Pharmaceuticals and Medical Device Law (PMDL)
Mandatory Medical Device Approval

Pharmaceuticals and Medical Devices Law

Medical device certification under the PMDL*1 is a third-party certification of applicable medical devices*2 conducted by certification bodies registered under the Ministry of Health, Labor and Welfare (MHLW).

  • *1  The law's full name in Japanese translates to "Law to Ensure Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, and Similar Products," but is often shortened to "Pharmaceuticals and Medical Device Law" or PMDL.
  • *2  Applicable medical devices refers to those Class II and Class III devices and IVDs that have third-party certification requirements specified by MHLW (excluding IVD MDs that are radiopharmaceuticals).

Classification of medical devices:

  • 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 (specified products require certification by a third-party, all other products require government approval)
  • 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 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
Specified Highly-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
Specified Controlled Medical Devices Certification RCB RCB
I General Medical Devices Notification PMDA PMDA N/A
II Specified In-vitro Diagnostic Medical Devices Note 2 Certification RCB RCB Notification Required
  • Note 1: QMS Audit Agency
  • Note 2: Excluding IVD MDs that are radiopharmaceuticals

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