Notification for the IFU for IVD
e-IFU is legislated from August 1st, 2021 in Japan. LBS Japan will insert the IFU in the IVD package until July 30th, 2021 under this circumstances. We won’t insert the hard copy of IFU in the package after August 1st, 2021. Please use e-IFU application provided by MHLW on the barcode of the Japanese label, and you can see the e-IFU at PMDA site. Thank you very much for your cooperation.
For Medical Device, we will insert the hard copy of IFU for a while, and meantime, also it’s possible to get the e-IFU by using the barcode of the Japanese label as well.