India Medical Device Regulations

All documents listed below were published by the Ministry of Health and Family Welfare (MHFW) and are in PDF format. The Ministry of Health and Family Welfare imposed the Medical Device Rules in January 2018; regulatory and guidance documents referring to its requirements are available here.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.

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India Medical Device Regulations

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Dutch regulators weigh in on no-deal Brexit impact for medical device companies

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Meet Emergo at FIME

Clinical data and post-market compliance under the MDR

India Medical Device Regulations

Have questions on what Emergo can do for you?