Medical Device Registration in
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
Medical Device Registration in Japan:
- 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
Documents Required:
Depends on the class of the device:
- Development history (previous device versions, global authorizations)
- Product specifications
- Stability studies data
- Compliance with the applicable standards and essential principles
- Performance test data
- Risk Management Plan
- Manufacturing (process, supervision, sterilization)
- Clinical data
Applicable QMS:
Registration Timeline:
Pre-market certification application : 3 months
Application Processing: 6 – 36 months
Authorized Representative:
Yes. Marketing Authorization Holder (MAH)
License Validity:
Unlimited
Special Notes:
Official documents, Package inserts and Labels must be submitted in Japanese