Japan's Pharmaceutical and Medical Devices Act (PMD Act)

In November 2014, Japan’s Pharmaceutical Affairs Law (PAL) covering medical device registration requirements was replaced by the Pharmaceutical and Medical Device Act, or PMD Act. The PMD Act contains several significant updates to the Japanese registration and approval process of which foreign manufacturers doing business in Japan should be especially aware. In this whitepaper, Emergo will identify key elements of the PMD Act that will impact foreign companies that either currently sell their devices in Japan or are considering doing so.

This whitepaper will address the following nine components of the PMD Act that will present new or significantly different registration and compliance rules for companies:

  • Strict new package insert requirements
  • Change to MAH Licensing rules
  • A new MAH License category for In Vitro Diagnostic (IVD) devices
  • A new registration system for manufacturers
  • A new QMS conformity assessment system
  • New formats for pre-market certification and pre-market approval applications
  • Expanded scope of third party certifications
  • Rules for software as a medical device
  • Rules for transferring pre-market certifications