Kaushik A, Saini Ks, Anil B, Rambabu S
Department of Pharmaceutical Sciences, Jodhpur National University, Jodhpur, Rajasthan, India.
J Young Pharm. 2010 Jan;2(1):101-6. doi: 10.4103/0975-1483.62221.
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.
医疗设备行业是医疗保健行业中最复杂、最具挑战性的业务领域之一，需要科学与工程领域密切合作。尽管亚洲拥有全球60%的人口，具有巨大的市场潜力，但亚洲的医疗保健支出仅占全球医疗保健支出的15%。人口加速老龄化和慢性病患病率上升是该地区医疗设备总支出增加的关键驱动因素。多项政策明确显示出政府渴望提供配备更好医疗设备和设施的优质医疗基础设施。监管协调的根本目标是提高国民经济的效率及其适应变化和保持竞争力的能力。在自由化和全球化时代之后，发展中经济体希望确保进入其市场的产品的安全性和性能，而协调监管是加强这方面的重要工具。如果谈及行业需求，那么这种方法将消除那些对安全性和有效性没有贡献的冗余要求。此外，亚洲在许多方面存在差异，这给监管协调带来了各种挑战，包括文化、政治、经济、历史问题等方面的差异。如果由于任何原因，医疗设备监管未能实现协调，进而未能采用统一的监管标准，那么就会引发严重问题，如创新技术的获取延迟或无法获取、医疗治疗成本持续上升等。因此，撰写本文旨在吸引所有利益相关者朝着协调统一的理念迈进，同时牢记他们的需求、挑战以及不进行监管协调所带来的风险。
