Acceptance of eIFU for medical device a welcome move: MTaI

As per the Association representing global medical technology companies, the notification on acceptance of 'electronic instructions for use' from health ministry is in line with regulatory practices of several advanced countries

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New Delhi: Medical Technology Association of India (MTaI) has welcomed the Ministry of Health and Family Welfare Gazette notification on acceptance of eIFU (electronic instructions for use) for Medical Device and Equipment and said that the regulation is line with governments push for digitalization to reduce the use of Paper.

Health Ministry on January 15, 2019 published Gazette notification on acceptance of eIFU for Medical Device and Equipment. “The acceptance of eIFU for Medical Device and Equipment 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,” said Mr Pavan Choudary, Chairman and Director General, MTaI.

MTaI further said that the inclusive approach of CDSCO and Health Ministry in considering suggestions encourages the industry. “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.” Mr Pavan Choudary added. MTaI had made several representations to the CDSCO for the acceptance of eIFU for Medical Device and Equipment.