India has made significant strides in the healthcare sector in the past few decades. In 2017, India's regulatory authority - the Central Drug Standard Control Organization (CDSCO) - published the Medical Device Rules, 2017, which came into force as of January 1, 2018. While the regulations brought more structure to India's developing regulatory framework, they also raised a number of questions.
In this white paper, we will discuss the key changes in the regulation and what this means for companies selling their devices in India. You will learn:
Download our white paper for answers to your biggest questions about medical device market access in one of Asia's fastest-growing markets.
近年来,全球医疗法规监管日新月异,各国、各地区监管机构纷纷出台、变更当地法规。与此同时,作为全球第一大医疗器械市场的美国,在其法规领域也做出诸多变化。这给不少以上市美国市场为目标的医疗器械企业及制造商带来了不小的挑战。 对此,Emergo by UL法规专家团队准备举办一场线上研
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