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

Download the white paper: 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 made significant updates to registration requirements and the approval process for foreign medical device manufacturers. In this white paper, we discuss how to register a medical device for sale in Japan as a foreign company and requirements to be aware of, including:

 

  • 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

You'll learn all this and much more in this 8-page white paper.