Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has announced that package inserts for all classes of medical devices and IVDs are now required to be digitized on the PMDA’s website by the end of July 2021. From August 2021, users of medical devices will be able to access and download digital package inserts by scanning barcodes on packages using tablets and smartphones, which signifies that manufacturers are able to update their products’ package inserts with the latest information whenever scientific evidence related to safety and instructions are newly found. The users of medical devices are not only able to access the latest package inserts but also product assessment reports by PMDA when medical devices are approved.

          For manufacturers to update package inserts and allow users to access the most updated package inserts, Marketing Authorization Holders in Japan are required to make sure the followings are completed:

  1. 1. Create an account on PMDA’s “IKW Site.”
  2. 2. Upload all the package inserts of every product to the website.
  3. 3. Link each “Package Insert Number” and GTIN, and upload to the website.

By the 31th of July, Marketing Authorization Holders are required to complete at least the above procedures 1 and 2. Medical devices for daily use are excluded from this requirement of digitization and paper package inserts will be inserted as they are.




Safety Information No.381 Year 2021 to all the marketing authorization holders