One of the most common challenges medical device companies face is prioritizing which markets to enter and where to focus their limited resources. While the largest markets, like the US, EU, China and Japan offer huge upside, manufacturers still need do their due diligence to ensure they’ll be able to compete with the bigger, more established players in these markets. On the other hand, ASEAN countries offer manufacturers rapidly developing markets with limited established brands, high reliance on imported devices and rapid growth in per capita healthcare spending. According to BMI Research, the medical device market in ASEAN countries will be the 2nd fastest growing market in the world after China, largely driven by a burgeoning elderly population and a large youth population that prioritizes their health more than previous generations.
ASEAN competent authorities have also been taking steps to make it easier for manufacturers to obtain approval by implementing the ASEAN Medical Device Directive which harmonizes numerous regulations, including the Common Submission Dossier Template (CSDT).
Let Asia Actual’s experienced professionals guide you through the various regulatory hurdles while simultaneously working with your sales teams to build effective, localized commercialization strategies to penetrate these high potential markets and build a brand that will provide returns for decades to come.