Emergo Podcast: Japan’s Medical Device Registration Process
For those wanting to learn more about medical device registration in Japan, one of the world’s largest medical device markets, this podcast from Emergo provides an overview of that country’s approval process.
Michiharu Miyahara, President and CEO of Emergo Japan, discusses frequently asked Japanese market authorization issues including:
- Various registration pathways with Japan’s Pharmaceutical and Medical Devices Agency (PMDA)
- Japan’s medical device classification system and processes
- The role of Registered Certification Bodies (RCB)
- PMDA clinical data requirements
- Device review and approval timeframes
Additional resources for Japanese medical device registration are also available from Emergo, including a whitepaper on the new Pharmaceutical and Medical Device Act (PMD Act), a PMDA regulatory process chart, and a video overview of the Japanese approval process.