Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in India, welcomed the Ministry of Health & 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.
Ministry of Health & Family Welfare on January 15 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 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 sterilised before being supplied to the doctor, the acceptance of eIFU will remove such issues,” Choudary added.
MTaI had made several representations to the CDSCO for the acceptance of eIFU for medical device and equipment.
