturers, authorized representatives of foreign manufacturers, importers and distributors.