Many countries in Asia have growing per-capita incomes, a rapidly expanding middle class, and increasing elderly populations. Growing incomes in 2015 will lead to more healthcare spending, benefiting companies that are established in Asian medical device markets. Asian gross domestic product (GDP) is expected to grow more than 6% in 2015.
In 2014, the Asian medical device market was worth approximately $65 billion and is experiencing double-digit growth. Asia represents almost 20% of the global device market.
The ten countries that make up the Association of Southeast Asian Nations (ASEAN) recently finalized the ASEAN Medical Device Directive (AMDD), which should go into effect in January, 2015. The AMDD provides a harmonized regulatory model for countries across ASEAN, including a harmonized risk-based classification system and submission dossier template. ASEAN countries currently import the majority of their medical devices — often from Western medical companies. Harmonized regulations and submission documentation will make it much easier to register and import devices in Southeast Asia, at least in theory.