Technologically advanced solutions for treatment of diseases, scientific rigor and research has seen tremendous growth in therapeutic usage of medical devices. The role of ‘Make in India’ initiative becomes of utmost importance as a driving force for technological advancement of medical devices industry. However, challenges exists and need to be addressed in providing affordable healthcare by producing medical devices that are cost competitive and effective to increased access. Asian Countries like Japan, China and South Korea are foremost in the Medical devices sector. This paper probes the sustainability of Make in India policy with the growth trajectory of Asian countries in medical devices discusses ways of overcoming challenges through regulations, policies and other stakeholders contribution.