Japan

Ministry of Health: 

Ministry of Health, Labour and Welfare of Japan (MHLW)

Regulatory Authority:       

Pharmaceuticals and Devices Agency (PMDA)

Medical Device Regulation:

Pharmaceutical and Medical Device Act

Official Language:   

Japanese

Classification:        

Class I, II, III and IV

Registration Process:       

• Class I – PreMarket Submission (Todokede). Only Notification, no review or assessment by PMDA will be conducted
• Class II and some Class III – Premarket Certification (Ninsho). Devices associated with certification standards (JIS) are subjected to Premarket Certification. MAH files the application with the Registered Certification Body (RCB)
• Class III and Class IV – Premarket Approval (Shonin). Devices which are not associated to any certification standard are subject to this process. MAH files a premarket approval application with the PMDA and obtains approval from the MHLW