印度对医疗器械进口的要求-浙江药品认证检查中心.docVIP

印度对进口医疗器械的要求 认证中心 夏芸 摘要：本文介绍了国外医疗器械产品进入印度市场的法规要求。主要阐述了部分医疗器械在印度的监管情况和监管部门，并详细介绍了印度政府于2006年3月实施的《医疗器械的进口和生产指南》的内容。为我国医疗器械企业的产品进入印度市场提供参考。 Abstrat：This article introduces the medical device regulations in India, highlights the medical device regulatory climate in India and the regulate department, in detail introduces the content of the guideline Guidelines for import and manufacture of medical devices issued by India government in 1st March 2006. This article will be a reference for the companies which are looking to India as a market for their finished devices. 关键词：印度(India)；医疗器械（medical de