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January 21, 2019updated 23 Dec 2019 10:25am

MTaI welcomes India’s acceptance of eIFU for medical devices

The Medical Technology Association of India (MTaI) has welcomed news that the Indian Ministry of Health & Family Welfare has accepted electronic instructions for use (eIFU) for medical devices and equipment.

By Charlotte Edwards

The Medical Technology Association of India (MTaI) has welcomed news that the Indian Ministry of Health & Family Welfare has accepted electronic instructions for use (eIFU) for medical devices and equipment.

MTaI represents leading research-based medical tech companies that have significant investments in India. The association said the eIFU acceptance is in is line with the government’s push for digitisation of the medical industry so that the use of paper can be reduced.

The Ministry of Health & Family Welfare has published a Gazette notification about the acceptance of eIFU for medical devices and equipment.

MTaI chairman and director general Pavan Choudary said: “The acceptance of eIFU for medical device and Eeuipment puts India’s regulatory specifications in line with the practices of some of the advanced countries like Singapore, USA and countries of Europe and will improve users’ access to more detailed and up-to-date information.”

MTaI has also said that the inclusive approach of the Central Drugs Standard Control Organization (CDSCO) and the Health Ministry in considering suggestions is encouraging for the industry.

Choudary added: “Many products cannot be supplied with paper IFU as the product is transferred to the loaner kit in the supply chain and sterilized before being supplied to the doctor; the acceptance of eIFU will remove such issues.”

MTaI had previously made several requests to the CDSCO for the acceptance of eIFU for medical devices and equipment. The association is looking to to partner with the government so they can plan a strategy for growing the country’s medical devices sector. Current plans include bringing in bigger investments through the ‘Make in India’ initiative, as well as technology upgrades and dissemination in the provider space.

Make in India is a scheme which was launched by the Government of India in 2014 to encourage companies to manufacture products in India and increase their investments in the country.

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