Business Standard

Medical (MTaI), which represents leading companies with significant investments in India, today welcomed the Ministry of & notification on acceptance of eIFU (Electronic Instructions for Use) for and Equipment and said that the regulation is in line with governments push for digitalization to reduce the use of Paper.

Ministry of & Family Welfare on January 15, 2019, published the Gazette notification on acceptance of eIFU for and Equipment. “The acceptance of eIFU for and Equipment puts India’s regulatory specifications in line with the practices of some of the advanced countries like Singapore, USA and countries of and will improve users access to more detailed up-to-date information,” said Mr. Pavan Choudary, Chairman and Director General, MTaI.

MTaI further said that the inclusive approach of and 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 and sterilized before being supplied to the doctor, the acceptance of eIFU will remove such issues.” Mr. added.

MTaI had made several representations to the for the acceptance of eIFU for Medical Device and Equipment.

Medical (MTaI – pronounced as Em-tai) is a not-for-profit organization duly registered under sub-section (2) of section 7 of the Companies Act, 2013 and Rule 8 of the Companies (Incorporation) Rules, 2014.

MTaI is an association of companies which have made remarkable investments in Manufacturing, R&D and Health Care Workers Training in MTaI represents a wide spectrum of the medical device industry with global experience in innovation and MTaI wants to be a responsible voice of the industry stressing on the three hallmarks of – Quality, Consistency and Patient Safety. The association is committed to improving access to affordable and quality for patients.

MTaI looks to with the in setting a roadmap for the growth of medical devices sector by bringing in even bigger investments in this sector, through ‘Make in India’ and through and dissemination in the provider space.