Japanese Regulatory Approval Process Chart
ORCA Admin | Published on 12/1/2023
Japanese regulatory approval process chart
Before selling medical and in vitro diagnostic (IVD) devices in Japan, manufacturers must first register their products. The Ministry of Health, Labour and Welfare (MHLW) oversees registration, the Pharmaceuticals and Medical Devices Agency (PMDA), and third-party Registered Certification Bodies (RCBs).
To better understand the registration process, view Emergo by UL’s informative process chart, available for download in Regulatory Affairs Management Suite (RAMS)
.