Japan – Convergence: First-year experience with Japan’s amended medical device rules

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management process to allow for continuous improvement of medical devices.

The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided an overview and update on the changes during RAPS Convergence 2021.

Priority and conditional review
The PMD Amendment introduced new provisions to prioritize certain products, including:

  • SAKIGAKE designation system
  • Priority review for specific uses, such as pediatric use
  • Conditional Approval System
  • Post-Approval Change Management Protocol (PACMP) for Medical Devices…