Registering Standalone Software under Japan’s PMD Act

Before the implementation of Japan’s Pharmaceutical and Medical Device Act (PMD Act) in November 2014, software and hardware were regulated as one single unit, and there was no path to registering software independent of a device. Although the PMD Act has been in effect for over a year, information about how it affects software registration and regulation is only now becoming clear.

Under the PMD Act, Software as a Medical Device (SaMD) is a standalone software that, when installed on computers or mobile devices, can be used for the diagnosis, treatment, or prevention of diseases. Examples of this type of software include programs that provide a graph, image, or index for diagnosis/treatment or programs that are used to support proposed treatment plans and methods.

There are a number of types of software that are still not regulated under the PMD Act. These are software programs that:

  • are used to process data as opposed to provide diagnosis
  • are used for computer system maintenance
  • organize in-hospital responsibilities
  • have very low-risk
  • are used for education or to assist in a doctor’s explanation
  • transfer, maintain, or display data in the form of a medical record
  • are used for in-home healthcare for daily health management or for sharing personal health history information