Gap analysis in manufacturing, innovation and marketing of medical devices in the Asia-Pacific region.

Policymakers in APAC countries with no device manufacturing and health technology assessment capacities would be benefited from the review. The findings showed the presence of a gap in manufacturing, innovation, and marketing of devices within the APAC region and between APAC and western countries. Stringent regulatory measures and quality indicators are still lacking in many APAC nations, and there is an urgent need to harmonize regulatory standards. Being a region constituting over one-third of the global population, a considerable investment in innovation, manufacturing, and establishing quality standards is urgently needed among APAC countries to ensure an adequate supply of quality medical devices.