OEMs make medical devices to be sold by other companies. The characteristics of such companies put them outside the definition of a medical device business established in Malaysian legislation on the sector. As such, OEMs have been unable to provide the establishment and medical device registration they need to apply for a certificate of free sale to sell their products globally. MDA has created a two-pronged strategy to address the gap in the medical device rules. Now, local manufacturers that work as OEMs can become licensed as manufacturers and register their devices under their own brands. The company then declares the “listed brand is the same as the registered medical device brand in terms of manufacturing processes, specifications and etc.” The second pathway applies to OEM for non-owned brands. In this situation, MDA is proposing to license the companies through the authorized representative system, a mechanism that allows firms without a presence in Malaysia to operate in the market. The product registration uses a brand or medical device name and is exempt from certain requirements. MDA brought the changes in with immediate effect. More Information On RAPS