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Although similar in many aspects of manufacturing and regulatory provisions to medicines, medical devices have their provisions and attract considerable investments in manufacturing and innovation. While the U.S. holds the leading global position in the devices market, Asia Pacific (APAC) countries like China, Japan, Singapore, and South Korea have proved tremendous market potential holding top ten positions. Still, many APAC countries are import-reliant due to hurdles in technological innovation and regulatory provisions. The review aimed to explore those predictors or hurdles and analyzed these to enhance the region’s export capacity gradually. 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.

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