Marketing Authorization Holders (MAHs) must obtain Marketing Authorization from a registered certification body (RCB) before specified controlled medical devices may be sold in Japan.
The chart below shows where to submit applications for each type and class of medical device/in-vitro diagnostics.
Class | Japanese Classification | Pre-market Requirement | Manufactured in Japan | Manufactured Overseas | MAH |
---|---|---|---|---|---|
IV | Specially-controlled Medical Devices | Approval | Pharmaceutical and Medical Devices Agency (PMDA) | Pharmaceutical and Medical Devices Agency (PMDA) | Permission Required |
III | Specially-controlled Medical Devices | Approval | PMDA | PMDA | Permission Required |
Designated Specially-controlled Medical Devices | Certification | Registered Certification Body(RCB) | Registered Certification Body(RCB) | ||
II | Controlled Medical Devices | Approval | PMDA | PMDA | Notification Required |
QMS | Local Authority Note 1 | PMDA | |||
Designated Controlled Medical Devices | Certification | RCB | RCB | ||
I | General Medical Devices | Notification | PMDA | PMDA | N/A |
II | Designated In-vitro diagnostics Note 2 | Certification | RCB | RCB | Notification Required |