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The regulatory pressures for medical device labelling in established and emerging markets

机译:成熟和新兴市场中医疗器械标签的监管压力

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摘要

For medical device manufacturers, intensifying regulations in established territories and the diverse requirements of emerging markets mean that managing packaging and labelling content has become a costly, labour-intensive and risk-laden pursuit As medical device companies seek to enter new territories, to compensate for the absence of growth in more established markets, they are also subject to additional challenges - particularly from a regulatory perspective. Organisations must cope with changing and intensifying regulatory conditions in their existing markets and adjust to the often substantially differing requirements of markets further afield -especially in emerging economies.
机译:对于医疗器械制造商而言,成熟地区法规的加强和新兴市场的多样化要求意味着,管理包装和标签内容已成为一项昂贵,劳动密集型和高风险的追求,因为医疗器械公司寻求进入新的领域以补偿由于没有更成熟的市场增长,它们也面临着其他挑战,尤其是从监管角度而言。组织必须应对现有市场中不断变化和加剧的监管条件,并适应更远的市场(尤其是新兴经济体)市场上通常存在的实质性差异。

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