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In Brief: Japan PMDA Issues Guidance on Package Insert Digitization Requirements

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) published a guidance document with directions for posting digital package inserts online

Japan with Mt. Fuji in the background

April 27, 2021

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a document (links in Japanese) explaining the updated requirements for package insert digitization. Starting on August 1, 2021, package inserts for all classes of medical devices and IVDs must be posted to the Medical Device Safety Information Posting System on the PMDA website, allowing them to be viewable using a mobile application that will be available for free download. Excluded from this requirement are products purchased directly by consumers, for which paper package inserts will continue to be included.

These changes are in line with a revision to the Pharmaceuticals and Medical Devices Act (PMD Act) passed in 2019. In addition to saving paper, converting package inserts to digital form is meant to enable manufacturers to update information in a rapid and uniform fashion when further clinical evidence becomes available.

Guidance features notes on how to post digital package inserts online

The document provides notes on using the system and posting package inserts; it also includes an attachment containing instructions for posting the package insert information for the first time. Links to previous PMDA notifications regarding the digitization of package inserts provide helpful background for the current requirements.

An English document that includes a summary of the digitization requirements can be found here.

Additional Japanese medical device and IVD regulatory resources:

  • Japan PMDA medical device registration and approval consulting
  • Japan PMDA registration support for IVD manufacturers
  • Japan Medical Device Nomenclature (JMDN) and medical device classification consulting

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