Act on Pharmaceuticals and Medical Devices (PMD Act)
Mandatory Medical Device Approval

Obligations of Marketing Authorization Holders (MAH) and Manufacturers

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
  • Note 1: QMS Audit Agency
  • Note 2: Excluding IVDs that are radiopharmaceuticals