Home About Qualtech NEWS INDIA: Indian MoH Now Accepts Electronic Instructions for Use (e-IFU) for Medical Devices - February 2019
INDIA: Indian MoH Now Accepts Electronic Instructions for Use (e-IFU) for Medical Devices - February 2019

February 18, 2019

Ministry of Health & Family Welfare, on January 15, 2019, has issued a new gazette notification on acceptance of e-IFU (Electronic Instructions for Use) for Medical Device. This regulation is in line with governments push for digitalization to reduce the use of Paper and puts India’s regulatory specifications in line with the practices of some of the advanced countries like Singapore, USA and countries of Europe. It is targeted to improve users’ access to more detailed up-to-date information.

Many products cannot be supplied with a Paper IFU as the product is transferred to the loaner kit in the supply chain and sterilized before being supplied to the doctor, thus the acceptance of e-IFU will remove such issues and calls for a more harmonised approach on the Asian market. Furthermore, with more aspects of the medical device market getting digital, end-users would find it more convenient and informative to be able to access the e-IFUs at the point of fingertips, having to no longer rely on printed materials over the medical device’s useful years.

 

Reference:

Rule 3 Rule 59, 4th and 7th Schedules of MDR 2017 for insertion of e-IFU

 

 

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Home About Qualtech NEWS INDIA: Indian MoH Now Accepts Electronic Instructions for Use (e-IFU) for Medical Devices - February 2019