Pharmaceuticals and Medical Devices Law
(Mandatory Approvals in Japan)

Pharmaceuticals and Medical Devices Law

Medical device certification for PAL is certification of Specified Controlled Medical Devices* conducted by a certification body registered with the Minister of Health, Labor and Welfare (MHLW).

* Specified Controlled Medical devices are those among Controlled Medical Devices (Class II) that have requirements specified by MHLW or which are in-vitro diagnostic medical devices (excluding IVD MDs that are radiopharmaceuticals)

Classification of medical devices in PAL:

  • Class I: General Medical Devices (notification is required)
  • Class II: Controlled Medical Devices (specified products require certification by a third-party, all other products require government approval)
  • Class III: Highly-controlled Medical Devices (government approval is required)
  • Class IV: Highly-controlled Medical Devices (government approval is required)

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 diagnostic medical device.

Class Japanese Classification Pre-market Requirement Manufactured in Japan Manufactured Overseas MAH
IV Highly-controlled Medical Devices Note 1 Approval Pharmaceutical and Medical Devices Agency (PMDA) Pharmaceutical and Medical Devices Agency (PMDA) Permission Required
III Highly-controlled Medical Devices Approval PMDA PMDA Permission Required
QMS Local Authority Note 2 PMDA
II Controlled Medical Devices Approval PMDA PMDA Notification Required
QMS Local Authority Note 2 PMDA
Specified Controlled Medical Devices Certification Registered Certification Body (RCB) Registered Certification Body (RCB)
I General Medical Devices Notification PMDA PMDA N/A
II Specified In-vitro Diagnostic Medical Devices Note 3 Certification RCB RCB Notification Required
  • Note 1: Highly-controlled Medical Devices (Class IV) are specified in MHLW Annoucement 430 (December 24, 2004).
  • Note 2: QMS Audit Agency
  • Note 3: Excluding IVD MDs that are radiopharmaceuticals

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