Harmonized Medical Device Regulation: Need Challenges and Risks of not Harmonizing the Regulation in Asia

摘要

Medical device sector is one of the most complex and challenging business segments of the healthcare industry with close collaboration between science and engineering. Despite the fact that Asia has 60% of the world population providing large market potential, Asian healthcare expenditure constitutes only 15% of the global healthcare expenditure. The accelerated ageing population and increasing prevalence of chronic disease are the key drivers that contribute toward the increase in the total healthcare expenditure on medical devices in the region. Several policies clearly showed the eagerness of the government to provide better healthcare infrastructure with better medical devices and facilities. The fundamental objective of the regulatory harmonization is to improve the efficiency of national economies and their ability to adopt to change and remain competitive. After the era of liberalization and globalization, the desires of developing economies is to ensure safety and performance of the product brought to their markets and for this harmonized regulation is an important tool for strengthening the same. If we talk about the industry need, then this approach will eliminate redundant requirements that do not contribute to safety and effectiveness. In addition, Asia is diverse in many respects and with it come the various challenges to harmonizing the regulation which includes diversity in culture, politics, economy, historical issues, etc. If, by any reason, the regulation of medical devices is not harmonized and consequently, the harmonized regulation is not adopted, then it leads to serious concerns like delayed or absent access to innovative technology, continued rise in the cost of medical therapies, etc. So this issue is written to attract all stakeholders to move toward the concept of harmonization, keeping in mind their need, challenges, and risks of not harmonizing the regulation as well.