Many Asian countries now have rising per capita incomes, rapidly expanding middle classes, and growing elderly populations. Income growth in 2015 will lead to increased medical spending, benefiting companies already active in Asia’s medical device market. Asia’s gross domestic product (GDP) is projected to grow by more than 6% in 2015.
In 2014, Asia’s medical device market was valued at around USD 65 billion and was experiencing double-digit growth. Asia accounted for nearly 20% of the global medical equipment market share.
The Association of Southeast Asian Nations (ASEAN) recently completed the ASEAN Medical Device Directive (AMDD), which came into effect in January 2015. The AMDD provides a unified regulatory framework for all ASEAN countries, including a standardized risk-based device classification system and submission templates. Currently, most medical devices in ASEAN countries are imported—often from Western medical device companies. The harmonized regulations and documentation requirements will, at least in theory, make product registration and imports of medical devices into Southeast Asia easier.